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The five hottest private biotech companies in India – Labiotech.eu

India is brimming with biotech companies and a young and skilled workforce. Heres a quick glance at the private healthcare biotechs in India that captured investors imaginations in the last couple of years.

India has historically been known for its large IT, pharmaceutical and vaccine manufacturing sectors, but is also a force to be reckoned with in the global biotechnology market. The nation boasts around 5,000 biotech companies, with more than 4,000 being startups. This startup count is expected to reach 10,000 by 2024.

With a huge population of young and skilled workers, India has many ingredients for expanding the number of its biotech companies in the coming years. Add to this a large patient pool for lifestyle-related diseases such as type 2 diabetes, and there is a large potential for generating innovations in healthcare.

Weve assembled a shortlist of the hottest private biotech companies in India by checking whos raised impressive cash in the last few years. These companies are carrying out innovative healthcare research and are primarily based in Mumbai and Bengaluru.

Founded: 2014

Headquarters: Bengaluru, India and Saratoga, U.S.

Bugworks has multiple sites in the U.S. and Australia with a research and development base in India. The firm specializes in the development of antibiotics that could address the growing crisis of antimicrobial resistance.

Bugworks lead candidate antibiotic blocks the replication machinery in invading bacteria. In addition, the drug is designed to bypass normal resistance mechanisms in bacteria, which could make it harder for strains to become resistant to the treatment.

The company is testing its antibiotic in phase 1 trials for the treatment of multi-drug resistant infections in collaboration with the nonprofit initiatives CARB-X and the Global Antibiotic Research and Development Partnership (GARDP).

Bugworks is financing its antibiotics research with a $18 million Series B1 round closed in February 2022. In addition, Bugworks will use the proceeds to fund the preclinical development of a dual-acting drug to treat cancer.

Founded: 2012

Headquarters: Mumbai

Epigeneres Biotech hit the headlines in January 2022 with a $6 million Series B funding round. The Indian biotech company is using the cash to develop a wide range of different technologies in its arsenal, including cancer tests, nanotechnology-based medicines and nutraceuticals.

Cancer detection is Epigeneres most recent pursuit. In 2021, the firm teamed up with the Singaporean company Tzar Labs to develop cancer diagnostics that screen for telltale RNA molecules from tumors at early stages of disease. Epigeneres is poised to launch a screening service in India based on the technology.

Epigeneres also has nucleic acid drugs in development for the treatment of conditions ranging from infertility to renal failure to autoimmune diseases. The firm uses a form of nanotechnology to boost the delivery of the drugs to the target cells.

In addition, Epigeneres is working on small molecule drugs that can increase the population of stem cells in the body in a regenerative medicine setting.

Founded: 2016

Headquarters: Bengaluru

In August 2022, Eyestem caught the eye of investors in a $6.4 million Series A round. The Indian biotech startup is working on cell therapies for eye disorders, with a flagship therapy in the pipeline for the treatment of dry age-related macular degeneration (dry AMD).

There is currently no treatment for dry AMD. In patients with the condition, the eye accumulates cellular debris, which causes destructive inflammation in the retina. This leads to a loss of retinal pigment epithelium, the layer of cells that support the photosensitive cells we need to see.

Eyestem is developing an off-the-shelf stem cell therapy to replace lost retinal pigment epithelium. The biotech has earmarked money from its recent Series A round for preparing its cell therapy for early-stage clinical testing.

Founded: 2019

Headquarters: Bengaluru

Immuneel Therapeutics is making waves in the field of autologous CAR-T cell therapy, where a patients immune T cells are removed, engineered in the lab to kill blood cancer cells, and reinfused into the patient. There are CAR-T therapies already available, but these complex, expensive therapies are currently limited to only the wealthiest countries.

Immuneels mission is to develop CAR-T therapies that are accessible and affordable in India. To support this push, the company raised $15 million in June 2022 in a Series A round.

The therapies in Immuneels pipeline are targeted to various types of blood cancer in children and adult patients. As the Indian biotech closed its Series A round, Immuneel kicked off a phase 2 trial of a CAR-T therapy in what it claims is the first industry-sponsored CAR-T trial in India.

Founded: 2013

Headquarters: Bengaluru and Wilmington, U.S.

MedGenome has sites around the globe, with a large part of its operations and genetic testing situated in, and targeted to, India.

The company carries out genomics-focused research and diagnostics services for biopharma clients that can help in the development of drugs tackling cancer, diabetes, eye conditions and cardiovascular diseases. To provide a rich dataset, the company works with more than 500 hospitals in India.

MedGenome raised one of the Asia-Pacific regions biggest biotech investments in August 2022 a $50 million round led by Novo Holdings. The funds will be used to increase access to genetic testing in emerging markets, which have lagged behind the wealthier parts of the world.

MedGenome also aims to collect genetic data from a wide range of populations in Asia, which could provide a treasure trove of clinical insights for genes related to disease. In keeping with this aim, the company is a founding member of the initiative GenomeAsia 100K, which will analyze the genomes of 100,000 people from a range of Asian populations to speed up the development of precision medicine in this part of the world.

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The five hottest private biotech companies in India - Labiotech.eu

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Doctor Innovates Cell Therapy in India; Seeks to Make Vision Restoration 80% Cheaper – The Better India

For Dr Jogin Desai, CEO and co-founder of Eyestem, a leading Indian cell therapy company, a meeting in 2015 with ophthalmologist Dr Rajani Battu for a medical appointment changed everything. Following the appointment, she introduced him to patients diagnosed with degenerative diseases of the eye and the terrible suffering they have to endure.

It was an eye-opener for Desai, a native of Ahmedabad and an expert in the field of drug development. Desai, at the time, was CEO of Cenduit, an industry leader in the IRT (interactive response technology) market and the eClinical field.

From school students who cannot see their blackboards to families with children suffering from blindness because of genetic disorders and senior citizens who have lost all agency due to their inability to read, the conversation opened my eyes to a world that I didnt know existed. In the same week, I met Prof S. Ramaswamy at Instem (Institute for Stem Cell and Regenerative Medicine), again for something completely unrelated, and we discussed the possibilities of how the next two-three decades will evolve with the maturation of cell and gene therapy products worldwide, recalls Desai, in a conversation with The Better India.

Following the meeting, it dawned on Desai at the time that the world is on the cusp of a fundamental change in the healthcare landscape that will evolve over the next few decades.

Today, Dr Rajani Battu is the chief medical officer at Eyestem.

Diseases that were previously incurable will start becoming curable. As I dove deeper, I understood that most of these therapies developed in the West will cost upwards of $450,000 (about Rs 3.5 Crore) per injection. This, I believe, presented a once-in-a-lifetime opportunity for a platform that can help disrupt this paradigm and create an incredible impact on the lives of patients. I made the decision to establish Eyestem within two days of these meetings in late 2015, adds Desai.

Eyestems vision is to create a scalable cell therapy platform to treat incurable diseases and democratise access to these newer technologies.

Incorporated in late 2015, Eyestem started operations in early 2017.

As cell and gene therapies become available across the world, they will only be available to the top 0.01 % of the worlds population. Our purpose is simple: We aim to democratise access by creating a therapy that is available to a large part of the bottom 99.99% of the population in the world. To our knowledge, we are the only company in the world with such a mission. While it is hard to predict the price of the therapy at this stage we anticipate the therapy to cost 80-90% cheaper than such comparable therapies in the West. The only purpose to start Eyestem has been ensuring that the therapy reaches the people that need it the most, claims Desai.

Through its flagship product Eyecyte-RPE, the company replaces lost retinal pigment epithelium cells. It is designed to restore sight for patients in the early stages of Age-Related Macular Degeneration (AMD) and arrest losses for those in the later stages.

There is no cure for Dry Age-Related Macular Degeneration in the world. It is the largest cause of blindness for people over 50. It is estimated that over 170 million people (40 million of which are in India) suffer from this disease. Eyestem is looking to take Eyecyte-RPE for Dry AMD through clinical trials and is one of six companies worldwide pursuing this treatment, he says.

Underpinning this type of treatment are Induced-Pluripotent Stem Cell (iPSC)-based products. An iPSC is a cell that can be developed into any cell of the body. At present, there are no iPSC-based products approved anywhere in the world.

Over the next ten years, Desai explains that several such products will start becoming available in the market and diseases such as inherited blindness/pulmonary fibrosis/diabetes which were hitherto considered incurable will start becoming curable.

Subsequently, an explosion in iPSC based therapeutics combined with gene engineering will be the next wave of pharma innovation. A lot of diseases occur when the cells of our body die early or are malfunctioning. At its most basic detail, one can create tissue of any kind (be it brain, heart, lung, eye, liver, kidney) through iPSC and replace the lost/damaged cells of the body. For example, in Dry AMD, the RPE layer degenerates and our treatment would be to inject that layer (from a healthy donor) back into the body part to treat the disease, he explains.

Curing Incurable Blindness and Other Diseases

So, how does Eyestems flagship product, Eyecte-RPE, work as a mode of treatment?

The Retinal Pigment Epithelium (RPE) is one of ten layers of the retina and acts as a foundation on which the rest of the retina sits. In Dry AMD, the RPE layer disintegrates and the retinal layers disintegrate just as a building collapses when the foundation collapses.

We have grown the RPE layer in our lab and this is Eyecyte-RPE, our flagship product. This product has been injected into special models of blind rats. We have proven that the rats where our product is injected can retain their sight while the ones that are controlled rats go blind. This animal experiment has been done at Oregon Health and Science University which is a global centre of excellence for macular degeneration research. The DCGI (Drugs Controller General of India) has approved manufacturing only for clinical trials and we have not yet applied for commercial manufacturing, he explains.

In addition to this, Eyestem is also among one of five companies globally advancing the treatment of Retinitis Pigmentosa (RP) to the market called Eyecyte-PRP. Eyecyte-PRP replaces the photoreceptor cells that are lost as a consequence of this disease. RP is a group of rare, genetic disorders that involve loss of the light-sensing photoreceptor cells in the retina. It affects children and causes total blindness by the time they reach their 20s and 30s. It is estimated to affect 4 million children worldwide, of which 1.5 million are in India. Human trials for Eyecyte-PRP to treat retinitis pigmentosa is expected to begin in the second half of FY 2023.

Similarly, Eyestem is also looking to treat Idiopathic Pulmonary Fibrosis (IPF), a serious chronic disease that affects the tissue surrounding the alveoli (tiny air sacs in your lungs), with a pluripotent stem cell-based approach.

Our first human trials for our Aircyte-AEC treatment to treat idiopathic pulmonary fibrosis will begin in the second half of FY2024. Aircyte-AEC is a suspension of lung alveolar epithelial cells that are lost due to this disease. It is worth noting that pulmonary fibrosis occurs as an end-stage event in several other diseases like COVID-19, Tuberculosis and Chronic Obstructive Pulmonary Disease, notes Desai.

Meanwhile, for the sake of clarification, we asked Desai whether cell therapy necessarily means stem cell therapy? Yes, it means the same from a laymans perspective. The only difference is that there are clinics that advertise stem cell therapy for patients in India as well as the US. It is important to remember that none of these stem cell therapy products are approved by the DCGI in India or the FDA in the United States, he notes.

State of Cell Therapy in India, Funding and Moving Ahead

There are only a handful of companies in India that are pursuing cell therapy. According to Desai, the developed world, especially countries like Israel, Japan and the United States, are at least two decades ahead of India in that regard.

As more incurable diseases become curable (think diabetes or cancer) it is absolutely imperative for India to develop a base of such product development research or else we will find ourselves in a situation similar to the HIV epidemic (and cell therapy is not easy to reverse engineer unlike HIV medicines). Our patients will be at the mercy of predatory pricing of global pharma unless globally innovative products are manufactured and made available locally. Our nine-member team at Eyestem, a majority of whom are cell biology scientists specializing in this field, is looking to significantly address this issue in advance, says Desai.

Meanwhile, Desai claims that his venture has been very selective in raising funds so far since its purpose is not to raise rounds of money with higher valuations but to benefit end patients. They are laser-focused on creating affordable cell therapy and hence have set themselves a benchmark of not spending more than $4 million from idea to first in human trials. Most pharmaceutical companies, he claims, spend 10 times this amount to reach this stage.

Any drug development venture needs smart money. We were fortunate to have interest from a group of investors who have multi-decade experience in global drug development. Two institutional investors (Endiya Partners and Kotak Private Equity) joined in a subsequent pre-series A round. We are currently raising our series A and we are halfway there. About 30% has been committed by current shareholders and we have a soft commitment from a global venture fund for the other 20%. We anticipate closing this round in the next 8-12 weeks. Investors invest in ventures like ours due to the promise of immense market potential for these therapies. As soon as one obtains human data, startups like ourselves reach an inflexion point and become extremely valuable, claims Desai.

Please Note: The Better India does not verify for the future efficacy of any therapy or medical treatment mentioned in the article. Kindly consult your doctor for an informed medical opinion.

(Edited by Vinayak Hegde)

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Doctor Innovates Cell Therapy in India; Seeks to Make Vision Restoration 80% Cheaper - The Better India

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Retinal Disorders Treatment Market: Advancements in Gene-therapy and Stem-cell Therapy to Bolster Market Growth – BioSpace

Retinal Disorders Treatment Market: Introduction

According to the report, the global retinal disorders treatment market was valued at US$ 9.18 Bn in 2019 and is projected to expand at a CAGR of ~7% from 2020 to 2030. Macular degeneration is of two types: wet age-related macular degeneration and dry age-related macular degeneration. Diabetic retinopathy is one of the common diabetic eye disorders characterized by damaged blood vessels in the retina. Damaged blood vessels and nerves lead to vision impairment, blurring of vision, and eye hemorrhage. If left untreated, it could lead to retinal detachment and blindness. In terms of indication, the global retinal disorders treatment market has been classified into macular degeneration, diabetic retinopathy, diabetic macular edema, and others. The macular degeneration segment has been bifurcated into dry macular degeneration and wet macular degeneration. Based on therapeutic class, the global retinal disorders treatment market has been categorized into anti-VEGF agents and others. In terms of dosage form, the global retinal disorders treatment market has been divided into gels, eye solutions, capsules & tablets, eye drops, and ointments.

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Based on distribution channel, the global retinal disorders treatment market has been segregated into hospital pharmacies, retail pharmacies, and online sales. Rise in prevalence of retinal disorders due to increase in geriatric patient population boosts the growth of the global retinal disorders treatment market. The U.S. dominated the global retinal disorders treatment market in 2019, and the trend is anticipated to continue during the forecast period. Well-established healthcare infrastructure and early adoption of advanced technologies are the factors expected to fuel the growth of the market in the region. Moreover, rise in prevalence of various types of retinal disorder leads to increase in demand for treatment.

China is likely to be a highly lucrative market for retinal disorders treatment during the forecast period. Diagnosis and treatment rates have increased due to a rise in disposable income and health awareness. This has led to an increase in the adoption of macular degeneration drugs

Rise in Prevalence of Retinal Disorders Due to Increase in Geriatric Patient Population to Drive Global Market

Age is a prominent risk factor for age-related macular degeneration. The risk of developing advanced age-related macular degeneration increases from 2% in people aged between 50 and 59 to nearly 30% for those over 75. The prevalence of other retinal disorders was 93 million people with diabetic retinopathy, 21 million people diabetic macular edema and 28 million people with vision-threatening diabetic retinopathy. Increase in R&D activities, rise in the number of patients suffering from diseases, and rapid expansion of healthcare and biopharmaceutical industries in developed and developing countries are projected to boost advancements in therapies in the AMD treatment market during the forecast period. For instance, Lucentis and Eylea accounted for 2.8% of total pharmaceutical sales in Canada in 2017.

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Macular Degeneration to Dominate Global Market

In terms of indication, the global retinal disorders treatment market has been divided into macular degeneration, diabetic retinopathy, diabetic macular edema, and others. Macular degeneration has been bifurcated into dry macular degeneration and wet macular degeneration. The macular degeneration segment dominated the market in terms of revenue in 2019. The rise in prevalence of macular degeneration is anticipated to drive the segment during the forecast period. For instance, the number of people living with macular degeneration is expected to reach 196 million globally by 2020 and increase to 288 million by 2040.

Anti-VEGF Agents to be Main Therapeutic Class

Based on therapeutic class, the global retinal disorders treatment market has been categorized into anti-VEGF agents and others. The anti-VEGF agents dominated the global retinal disorders treatment market in 2019. Major market products such as Avastin and Eylea are included in the anti-VEGF drug class. Increase in demand for these products in the treatment of retinal disorders and strong product pipeline are likely to drive the segment. However, the others segment, which includes anti-inflammatory drugs, is projected to expand at the highest CAGR from 2020 to 2030. The increase in the use of anti-inflammatory drugs for pain relief is anticipated to augment the segment.

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Eye Solutions to be Preferred Dosage Form

In terms of dosage form, the global retinal disorders treatment market has been divided into gels, eye solutions, capsules & tablets, eye drops, and ointments. The eye solutions segment dominated the global retinal disorders treatment market in 2019. However, the eye drops segment is expected to expand at the highest CAGR during the forecast period. The segment is likely to grow at a rapid pace due to increase in demand for eye drops for treatment of retinal diseases in emerging countries such have China, India, and Brazil.

Retail Pharmacies to Emerge as Major Distribution Channel

Based on distribution channel, the global retinal disorders treatment market has been segregated into hospital pharmacies, retail pharmacies, and online sales. The retail pharmacies segment dominated the market in terms of revenue in 2019 due to wide network, ease of access, and diverse product offerings, including prescription and OTC ophthalmic drugs. However, the shift toward the use of electronic payment modes is projected to boost the growth of the online sale segment during the forecast period.

U.S. to Dominate Global Market

The global retinal disorders treatment market has been segmented into five major regions/country: the U.S., Europe, China, Russia, and Rest of the World. The U.S. dominated the global market in 2019, followed by Europe. The U.S. accounted for a major share of the global retinal disorders treatment market in 2019. Well-developed healthcare infrastructure, high healthcare expenditure, and adoption of branded drugs to treat retinal disorder disorders are the key factors attributed to the countrys significant share of the global market.

The retinal disorders treatment market in China is anticipated to expand at a high CAGR from 2020 to 2030. There have been significant unmet medical needs in the region. Furthermore, healthcare expenditure is increasing in developing markets. Key players are making investments to establish their operations in China. This, in turn, is projected to augment the market in the country.

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Competition Landscape

Regeneron Pharmaceuticals, Inc., F. Hoffmann-La Roche Ltd., and Novartis AG are the three major companies operating in the global retinal disorders treatment market. The global retinal disorders treatment market is fragmented in terms of number of players. Key players in the global market include Allergan plc, Bayer AG, F. Hoffmann-La Roche Ltd., Graybug Vision, Inc., Kubota Pharmaceutical Holdings Co., Ltd., Novartis AG, Pfizer, Inc., Regeneron Pharmaceuticals, Inc., Santen Pharmaceutical Co., Ltd., and Takeda Pharmaceutical Company Limited. New product development through robust R&D activities and mergers & acquisitions are key strategies adopted by these players to gain a competitive advantage in the global retinal disorders treatment market.

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Retinal Disorders Treatment Market: Advancements in Gene-therapy and Stem-cell Therapy to Bolster Market Growth - BioSpace

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Gene Therapy and Editing : Novel options for inherited retinal blindness – ETHealthworld.com

(Representative image) by Dr. Indumathi MariappanResearch Scientist, LV Prasad Eye Institute, Hyderabad

Retinal Blindness

Millions of people the world over suffer visual disability as a result of retinal dystrophy that involves the death of retinal cells that are important for the light sensing function of the eye. Enormous progress has been made in other blinding conditions involving the cornea, lens, among others. However, the retinal dystrophies and optic nerve atrophies do not have any proven therapy till date. The major forms of retinal dystrophies such as Age-related macular degeneration (AMD), retinitis pigmentosa (RP), Lebers congenital amaurosis (LCA), Stargardts disease etc. are either inherited disorders or developed with aging. In most cases, the retinal cells are present at birth, but undergo gradual death during the later stages of life. It is typically characterized by initial symptoms of low vision and night blindness during early childhood, which progresses to severe visual impairment and total blindness at different stages of adulthood. Inherited defects in many genes involved in retina-specific functions and vitamin A metabolism are linked to various forms of retinal dystrophies. These genetic defects affect the normal cellular functions of the retina, leading to gradual cell death and ultimately the patient becomes legally blind.

Recent Technologies and Novel Treatment Options

The current modalities for the treatment of such patients mainly include dietary supplements, visual aids and rehabilitation support. However, a radical approach is required either to preserve or to restore visual function in these patients. Some of them include the replacement of either the lost retinal cells or the defective genes within the surviving, but non-functional retinal cells. This has been the principle behind the massive efforts involved in the development of cell and gene-based therapies. They are currently at different stages of product development and clinical trial evaluation. In cell therapy, normal retinal cells are prepared from specialized stem cells and are injected into the eye to replace the lost cells and to restore retinal functions. Clinical safety trials using cell therapy are ongoing in many countries such as USA, Japan, UK and others (Weblinks 1-4). In gene therapy, the prime strategy is to introduce a normal copy of the affected gene into the surviving retinal cells of the patient, to restore normal cellular functions and improvements in vision. This is achieved by engineering safe viral vectors to carry a normal copy of the desired gene as their cargo. When injected into the eye, the viruses can infect the retinal cells once and deliver the normal gene to restore cellular functions (Weblinks 5-7). A step further is an advanced method of DNA microsurgery, wherein, the defective part of the retinal cell DNA is precisely edited to correct the genetic defect and to restore cellular functions. This could be achieved using the latest gene editing tools such as ZFNs, TALENs, CRISPR/Cas systems etc. These are naturally occurring molecular scissors, employed as host defense mechanism and immune memory to combat viral infections in different species of bacteria. These systems are now engineered to enable DNA and RNA editing in almost any living cells. Such tools are now combined with either cell therapy or gene therapy to develop novel drugs for the treatment of various inherited genetic diseases (Weblink 8).

Gene therapy products approved for clinical use:

LUXTURNATM (Weblink 5)

This is the first commercial gene therapy drug approved by the US-FDA and European Commission for the treatment of an early childhood retinal dystrophic condition called the Leber Congenital Amaurosis 2 (LCA2). This disease is caused due to genetic defects in the gene called RPE65. LUXTURNA (AAV2-hRPE65v2 or Voretigene neparovec-rzyl) is an engineered adeno-associated virus 2 (AAV2) vector carrying a normal copy of the human RPE65 gene. This product was developed and marketed by Spark Therapeutics, a US-based startup now owned by Roche, a Swiss pharma company.

This drug has been tested on 20 patients, aged 3 years or older, in a randomized, controlled, open label, phase 3 interventional clinical trial at two sites in the US from June 2015. All treated individuals showed significantly improved functional vision, with no product-related serious adverse events or deleterious immune responses. The treated patient will be followed for further 15 years until March 2030 to assess the long-term retinal gene expression and stable maintenance of functional vision. It is administered as a onetime injection behind the retina of an eye of patients genetically diagnosed to carry mutations in RPE65 gene and also have sufficient viable retinal cells. It is priced at $850,000 for two eyes in the US and UK, which translates to about 6.5 crores in Indian rupees.

Many such gene therapy vectors are currently under clinical trial evaluation for the delivery of other retinal gene such as REP1, PDE6B, RPGR, OAT (Ornithine aminotransferase), MERTK, sFLT1etc.

EDIT101 (Weblink 8)

This is the first gene editing based drug approved by US-FDA, for the treatment of another early childhood retinal dystrophic condition called LCA10, caused by defects in the CEP290 gene. Here, it is important to understand that a gene editing approach is different from a gene therapy. In gene therapy, a normal copy of entire gene is delivered to the retina to complement the defective gene. In CRISPR/Cas9 based gene editing, only the mutated region of the gene is edited/corrected in situ inside the target cells. This is an attractive approach for correcting a variety of gene mutations, especially those in large genes which exceed the cargo capacity of the commonly used AAV-based gene therapy vectors.

EDIT101 (AGN-151587) is an engineered adeno-associated virus 5 (AAV5) vector carrying a CRISPR/Cas9 based DNA editing machinery to locate and remove a specific mutation hotspot within the intron 26 of human CEP290 gene. When injected behind the retina, the virus will infect the surviving photoreceptor cells and deliver the CRISPRs to enable mutation editing. Successful DNA edits in photoreceptor cells would inactivate a spurious splice site created by the mutation and restore normal protein expression and retinal function.

Preclinical testing in mice and monkey eyes has proved significant edit efficiency of up to 28%, which was above the expected 10% threshold required for clinical efficacy in human trials. This drug was developed by the gene editing company, Editas Medicine, Inc. and is being tested in 18 participants in a Phase 1/2 clinical trial sponsored by Allergan, at four sites in the US from March 2019 and the outcomes are awaited.

Similar gene editing strategy is being explored at different centers for mutation correction in other retinal genes such as KCNJ13, RP1, USH2A, MYO7A, RDH12 etc.

Who can benefit?

Both gene therapy and gene editing approaches have opened up newer hopes for the treatment of various genetic condition affecting different cell types of the body. However, only a small subset of patients can benefit from such therapies at the moment. Such treatment considerations require a thorough genetic screening/genotyping to confirm the identity of the gene affected in a specific patient. Further, the patients should retain some viable cells in the retina for the treatment to be clinically effective.

Research efforts in India

Many labs in the country are developing gene therapies and gene editing based therapeutics for the treatment of various diseases affecting the blood, retina, liveretc. Researchers at the CMC, Vellore, CSIR-IGIB, Delhi, CSIR-CCMB, Hyderabad are developing gene therapeutics for the treatment of different forms of blood disorders. Narayana Nethralaya, Bangalore is engaged in developing AAV-based gene therapies for various retinal dystrophies. Our lab at the LV Prasad Eye Institute is collaborating with the research teams at IIT-Kanpur and CSIR-IGIB, Delhi to develop modified gene therapy vectors for retinal gene delivery and cell-based therapies using CRISPR edited stem cells and retinal cells respectively.

The way forward

As of May 2020, the RetNet database lists about 271 genes to be associated with different forms of retinal dystrophies. This requires a larger library of gene delivery vectors to be developed and made available at affordable costs for the treatment of a large number of patients. This mandates the need for developing indigenous and cost-effective therapeutics and ICMR has set up a dedicated task force on gene therapy research, to identify and support promising research ideas in this newly emerging area of biomedical research. A national guideline for gene therapy product development and clinical trials has been jointly formulated and released by the DBT and ICMR in 2019. It is hoped that the streamlined regulatory framework would fast track our basic and translational research efforts into developing novel and cost-effective treatment options in the near future.

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Medical Tourism Corporation Announces Stem Cell Therapy in Mexico With GIOSTAR – NBC Right Now

The two entities join hands for all-inclusive stem cell treatment in Los Algodones, Tijuana, and Guadalajara. Package includes personalized therapy protocol, travel assistance, and more. GIOSTAR is a global stem cell leader with more than 4,000 people treated.

DALLAS-August 14, 2017- (Newswire.com)

The major medical tourism facilitator has added another much-needed treatment to its comprehensive list of medical services, stem cell treatment in Mexico, as a way of helping people with degenerative, immunological, and blood-based diseases receive alternative healthcare and lead a happy, healthy life.

About GIOSTAR Mexico

Founded by a leading stem cell scientist, Dr. Anand Srivastava who is credited with setting up stem cell research programs in Sal Research Institute, UCSD, UCI and Sanford Burnham Institute, GIOSTAR is a visionary organization in the field. With its headquarters in San Diego and multiple top-notch facilities, offices and hospitals in various locations including India, Mexico, Brazil and Colombia, the venture is expanding its reach and making treatment for several devastating immunological and blood- related diseases accessible for all.

GIOSTAR Mexico offers stem cell therapy in Tijuana, Guadalajara, and Los Algodones. Current treatments include Diabetes Type I and Type II, Lupus, Multiple Sclerosis, Crohn's disease, and Spinal Cord Injuries (SCI), among others. The therapies for Alzheimer's, Autism, Anti-Aging Treatments, Parkinson's disease, Heart and Retinal Degeneration, and many more diseases are being developed by the dedicated and skilled members of the institute.

Some prominent features of GIOSTAR are:

About Medical Tourism Corporation (MTC)

The Texas-based Medical Tourism Corporation is a Better Business Bureau (BBB) accredited health tourism organizer. The corporation aims to connect medical tourists from all over the world to excellent healthcare services without the underlying stress. The most daunting part of the medical tourism process is the lack of information about quality treatments in Mexico, India, and other health tourism hubs. MTC emerges as a helping hand, and assists its customers in planning every little detail of their medical trip and even offers generous post-op services and follow-up care for a safe recovery.

With the introduction of alternative therapies for taxing and draining conditions, such as stem cells for Parkinson's in Mexico, the organization is expanding its arsenal of services and treatments offered.

Medical Tourism Corporation has recently partnered with GIOSTAR with the goal of making quality healthcare come true. The two entities have collaborated to offer personalized protocols for various conditions and injuries, including stem cell therapy for spinal injuries in Mexico.

Aiming to provide exemplary stem cell treatment in Mexico, MTC provides a host of services and features that set the venture apart:

What to Expect?

The National Institutes of Health (NIH) estimates up to 23.5 million Americans suffer from autoimmune diseases. All that is standing between these patients and life-altering medical treatments is a border away.

This timely collaboration between GIOSTAR and MTC is an important step forward in bridging the gap between demand and supply of effective alternative treatments for people suffering from the aforementioned ailments when conventional therapies fail to treat. More information on stem cell therapy in Mexico is available on the official website of Medical Tourism Corporation.

Related LinksStem Cell Treatment for Diabetes Type 1 and 2 in MexicoStem Cell Treatment for Arthritis in Mexico

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Medical Tourism Corporation Announces Stem Cell Therapy in Mexico With GIOSTAR - NBC Right Now

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Stem-cell therapy – Wikipedia

This article is about the medical therapy. For the cell type, see Stem cell.

Stem-cell therapy is the use of stem cells to treat or prevent a disease or condition.

Bone marrow transplant is the most widely used stem-cell therapy, but some therapies derived from umbilical cord blood are also in use. Research is underway to develop various sources for stem cells, and to apply stem-cell treatments for neurodegenerative diseases and conditions such as diabetes, heart disease, and other conditions.

Stem-cell therapy has become controversial following developments such as the ability of scientists to isolate and culture embryonic stem cells, to create stem cells using somatic cell nuclear transfer and their use of techniques to create induced pluripotent stem cells. This controversy is often related to abortion politics and to human cloning. Additionally, efforts to market treatments based on transplant of stored umbilical cord blood have been controversial.

For over 30 years, bone marrow has been used to treat cancer patients with conditions such as leukaemia and lymphoma; this is the only form of stem-cell therapy that is widely practiced.[1][2][3] During chemotherapy, most growing cells are killed by the cytotoxic agents. These agents, however, cannot discriminate between the leukaemia or neoplastic cells, and the hematopoietic stem cells within the bone marrow. It is this side effect of conventional chemotherapy strategies that the stem-cell transplant attempts to reverse; a donor's healthy bone marrow reintroduces functional stem cells to replace the cells lost in the host's body during treatment. The transplanted cells also generate an immune response that helps to kill off the cancer cells; this process can go too far, however, leading to graft vs host disease, the most serious side effect of this treatment.[4]

Another stem-cell therapy called Prochymal, was conditionally approved in Canada in 2012 for the management of acute graft-vs-host disease in children who are unresponsive to steroids.[5] It is an allogenic stem therapy based on mesenchymal stem cells (MSCs) derived from the bone marrow of adult donors. MSCs are purified from the marrow, cultured and packaged, with up to 10,000 doses derived from a single donor. The doses are stored frozen until needed.[6]

The FDA has approved five hematopoietic stem-cell products derived from umbilical cord blood, for the treatment of blood and immunological diseases.[7]

In 2014, the European Medicines Agency recommended approval of Holoclar, a treatment involving stem cells, for use in the European Union. Holoclar is used for people with severe limbal stem cell deficiency due to burns in the eye.[8]

In March 2016 GlaxoSmithKline's Strimvelis (GSK2696273) therapy for the treatment ADA-SCID was recommended for EU approval.[9]

Stem cells are being studied for a number of reasons. The molecules and exosomes released from stem cells are also being studied in an effort to make medications.[10]

Research has been conducted on the effects of stem cells on animal models of brain degeneration, such as in Parkinson's, Amyotrophic lateral sclerosis, and Alzheimer's disease.[11][12][13] There have been preliminary studies related to multiple sclerosis.[14][15]

Healthy adult brains contain neural stem cells which divide to maintain general stem-cell numbers, or become progenitor cells. In healthy adult laboratory animals, progenitor cells migrate within the brain and function primarily to maintain neuron populations for olfaction (the sense of smell). Pharmacological activation of endogenous neural stem cells has been reported to induce neuroprotection and behavioral recovery in adult rat models of neurological disorder.[16][17][18]

Stroke and traumatic brain injury lead to cell death, characterized by a loss of neurons and oligodendrocytes within the brain. A small clinical trial was underway in Scotland in 2013, in which stem cells were injected into the brains of stroke patients.[19]

Clinical and animal studies have been conducted into the use of stem cells in cases of spinal cord injury.[20][21][22]

The pioneering work[23] by Bodo-Eckehard Strauer has now been discredited by the identification of hundreds of factual contradictions.[24] Among several clinical trials that have reported that adult stem-cell therapy is safe and effective, powerful effects have been reported from only a few laboratories, but this has covered old[25] and recent[26] infarcts as well as heart failure not arising from myocardial infarction.[27] While initial animal studies demonstrated remarkable therapeutic effects,[28][29] later clinical trials achieved only modest, though statistically significant, improvements.[30][31] Possible reasons for this discrepancy are patient age,[32] timing of treatment[33] and the recent occurrence of a myocardial infarction.[34] It appears that these obstacles may be overcome by additional treatments which increase the effectiveness of the treatment[35] or by optimizing the methodology although these too can be controversial. Current studies vary greatly in cell-procuring techniques, cell types, cell-administration timing and procedures, and studied parameters, making it very difficult to make comparisons. Comparative studies are therefore currently needed.

Stem-cell therapy for treatment of myocardial infarction usually makes use of autologous bone-marrow stem cells (a specific type or all), however other types of adult stem cells may be used, such as adipose-derived stem cells.[36] Adult stem cell therapy for treating heart disease was commercially available in at least five continents as of 2007.[citation needed]

Possible mechanisms of recovery include:[11]

It may be possible to have adult bone-marrow cells differentiate into heart muscle cells.[11]

The first successful integration of human embryonic stem cell derived cardiomyocytes in guinea pigs (mouse hearts beat too fast) was reported in August 2012. The contraction strength was measured four weeks after the guinea pigs underwent simulated heart attacks and cell treatment. The cells contracted synchronously with the existing cells, but it is unknown if the positive results were produced mainly from paracrine as opposed to direct electromechanical effects from the human cells. Future work will focus on how to get the cells to engraft more strongly around the scar tissue. Whether treatments from embryonic or adult bone marrow stem cells will prove more effective remains to be seen.[37]

In 2013 the pioneering reports of powerful beneficial effects of autologous bone marrow stem cells on ventricular function were found to contain "hundreds" of discrepancies.[38] Critics report that of 48 reports there seemed to be just five underlying trials, and that in many cases whether they were randomized or merely observational accepter-versus-rejecter, was contradictory between reports of the same trial. One pair of reports of identical baseline characteristics and final results, was presented in two publications as, respectively, a 578 patient randomized trial and as a 391 patient observational study. Other reports required (impossible) negative standard deviations in subsets of patients, or contained fractional patients, negative NYHA classes. Overall there were many more patients published as having receiving stem cells in trials, than the number of stem cells processed in the hospital's laboratory during that time. A university investigation, closed in 2012 without reporting, was reopened in July 2013.[39]

One of the most promising benefits of stem cell therapy is the potential for cardiac tissue regeneration to reverse the tissue loss underlying the development of heart failure after cardiac injury.[40]

Initially, the observed improvements were attributed to a transdifferentiation of BM-MSCs into cardiomyocyte-like cells.[28] Given the apparent inadequacy of unmodified stem cells for heart tissue regeneration, a more promising modern technique involves treating these cells to create cardiac progenitor cells before implantation to the injured area.[41]

The specificity of the human immune-cell repertoire is what allows the human body to defend itself from rapidly adapting antigens. However, the immune system is vulnerable to degradation upon the pathogenesis of disease, and because of the critical role that it plays in overall defense, its degradation is often fatal to the organism as a whole. Diseases of hematopoietic cells are diagnosed and classified via a subspecialty of pathology known as hematopathology. The specificity of the immune cells is what allows recognition of foreign antigens, causing further challenges in the treatment of immune disease. Identical matches between donor and recipient must be made for successful transplantation treatments, but matches are uncommon, even between first-degree relatives. Research using both hematopoietic adult stem cells and embryonic stem cells has provided insight into the possible mechanisms and methods of treatment for many of these ailments.[citation needed]

Fully mature human red blood cells may be generated ex vivo by hematopoietic stem cells (HSCs), which are precursors of red blood cells. In this process, HSCs are grown together with stromal cells, creating an environment that mimics the conditions of bone marrow, the natural site of red-blood-cell growth. Erythropoietin, a growth factor, is added, coaxing the stem cells to complete terminal differentiation into red blood cells.[42] Further research into this technique should have potential benefits to gene therapy, blood transfusion, and topical medicine.

In 2004, scientists at King's College London discovered a way to cultivate a complete tooth in mice[43] and were able to grow bioengineered teeth stand-alone in the laboratory. Researchers are confident that the tooth regeneration technology can be used to grow live teeth in human patients.

In theory, stem cells taken from the patient could be coaxed in the lab turning into a tooth bud which, when implanted in the gums, will give rise to a new tooth, and would be expected to be grown in a time over three weeks.[44] It will fuse with the jawbone and release chemicals that encourage nerves and blood vessels to connect with it. The process is similar to what happens when humans grow their original adult teeth. Many challenges remain, however, before stem cells could be a choice for the replacement of missing teeth in the future.[45][46]

Research is ongoing in different fields, alligators which are polyphyodonts grow up to 50 times a successional tooth (a small replacement tooth) under each mature functional tooth for replacement once a year.[47]

Heller has reported success in re-growing cochlea hair cells with the use of embryonic stem cells.[48]

Since 2003, researchers have successfully transplanted corneal stem cells into damaged eyes to restore vision. "Sheets of retinal cells used by the team are harvested from aborted fetuses, which some people find objectionable." When these sheets are transplanted over the damaged cornea, the stem cells stimulate renewed repair, eventually restore vision.[49] The latest such development was in June 2005, when researchers at the Queen Victoria Hospital of Sussex, England were able to restore the sight of forty patients using the same technique. The group, led by Sheraz Daya, was able to successfully use adult stem cells obtained from the patient, a relative, or even a cadaver. Further rounds of trials are ongoing.[50]

In April 2005, doctors in the UK transplanted corneal stem cells from an organ donor to the cornea of Deborah Catlyn, a woman who was blinded in one eye when acid was thrown in her eye at a nightclub. The cornea, which is the transparent window of the eye, is a particularly suitable site for transplants. In fact, the first successful human transplant was a cornea transplant. The absence of blood vessels within the cornea makes this area a relatively easy target for transplantation. The majority of corneal transplants carried out today are due to a degenerative disease called keratoconus.

The University Hospital of New Jersey reports that the success rate for growth of new cells from transplanted stem cells varies from 25 percent to 70 percent.[51]

In 2014, researchers demonstrated that stem cells collected as biopsies from donor human corneas can prevent scar formation without provoking a rejection response in mice with corneal damage.[52]

In January 2012, The Lancet published a paper by Steven Schwartz, at UCLA's Jules Stein Eye Institute, reporting two women who had gone legally blind from macular degeneration had dramatic improvements in their vision after retinal injections of human embryonic stem cells.[53]

In June 2015, the Stem Cell Ophthalmology Treatment Study (SCOTS), the largest adult stem cell study in ophthalmology ( http://www.clinicaltrials.gov NCT # 01920867) published initial results on a patient with optic nerve disease who improved from 20/2000 to 20/40 following treatment with bone marrow derived stem cells.[54]

Diabetes patients lose the function of insulin-producing beta cells within the pancreas.[55] In recent experiments, scientists have been able to coax embryonic stem cell to turn into beta cells in the lab. In theory if the beta cell is transplanted successfully, they will be able to replace malfunctioning ones in a diabetic patient.[56]

Human embryonic stem cells may be grown in cell culture and stimulated to form insulin-producing cells that can be transplanted into the patient.

However, clinical success is highly dependent on the development of the following procedures:[11]

Clinical case reports in the treatment orthopaedic conditions have been reported. To date, the focus in the literature for musculoskeletal care appears to be on mesenchymal stem cells. Centeno et al. have published MRI evidence of increased cartilage and meniscus volume in individual human subjects.[57][58] The results of trials that include a large number of subjects, are yet to be published. However, a published safety study conducted in a group of 227 patients over a 3-4-year period shows adequate safety and minimal complications associated with mesenchymal cell transplantation.[59]

Wakitani has also published a small case series of nine defects in five knees involving surgical transplantation of mesenchymal stem cells with coverage of the treated chondral defects.[60]

Stem cells can also be used to stimulate the growth of human tissues. In an adult, wounded tissue is most often replaced by scar tissue, which is characterized in the skin by disorganized collagen structure, loss of hair follicles and irregular vascular structure. In the case of wounded fetal tissue, however, wounded tissue is replaced with normal tissue through the activity of stem cells.[61] A possible method for tissue regeneration in adults is to place adult stem cell "seeds" inside a tissue bed "soil" in a wound bed and allow the stem cells to stimulate differentiation in the tissue bed cells. This method elicits a regenerative response more similar to fetal wound-healing than adult scar tissue formation.[61] Researchers are still investigating different aspects of the "soil" tissue that are conducive to regeneration.[61]

Culture of human embryonic stem cells in mitotically inactivated porcine ovarian fibroblasts (POF) causes differentiation into germ cells (precursor cells of oocytes and spermatozoa), as evidenced by gene expression analysis.[62]

Human embryonic stem cells have been stimulated to form Spermatozoon-like cells, yet still slightly damaged or malformed.[63] It could potentially treat azoospermia.

In 2012, oogonial stem cells were isolated from adult mouse and human ovaries and demonstrated to be capable of forming mature oocytes.[64] These cells have the potential to treat infertility.

Destruction of the immune system by the HIV is driven by the loss of CD4+ T cells in the peripheral blood and lymphoid tissues. Viral entry into CD4+ cells is mediated by the interaction with a cellular chemokine receptor, the most common of which are CCR5 and CXCR4. Because subsequent viral replication requires cellular gene expression processes, activated CD4+ cells are the primary targets of productive HIV infection.[65] Recently scientists have been investigating an alternative approach to treating HIV-1/AIDS, based on the creation of a disease-resistant immune system through transplantation of autologous, gene-modified (HIV-1-resistant) hematopoietic stem and progenitor cells (GM-HSPC).[66]

On 23 January 2009, the US Food and Drug Administration gave clearance to Geron Corporation for the initiation of the first clinical trial of an embryonic stem-cell-based therapy on humans. The trial aimed evaluate the drug GRNOPC1, embryonic stem cell-derived oligodendrocyte progenitor cells, on patients with acute spinal cord injury. The trial was discontinued in November 2011 so that the company could focus on therapies in the "current environment of capital scarcity and uncertain economic conditions".[67] In 2013 biotechnology and regenerative medicine company BioTime (NYSEMKT:BTX) acquired Geron's stem cell assets in a stock transaction, with the aim of restarting the clinical trial.[68]

Scientists have reported that MSCs when transfused immediately within few hours post thawing may show reduced function or show decreased efficacy in treating diseases as compared to those MSCs which are in log phase of cell growth(fresh), so cryopreserved MSCs should be brought back into log phase of cell growth in invitro culture before these are administered for clinical trials or experimental therapies, re-culturing of MSCs will help in recovering from the shock the cells get during freezing and thawing. Various clinical trials on MSCs have failed which used cryopreserved product immediately post thaw as compared to those clinical trials which used fresh MSCs.[69]

There is widespread controversy over the use of human embryonic stem cells. This controversy primarily targets the techniques used to derive new embryonic stem cell lines, which often requires the destruction of the blastocyst. Opposition to the use of human embryonic stem cells in research is often based on philosophical, moral, or religious objections.[110] There is other stem cell research that does not involve the destruction of a human embryo, and such research involves adult stem cells, amniotic stem cells, and induced pluripotent stem cells.

Stem-cell research and treatment was practiced in the People's Republic of China. The Ministry of Health of the People's Republic of China has permitted the use of stem-cell therapy for conditions beyond those approved of in Western countries. The Western World has scrutinized China for its failed attempts to meet international documentation standards of these trials and procedures.[111]

State-funded companies based in the Shenzhen Hi-Tech Industrial Zone treat the symptoms of numerous disorders with adult stem-cell therapy. Development companies are currently focused on the treatment of neurodegenerative and cardiovascular disorders. The most radical successes of Chinese adult stem cell therapy have been in treating the brain. These therapies administer stem cells directly to the brain of patients with cerebral palsy, Alzheimer's, and brain injuries.[citation needed]

Since 2008 many universities, centers and doctors tried a diversity of methods; in Lebanon proliferation for stem cell therapy, in-vivo and in-vitro techniques were used, Thus this country is considered the launching place of the Regentime[112] procedure. http://www.researchgate.net/publication/281712114_Treatment_of_Long_Standing_Multiple_Sclerosis_with_Regentime_Stem_Cell_Technique The regenerative medicine also took place in Jordan and Egypt.[citation needed]

Stem-cell treatment is currently being practiced at a clinical level in Mexico. An International Health Department Permit (COFEPRIS) is required. Authorized centers are found in Tijuana, Guadalajara and Cancun. Currently undergoing the approval process is Los Cabos. This permit allows the use of stem cell.[citation needed]

In 2005, South Korean scientists claimed to have generated stem cells that were tailored to match the recipient. Each of the 11 new stem cell lines was developed using somatic cell nuclear transfer (SCNT) technology. The resultant cells were thought to match the genetic material of the recipient, thus suggesting minimal to no cell rejection.[113]

As of 2013, Thailand still considers Hematopoietic stem cell transplants as experimental. Kampon Sriwatanakul began with a clinical trial in October 2013 with 20 patients. 10 are going to receive stem-cell therapy for Type-2 diabetes and the other 10 will receive stem-cell therapy for emphysema. Chotinantakul's research is on Hematopoietic cells and their role for the hematopoietic system function in homeostasis and immune response.[114]

Today, Ukraine is permitted to perform clinical trials of stem-cell treatments (Order of the MH of Ukraine 630 "About carrying out clinical trials of stem cells", 2008) for the treatment of these pathologies: pancreatic necrosis, cirrhosis, hepatitis, burn disease, diabetes, multiple sclerosis, critical lower limb ischemia. The first medical institution granted the right to conduct clinical trials became the "Institute of Cell Therapy"(Kiev).

Other countries where doctors did stem cells research, trials, manipulation, storage, therapy: Brazil, Cyprus, Germany, Italy, Israel, Japan, Pakistan, Philippines, Russia, Switzerland, Turkey, United Kingdom, India, and many others.

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Stem-cell therapy - Wikipedia

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