Category Archives: Stem Cell Therapy

I expected to be diagnosed with breast cancer ever since my identical twin sister Karen started treatment for the disease seven years ago. It was only a matter of time. And while I wasnt happy to hear the words, I felt ready for the fightagain.

You see, Ive been diagnosed with cancer beforea rare, incurable blood cancer called multiple myeloma, and I wasnt expected to live more than three years. That was more than 20 years ago. Since then, Ive become a healthcare pro who shepherds patients through the system to find their cures. So when a small spot on one of my regular screenings turned out to be early stage breast cancer, I said to myself: Ive got this, its what I do. No problem.

But as I painfully re-learned with my second cancer diagnosis, cancer can be humbling. Even for a cancer expert. Even for someone who has been through this before.

When I first started battling cancer decades ago, I didnt know what I know now. But after years of research, difficult decisions and grueling treatmentsinduction therapy, chemo, stem cell transplant with my sister, maintenance therapy, relapse, infusions, side effectsI learned a fair amount about how to beat cancer. I also gained a great deal of hard-won wisdom about how the disease burdens friends and family along the way. Mine were there for me no matter how difficult the treatment, or the patient. And I could be difficult. No one knows that better than my sister.

Karen was my first call after being diagnosed with myeloma. She calmed me down when my test results were bad and bore my rage when I vented Why me? And then, when my myeloma became active and aggressive, she became my stem cell donor.

Then in 2014, eight years after giving me the life-saving gift of a stem cell transplant, Karen was diagnosed with breast cancer. Stage III. It was my turn to pay her back.

Together, we searched the internet, called every doctor and patient group, read every medical publication. Again, many decisions and years of debilitating treatments: surgery, chemo, radiation, and at least five years on therapy. Even today, she still warriors through the scans, the test results, the fear.

So how would I address my new diagnosis? I followed my tried-and true playbook, the one Id used with my sister and refined with an untold number of other patients: Google wisely, get a second opinion, find the right team, check your coverage, and always ask for the most current tests and treatments. My doctor laid out the options and encouraged me to speak with other doctors. One said low-dose tamoxifen. Another said lumpectomy, with treatment and/or radiation. Another said double mastectomy: You spent 20 years of your life trying to cure one disease; in one fell swoop you can cure this one. In the end I had all the data and science in the world. But no clear answer. The decision would be mine. The decision would be personal.

I reached out to family, to friends. My sister and I spoke endlessly about the toll of her ongoing treatment, from shortness of breath to the neuropathy that feels like shooting needles in her feet; having endured years of treatment issues myself for myeloma, I didnt know how many more I could bear, let alone more scans, more false positives, more biopsies. More restless nights and honest entries in my journal.

I spoke with friends about the burden I had put on them. On my husband, my children. Id been riding the cancer roller coaster for 25-plus years. I wanted off. And besides, having lived through a stem cell transplant, I figured double mastectomy would be easy (despite my doctors warning otherwise). Surgery on Tuesday, Moms birthday on Sunday, back to work on Monday. I put make-up on before surgery so I would look bright and healthy in a quick photo sent off to our children. This time I wouldnt burden anyone.

I was wrong. The surgery was harder than I imagined. I dont know how I could have managed without my friends to bring my favorite ginger tea, my kids to cook and walk the dog when I still couldnt hold the leash, my husband to drive me 90 minutes to each appointment, sit in with the doctor, and give me (very gentle) hugs when I needed them, and my sister to just agree it suckedno sense sugar-coating. And then there were the Zoom calls. Putting on my game face when I could barely reach for my lip gloss and concealer. Going into surgery I felt strong, in control. Coming out, I felt small. Full of doubts. Beaten up.

Sitting in her office a week later, I asked my doctor if Id made the right decision. Her response: There is no wrong answer, there is only the right answer for you.

After more than 25 years of curing my own cancer, and advising countless others how to cure theirs, heres what I know now about cancer:

My someones make me know I chose rightfor me. Thats what friends and family do. They are your sounding board to help you decide, and then they give unconditional support for that decision, and see you through no matter how hard the journey might be. Their comfort is your cure.

When facing cancer, even a cancer expert needs help.

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I've Been Diagnosed with Cancer TwiceThese Are the Lessons I've Learned - Prevention Magazine

Last Friday, the US FDA decided to keep the popular anti-baldness drug finasteride on the market, but is now requiring its makers to add suicidal ideation to a list of potential side effects.

Relatedly, on 13 June, the FDA also approved Eli Lillys and Incytes Olumiant (baricitinib), the first treatment for alopecia areata, another form of baldness, which also has a positive Committee for Medicinal Products for Human Use (CHMP) recommendation for an EMA approval. Alopecia areata is an autoimmune disorder when the bodys immune cells attack the hair follicles, while androgenic alopecia is a genetically determined pattern of hair loss.

These recent regulatory actions have brought attention to the hair loss space which has ample demand for treatments, but relatively few unique assets in development.

Though we are seeing new developments in the treatment of androgenetic alopecia (AGA) emerge in recent years, such as low dose oral minoxidil and bicalutamide, effective management remains challenging, writes Dr Dmitri Wall, consultant dermatologist at Hair Restoration Blackrock in Dublin, via email.

Marketed by Organon, a Merck spinoff, finasteride sold as Propecia had global sales of $292 million in 2005, as per GlobalData. The first generic was introduced in 2006. The FDAs most recent action came in response to a petition launched by a non-profit group called the Post-Finasteride Syndrome Foundation.

In 1988, the FDA approved minoxidil, a 2% topical solution then marketed by the company Upjohn under names such as Rogaine, for male use, before receiving approval for women in 1992. Several years later, a stronger 5% formula was approved for men in 1997, with a female version receiving the green light in 2014. Upjohn merged with the Swedish company Pharmacia AB in 1995, before being acquired by Pfizer in 2002.

Almost a decade after the initial approval of minoxidil, the FDA authorized the use of 1mg finasteride tablets in 1997, a dihydrotestosterone (DHT) blocker.

Finasteride is currently not approved for use by women and is contraindicated for pregnancy, as based on Propecias FDA label. However, there are cases of advised off-label use amongst postmenopausal and occasionally premenopausal women, says Eva Proudman, consultant trichologist and chair of the Institute of Trichologists.

Finasteride and minoxidil are used with roughly 80% of patients in Proudmans estimates, seeing a very positive result. While side effects do exist, she says her practice always discusses any safety concerns.

This isnt the first time finasterides potential side effects have received attention. In 2012, the FDA requested an update of the drugs label to include mention of risks of potential sexual dysfunction. According to Mercks label for Propecia, decreased libido and erectile dysfunction were reported in 1.8% and 1.3% of 945 treated subjects respectively. The latest suicidal ideation warning comes after internal records from Merck showed the company was aware of over 200 cases of depression since 2009, as described in a Reuters exclusive last February.

At the same time, it is important to note that hair loss can prove as a very emotional process for some and there are more factors surrounding potential depression or suicidal ideation than just in case of finasteride use, says Proudman. As such, understanding what these treatments can potentially do is needed, she adds.

Moreover, some studies show that the topical treatment minoxidil is also potentially not for everyone. In a Pfizer-sponsored one-year observational study of minoxidils 5% solution from 2004, the treatment shrunk the targeted hair-loss area in 62% of subjects, but it remained unchanged in 35.1%. In the same study, 15.9% of the subjects rated the treatment as very effective, but 20.6% found it only moderately effective and 15.7% found no effects. The topical solution is intended for use in the crown and is not aimed for the treatment of frontal baldness or a receding hairline, as based on Rogaines label.

Dutasteride, another DHT blocker sold by GSK under the name Avodart, has also displayed efficacy in reducing hair loss. But the treatment has not yet been approved by the FDA for the treatment of androgenic alopecia, despite off label use.

Outside of these two established treatments, cosmetic procedures such as scalp micropigmentation, scalp reduction or hair transplantation are becoming increasingly prominent. We continue to await the delivery of safe and effective stem-cell therapy that has promised much, while limited evidence regarding adjuvant therapies such as platelet rich plasma (PRP) and low-level laser therapy (LLLT) is yet to convincingly prove their benefit, says Wall, who is also an assistant professor at the Charles Institute of Dermatology at University College Dublin.

According to GlobalDatas Pharma Intelligence Centre, there are currently 20 assets in development for androgenic alopecia. This ranges from minoxidil that is in pre-registration in Taiwan, to IVL3001, a month-lasting injection of finasteride made by the South Korean company Inventage Lab, and treatments previously unused within the space such as Cosmo Pharmaceuticals topical solution Breezula (clascosterone).

Other approaches include antiandrogens such as GT-20029 or KX-826 (pyrilutamide), developed by the Chinese pharma company Kintor Pharmaceuticals. Pyrilutamide is currently in two Phase II studies, with one for male androgenic alopecia subjects in the US, and the other for female subjects in China.

At the same time, Proudman stresses the need for efficacious products, rather than those with promises. In June 2021, the Swedish company Follicum announced its discontinuing a Phase IIa hair loss treatment FOL-005 after an independent review led to revised data showing no significant improvement.

In this sense, Proudman says it is likely that upcoming treatments will be similar to those in the available armamentarium.

"Even with the emergence of novel therapies, it remains most likely that optimal, sustained responses will require combination therapy that should be chosen after consideration of individual factors," notes Wall.

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Alopecia: Are there any new treatments on the horizon? - Pharmaceutical Technology

The global stem cell therapy market is estimated to be over US$ 23.7 Bn by 2030 . It is anticipated to grow at a CAGR of 11.2 % from 2022 to 2030.

Stem Cell Therapy Market by Vendor Assessment, Technology Assessment, Partner & Customer Ecosystem, type/solution, service, organization size, end-use verticals, and Region Global Stem Cell Therapy Market Forecast to 2030, published by Market Data Centre, The Stem Cell Therapy Market is projected to grow at a solid pace during the forecast period. The presence of key players in the ecosystem has led to a compsetitive and diverse market. The advancement of digital transformation initiatives across multiple industries is expected to drive the worldwide Stem Cell Therapy Market during the study period.

This COVID-19 analysis of the report includes COVID-19 IMPACT on the production and, demand, supply chain. This report provides a detailed historical analysis of the global Stem Cell Therapy Market from 2017-to 2021 and provides extensive market forecasts from 2022-to 2030 by region/country and subsectors. The report covers the revenue, sales volume, price, historical growth, and future perspectives in the Stem Cell Therapy Market.

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Regional Analysis:

On the basis of Geography, the Global Stem Cell Therapy Market is segmented into North America, Europe, Asia-Pacific, and the Rest of the World (RoW). North America is expected to hold a considerable share in the global Stem Cell Therapy Market. Due to increasing investment for research and development process and adoption of solutions in the region whereas Asia-Pacific is expected to grow at a faster pace during the forecasted period.

The growing number of Stem Cell Therapy Market players across regions is expected to drive market growth further. Moreover, increasing investments by prominent vendors in product capabilities and business expansion is expected to fuel the market during the study period. Many market players are finding lucrative opportunities in emerging economies like China and India, where the large populations are coupled with new innovations in numerous industries.

In deep ToC includes

233 Tables

45 Figures

300 Pages

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Table of Contents

ToC can be modified as per clients business requirements*

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Key Questions Answered in This Report:

Vendor Assessment

Vendor assessment includes a deep analysis of how vendors are addressing the demand in the Stem Cell Therapy Market. The MDC CompetetiveScape model was used to assess qualitative and quantitative insights in this assessment. MDCs CompetitiveScape is a structured method for identifying key players and outlining their strengths, relevant characteristics, and outreach strategy. MDCs CompetitiveScape allows organizations to analyze the environmental factors that influence their business, set goals, and identify new marketing strategies. MDC Research analysts conduct a thorough investigation of vendors solutions, services, programs, marketing, organization size, geographic focus, type of organization and strategies.

Technology Assessment

Technology dramatically impacts business productivity, growth and efficiency.Technologies can help companies develop competitive advantages, but choosing them can be one of the most demanding decisions for businesses. Technology assessment helps organizations to understand their current situation with respect to technology and offer a roadmap where they might want to go and scale their business. A well-defined process to assess and select technology solutions can help organizations reduce risk, achieve objectives, identify the problem, and solve it in the right way. Technology assessment can help businesses identify which technologies to invest in, meet industry standards, compete against competitors.

Business Ecosystem Analysis

Advancements in technology and digitalization have changed the way companies do business; the concept of a business ecosystem helps businesses understand how to thrive in this changing environment. Business ecosystems provide organizations with opportunities to integrate technology in their daily business operations and improve research and business competency. The business ecosystem includes a network of interlinked companies that compete and cooperate to increase sales, improve profitability, and succeed in their markets. An ecosystem analysis is a business network analysis that includes the relationships amongst suppliers, distributors, and end-users in delivering a product or service.

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Regions and Countries Covered

North America (US, Canada), Europe (Germany, UK, France, Spain, Italy, and Rest of Europe), Asia-Pacific (Japan, China, Australia, India, Rest of Asia-Pacific), and Rest of the World (RoW).

Report Coverage

Stem Cell Therapy Market Dynamics, Covid-19 Impact on the Stem Cell Therapy Market, Vendor Profiles, Vendor Assessment, Strategies, Technology Assessment, Product Mapping, Industry Outlook, Economic Analysis, Segmental Analysis, Stem Cell Therapy Market Sizing, Analysis Tables.

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Stem Cell Therapy Market | Exclusive Trends Analysis with Forecast to 2030 - Digital Journal

Blocking the mutant protein with an antibody didnt stop the strange, abnormal bone growths in mice. But the knowledge gained could steer scientists toward more promising approaches, report researchers from UConn and Alexion Pharmaceuticals in the 15 June issue of The Journal of Clinical Investigation.

Fewer than 4,000 people worldwide are afflicted with fibrodysplasia ossificans progressiva (FOP), an inherited disease in which small injuries or bruises to skeletal muscle provoke the growth of massive, abnormal bone and cartilage. Gradually much of the bodys soft tissue turns to bone. Now, researchers at UConn and Alexion Pharmaceuticals who were investigating a potential cure instead found a concerning surpriseblocking the protein responsible for the disease with a monoclonal antibody made the abnormal bone growth worse in mice .

Normally, stem cells help repair muscle damaged by injury or disease. But in people with FOP, certain stem cells get the wrong message from a mutant receptor on their surface. Instead of promoting muscle regeneration, the stem cells develop into bone.

UConn Professor of Molecular and Cell Biology David Goldhamer, Alexion Pharmaceuticals researcher Jeffrey Hunter, and colleagues worked for years to discover a potential antibody therapy for FOP using accurate genetic mouse models of the disease developed by the two groups. The idea was that the antibody would block the mutant receptor and prevent the responsible stem cells from making new bone. But the results were exactly the opposite.

The unexpected result: injecting the antibody into FOP mice caused a dramatic increase in inappropriate bone formation, instead of protecting them as wed hoped, Goldhamer says.

Goldhamer, Hunter and their teams worked with an antibody discovered by Alexion that interferes with the specific cell-surface receptor involved in FOP called Activin A receptor type 1, or ACVR1. The researchers thought that if they blocked ACVR1, the abnormal bone growth would stop. But instead, it was exacerbated.

The antibody appears to lower the injury threshold needed to stimulate bone growth within muscle tissue. Mild injuries that normally dont make bone in FOP mice suddenly make lots of bone. Additionally, the antibody increases and prolongs the immune response to the injury, Goldhamer says.

Another team working on antibody-based therapies for FOP ran into the same effect. Regeneron Pharmaceuticals used different antibodies they derived independently, as well as a different strain of FOP mice, but got the same adverse result. Their paper also appears in the JCI this week.

The teams dont yet know precisely why the antibodies dramatically worsen the disease in mice, but their work raises serious safety and efficacy concerns for the clinical application of this approach, which has not yet been tested in humans. Neither team has plans to pursue this clinically.

This work was funded by a grant from the National Institutes of Health (R01AR072052) and a sponsored research agreement between Alexion Pharmaceuticals and the University of Connecticut.

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An Experimental Treatment Failed in Mice, and Researchers Did the Right Thing: They Published About It - UConn Today - UConn

First Site Will Enroll First Patient in the Clinical Study

MELVILLE, NY., June 13, 2022 (GLOBE NEWSWIRE) BioRestorative Therapies, Inc. (the Company or BioRestorative) (NASDAQ: BRTX),a clinical stage company focused on stem cell-based therapies, today announced site initiation for its Phase 2 clinical trial targeting chronic lumbar disc disease (cLDD). The Denver Spine and Pain Institute is the first clinical site to be initiated. Additional selected sites are expected to be initiated in 2022.

BioRestoratives Phase 2 trial is a double-blind controlled, randomized study to evaluate the safety and preliminary efficacy of a single dose intradiscal injection of the Companys autologous investigational stem cell-based therapeutic, BRTX-100. A total of up to 99 eligible patients will be randomized at up to 15 centers in the United States to receive either the investigational drug (BRTX-100) or control in a 2:1 fashion.

Currently there are no approved, cell-based therapies for cLDD. While there is encouraging data that suggests that patients with cLDD could benefit from autologous stem cell transplants, the low oxygen micro-environment of the disc makes cell-based therapies challenging. BRTX-100 is manufactured under low oxygen conditions and engineered to survive this environment, said Scott Bainbridge, M.D., Principal Investigator for the BRTX-100 trial at The Denver Spine and Pain Institute. Positive proof-of-concept data in this trial could be disruptive and support the potential applicability of BRTX-100 to other spine and musculoskeletal disorders where low oxygen micro-environments are found.

We are pleased to initiate the first of several sites across the United States that will be enrolling for the trial, said Lance Alstodt, Chief Executive Officer of BioRestorative Therapies. Our sites have been carefully reviewed and selected and have clinical expertise in treating patients who could potentially benefit from BRTX-100. We look forward to working with the principal investigators and their clinical trial teams.

About BioRestorative Therapies, Inc.

BioRestorative Therapies, Inc. (www.biorestorative.com) develops therapeutic products using cell and tissue protocols, primarily involving adult stem cells. Our two core programs, as described below, relate to the treatment of disc/spine disease and metabolic disorders:

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. You are cautioned that such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events or results to differ materially from those projected in the forward-looking statements as a result of various factors and other risks, including, without limitation, those set forth in the Companys latest Form 10-K filed with the Securities and Exchange Commission and other public filings. You should consider these factors in evaluating the forward-looking statements included herein, and not place undue reliance on such statements. The forward-looking statements in this release are made as of the date hereof and the Company undertakes no obligation to update such statements.

CONTACT:Email:ir@biorestorative.com

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BioRestorative Therapies Announces Clinical Site Initiation for the Company's Phase 2 Clinical Trial to Treat Chronic Lumbar Disc Disease (cLDD) -...

World Sickle Cell Day 2022:

Bangalore, June 16, 2022: There are as many as 2.5 million carrier of the gene (Hemoglobin AS) in India that can lead to sickle cell disease, with more than 1,25,000 actual patients spread across the country, with a much higher incidence in the tribal belt of the country. Sickle cell disease is associated with a significant risk of morbidity and premature mortality, especially among children. While in the west, a child receiving comprehensive care in high-resource settings has an estimated 99% survival into adulthood. However, in India, according to an ICMR study, about 20 per cent of children with sickle disease died by the age of two, and 30 per cent children with Sickle Cell Disease die before they reach adulthood.

Dr. Biju George, Professor & Head, Department of Haematology at CMC Vellore, People with Sickle Cell Disease, may beat a risk of progressive organ damage, impaired quality of life, considerable morbidity in childhood, and risk of premature mortality in adulthood [median survival of 58 years]. Sickle Cell disease patients who are undergoing regular life-long blood transfusions, have the best chance of survival and cure with a blood stem cell transplant. This transplant can come from a sibling or a family member. However, there is only a 30% chance of finding a matched sibling donor in the same family. The remaining 70% patients look for a matching donor through a stem cell registry or donor center- a database of voluntary donors between the age group of 18 to 50 years.

Dr. Govind Eriat Nair, Consultant Hematology Hemato-Oncology and Bone Marrow Transplant Gleneagles Global BGS Hospital, Bengaluru, If there is a fully HLA matched donor in the family, there is a 90-95% chance of cure with higher cure rates in younger children of below 12 years of age. However, due to underrepresentation of Indians in the global donor data pool, patients are unable to find a match on time. Also, the awareness about the disease is less, need of the hour is to raise the social awareness about this disease. Genetic counseling and newborn screening are the way forward. Effects of endogamy, consanguinity and role prenatal counseling needs to be addressed in primary screening.

DKMS BMST Foundation India is a non-profit organization dedicated to the fight against blood cancer and other blood disorders, such as thalassemia and sickle cell disease. The organization aims to give every blood disorder patient in need a second chance at life.

To mark World Sickle Cell Day, Patrick Paul, CEO, DKMS BMST Foundation India said, Sickle cell has variance and only the severe form needs a stem cell transplant. An early transplant can help patient with severe Sickle cell disease from organ damage. With rising cases in India, it is the need of the hour that stem cell transplants are made available to more patients to save lives. But due to the misconceptions and lack of awareness about blood stem cell donation, Indians are highly underrepresented in the global donor pool. This situation can only be changed by recruiting many more potential blood stem cell donors from the Indian ethnicity.

The success of a stem cell transplant depends of donors HLA (Human Leukocyte Antigen) matching the patient. The bodys immune system has proteins known as HLA to distinguish cells that belong to the body from those that do not. DKMS-BMST helps in unrelated donor transplant process which includes enrolling and counselling the donors, get their HLA typing done, facilitate search of the donors and later facilitate the blood stem cell collection and the transplant. So, far DKMS-BMST has registered over 60,000 potential donors and have helped 60 patients with second chance at life.

Register as a potential blood stem cell donor:

Healthy individuals between 18-50 years of age can register at: dkms-bmst.org/register

All it takes is five minutes of your time and a simple 3 step process:

Step 1: Visit the site, fill up an online form and you will receive a DIY swab kit at home.

Step 2: Once you receive the swab kit, fill out the consent form and take a tissue sample from the inside of your cheeks with 3 cotton swabs provided in the kit.

Step 3: Send back your swab sample in the pre-paid envelope provided.

DKMS laboratory will then analyze your tissue type and your details will be available in the global search for blood stem cell donors. If you do come up as a suitable donor, DKMS-BMST will get in touch with you straight away. Once you come up as a match, blood stem cells will be obtained from the bloodstream using a procedure called Peripheral Blood Stem Cell Collection, which is similar to a blood donation wherein only your stem cells are taken. This is a safe, non-surgical outpatient procedure.

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Stem Cell Transplant the only curative treatment for Sickle cell Disease - NewsPatrolling