Category Archives: Stem Cell Therapy

Development of advanced genomic analysis techniques, the introduction of effective guidelines for cell therapy manufacturing, a vast amount of research by cancer societies, and the proven effectiveness of transplants are some of the primary growth stimulants for the market. Certain manufacturing and pharmacological issues and regulatory hurdles are hindering the growth of the market.

The report offers an industry-wide and economy-wide analysis of the market along with supply and demand dynamics, sales, and production and manufacturing capacity. It also reviews the rate of production and consumption, sales network and distribution channel, pricing analysis, profit margins, cost and demand volatility, import/export, gross revenue, among others. Financial difficulties brought by the pandemic have slowed down the progression of the businesses, and disruptions in the supply chains have been seen. The report assesses the comprehensive impact of the pandemic on the overall growth of the Stem Cell Therapy market and offers a future impact assessment.

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COVID Analysis

The research report draws focus on the impact of the COVID-19 pandemic on the market and its crucial segments. It offers insights into the effects of the pandemic on the global economic scenario and business sphere. The report evaluates the key market influencing factors and considers the COVID-19 pandemic as one of the contributing elements.

With a major focus on the growth trajectories of each segment of the market, the report inspects the operating patterns of each market contender, for instance, partnerships & collaborations, mergers & acquisitions, and new product launches, in a detailed manner.

The Stem Cell Therapy market intelligence report exhaustively examines the market value, share, demand, growth prospects, latest and historical trends, manufacturers, gross revenue collection, competitive terrain, market growth forecast, available products, and end-use applications.

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Read more from the original source:
Stem Cell Therapy Market Trend, Forecast, Drivers, Restraints, Company Profiles and Key Players Analysis by 2027 The Manomet Current - The Manomet...

Report Introduction

The report entitled, Global Stem Cell Therapy Market is a unique market study that offers the latest in-depth information and comprehensive analysis of the market. It provides a complete overview of the market with detailed insights on key aspects including the current market situation, potential size, volume, and dynamics of the market. This research report makes a thorough assessment of the COVID-19 pandemic and its impact on the current market and evaluates the possible outcome of the market during the forecast period, 2021 2028.

Competitors Landscape

Key players in the market include

Osiris TherapeuticsNuVasiveChiesi PharmaceuticalsJCR PharmaceuticalPharmicellMedi-postAnterogenMolmedTakeda (TiGenix)Stem Cell Therap

This report offers a comprehensive view regarding the competitive landscape of the Stem Cell Therapy market and includes a broad description of performance by some of the key global players completing in the market. It offers a list of latest updates of several business strategies including mergers, acquisitions, partnerships, product launch, expansion of production units, and collaborations adopted by these major global players. The report provides a clear picture regarding R&D investment from key players and adoption of innovative technologies to widen their consumer base and expand the existing competitive position. Moreover, the report offers a detailed information about the position, scope of growth, and opportunities of new entrants or players in the market.

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Keeping a view to grasp the overall prospect of the market, the report explains key drivers, opportunities, restraints, and challenges focusing on the current market trend and evaluates the prospects of the future market. The report offers an extensive study of the market segments and sub-segments with a clear explanation of which segment is expected to dominate the market during the forecast period.

To assist clients in arriving informed decision about their business investment plans and strategies of the market, the report provides a broad information about the performance of regional markets and competitors analysis. The report analyses the latest development and profiles of the major global players competing in the market to understand their positions and expansion capacity.

Segments Insight

The global Stem Cell Therapy market is divided into

AutologousAllogeneicStem Cell Therap

The report includes key insights regarding segments and sub-segments of the market. It covers a detailed information regarding the performance and market valuation of each segment along with the expected CAGR including various sub-segments of the market during the forecast period. Additionally, the report offers insight about key driving factors that help to expand the segment as well as major challenges that can hamper the growth of segments during the projected period to understand the clear picture of the overall expansion scope of the market.

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Applications

The global Stem Cell Therapy market is categorized into

Musculoskeletal DisorderWounds & InjuriesCorneaCardiovascular DiseasesOthers

The report lists a wide range of applications of Stem Cell Therapy and covers the major industries that extensively use the product for their various applications. A detailed explanation is provided in the report about the areas of applications describing where the product is adopted by key industries to leverage their business portfolio. It also provides information about factors that help expand market scope of some of the key applications, their revenue share of each application, and their segment parameters to grasp a complete sense of the segment.

Regional Analysis

The global Stem Cell Therapy market is classified as

Asia Pacific

Europe

North America

Latin America

Middle East & Africa

This research report widely covers the revenue share, potential growth opportunities, and projected growth rate focusing on five major regions namely Asia Pacific, Europe, North America, Latin America, and Middle East & Africa. Additionally, the report includes a broad analysis of which sub-regions and countries within a region, which are expected to dominate the regional market during the forecast period. The report provides vital information regarding socio-economic and political factors that can influence the overall performance and growth rate of the respective regional markets. A special chapter is reserved in the report for the COVID-19 pandemic and its impacts on the regional market and further explains how this pandemic is projected to influence consumers behavior of the Stem Cell Therapy market in the coming years. The report also focuses on elaborating the roles and impacts of the existing regional trade regulations and government policies & regulations that can either boost or hinder the regional market expansion.

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Some Major TOC Points:

Chapter 1. Report Overview

Chapter 2. Global Growth Trends

Chapter 3. Market Share by Key Players

Chapter 4. Breakdown Data by Type and Application

Chapter 5. Market by End Users/Application

Chapter 6. COVID-19 Outbreak: Stem Cell Therapy Industry Impact

Chapter 7. Opportunity Analysis in Covid-19 Crisis

Chapter 8. Market Driving Force

And Many More

Reasons to Buy the Report

Contact Info: Name: Alex MathewsAddress: 500 East E Street, Ontario,CA 91764, United States.Phone No: USA: +1 909 414 1393Email: [emailprotected]Website: https://industrygrowthinsights.com

Link:
Stem Cell Therapy Industry 2021 Insights. A Detailed Research Report Covering Osiris Therapeutics, NuVasive, Chiesi Pharmaceuticals, JCR...

REGULATED INFORMATION

Strong clinical progress especially in JTA-004 Phase III study thanks to high patient compliance and retention

Process development partnership and appointment of cell therapy expert Anthony Ting as CSO to further strengthen product pipeline

Gosselies, Belgium, 26May 2021, 7am CEST BONE THERAPEUTICS (Euronext Brussels and Paris: BOTHE), the cell therapy company addressing unmet medical needs in orthopedics and other diseases, today announces its business update for the first quarter, ended 31 March 2021.

Bone Therapeutics has continued the strong momentum into 2021, said Miguel Forte, MD, PhD, CEO of Bone Therapeutics. Bone Therapeutics mid-late stage clinical programs continue to advance largely on schedule, including the Phase IIb trial of the allogenic cell therapy platform ALLOB in difficult-to-heal tibial fractures and the Phase III trial of the enhanced viscosupplement JTA-004 in knee osteoarthritic pain. Alongside this, Bone Therapeutics has strengthened its manufacturing and R&D capabilities by signing a process development partnership with Rigenerand. It has also appointed the industry veteran Tony Ting as our new Chief Scientific Officer. Building on these achievements, Bone Therapeutics will be able to continue significant clinical and commercial advancements as we move towards the topline data of our JTA-004 Phase III study; a potential key inflection point for Bone Therapeutics.

Operational highlights

Financial highlights

Outlook for the remainder of 2021

(1) Unaudited number

About Bone Therapeutics

Bone Therapeutics is a leading biotech company focused on the development of innovative products to address high unmet needs in orthopedics and other diseases. The Company has a, diversified portfolio of cell and biologic therapies at different stages ranging from pre-clinical programs in immunomodulation to mid-to-late stage clinical development for orthopedic conditions, targeting markets with large unmet medical needs and limited innovation.

Bone Therapeutics is developing an off-the-shelf next-generation improved viscosupplement, JTA-004, which is currently in Phase III development for the treatment of pain in knee osteoarthritis. Consisting of a unique combination of plasma proteins, hyaluronic acid - a natural component of knee synovial fluid, and a fast-acting analgesic, JTA-004 intends to provide added lubrication and protection to the cartilage of the arthritic joint and to alleviate osteoarthritic pain and inflammation. Positive Phase IIb efficacy results in patients with knee osteoarthritis showed a statistically significant improvement in pain relief compared to a leading viscosupplement.

Bone Therapeutics core technology is based on its cutting-edge allogeneic cell therapy platform with differentiated bone marrow sourced Mesenchymal Stromal Cells (MSCs) which can be stored at the point of use in the hospital. Currently in pre-clinical development, BT-20, the most recent product candidate from this technology, targets inflammatory conditions, while the leading investigational medicinal product, ALLOB, represents a unique, proprietary approach to bone regeneration, which turns undifferentiated stromal cells from healthy donors into bone-forming cells. These cells are produced via the Bone Therapeutics scalable manufacturing process. Following the CTA approval by regulatory authorities in Europe, the Company has initiated patient recruitment for the Phase IIb clinical trial with ALLOB in patients with difficult tibial fractures, using its optimized production process. ALLOB continues to be evaluated for other orthopedic indications including spinal fusion, osteotomy, maxillofacial and dental.

Bone Therapeutics cell therapy products are manufactured to the highest GMP (Good Manufacturing Practices) standards and are protected by a broad IP (Intellectual Property) portfolio covering ten patent families as well as knowhow. The Company is based in the BioPark in Gosselies, Belgium. Further information is available at http://www.bonetherapeutics.com.

For further information, please contact:

Bone Therapeutics SAMiguel Forte, MD, PhD, Chief Executive OfficerJean-Luc Vandebroek, Chief Financial OfficerTel: +32 (0)71 12 10 00investorrelations@bonetherapeutics.com

For Belgian Media and Investor Enquiries:BepublicCatherine HaquenneTel: +32 (0)497 75 63 56catherine@bepublic.be

International Media Enquiries:Image Box CommunicationsNeil Hunter / Michelle BoxallTel: +44 (0)20 8943 4685neil.hunter@ibcomms.agency / michelle@ibcomms.agency

For French Media and Investor Enquiries:NewCap Investor Relations & Financial CommunicationsPierre Laurent, Louis-Victor Delouvrier and Arthur RouillTel: +33 (0)1 44 71 94 94bone@newcap.eu

Certain statements, beliefs and opinions in this press release are forward-looking, which reflect the Company or, as appropriate, the Company directors current expectations and projections about future events. By their nature, forward-looking statements involve a number of risks, uncertainties and assumptions that could cause actual results or events to differ materially from those expressed or implied by the forward-looking statements. These risks, uncertainties and assumptions could adversely affect the outcome and financial effects of the plans and events described herein. A multitude of factors including, but not limited to, changes in demand, competition and technology, can cause actual events, performance or results to differ significantly from any anticipated development. Forward looking statements contained in this press release regarding past trends or activities should not be taken as a representation that such trends or activities will continue in the future. As a result, the Company expressly disclaims any obligation or undertaking to release any update or revisions to any forward-looking statements in this press release as a result of any change in expectations or any change in events, conditions, assumptions or circumstances on which these forward-looking statements are based. Neither the Company nor its advisers or representatives nor any of its subsidiary undertakings or any such persons officers or employees guarantees that the assumptions underlying such forward-looking statements are free from errors nor does either accept any responsibility for the future accuracy of the forward-looking statements contained in this press release or the actual occurrence of the forecasted developments. You should not place undue reliance on forward-looking statements, which speak only as of the date of this press release.

Read more from the original source:
Bone Therapeutics Provides First Quarter 2021 Business Update - GlobeNewswire

A stem cell research project headed up by Aston University is developing 3D nanoprinting techniques that they claim could revolutionize neuroscience and the treatment of diseases such as Parkinsons and dementia.

The EU-funded Meso-Brain project aims to generate customizable 3D printed networks of stem-cell-derived neurons to produce a new generation of accurate modeling and testing tools.

The project hopes to address the limitations of current neuronal culturing techniques by combining cutting-edge research within human stem cell biology, nanoscale 3D printing, computational network modeling and light sheet microscopy to discover novel treatment options for the long-term alleviation of brain dysfunction.

Meso-Brain hopes to unlock meaningful and practicable insights into the functioning of the brain, and will eventually allow researchers to accurately model brain networks more realistically than ever before.

Cell 3D printing

Stem cells generally serve as a repair system for the body, and, being unspecialized, are able to develop into a variety of different types of cells. As such, stem cells can develop into specialized cells such as blood, muscle, and brain cells, when required.

Cell 3D printing is an area that is receiving growing interest from researchers and 3D printing firms alike as a means of harnessing these desirable properties, particularly for regenerative medicine and bioprinting applications.

For instance, 3D printer OEM 3D systems announced a breakthrough in its Print to Perfusion bioprinting platform earlier this year, which can now rapidly produce full-size human lung scaffolds that can be perfused with living cells to create tissues. Meanwhile, scientists at the University of Buffalo have developed a new 3D bioprinting method that reduces the time needed to create cell-laden hydrogel structures, potentially bringing 3D printed organs closer to reality.

Elsewhere, researchers from the University of New South Wales have developed a novel technique to 3D print bone-mimicking structures containing living cells with potential uses for bone tissue engineering and disease modeling, and a new bioink created by Lund University is capable of supporting new cell and blood vessel growth once transplanted into new material.

In a similar vein to the Meso-Brain project, 3D bioprinting has previously been deployed by medical tech company Fluicell, R&D firm Cellectricon, and the Karolinska Institutet university to arrange neural brain cells into complex patterns in order to model the progress of neurological diseases.

The Meso-Brain project

The project was first launched by Aston University in 2016 with the goal of using nanoscale 3D printing to replicate the brains neural networks. The project has since received further funding from the EUs Horizon 2020 FET-Open program to accelerate the pace of neuroscience research and pharmaceutical drug discovery.

Coordinated by Aston University, the project is made up of six partners from three countries, including human cell culture specialist Axol Bioscience, digital service provider Kite Innovation, the Institute of Photonic Sciences (ICFO), the University of Barcelona, and LZH Laser Zentrum Hannover E.V.

Meso-Brain combines revolutionary tools for micro-fabrication, neuronal network development and monitoring, and functional analysis to bring to light 3D human neuronal networks with tailored characteristics.

Through Meso-Brain, the consortium is working on developing a new type of neural culture and interacting interface system integrated with conductive polymers, that will facilitate electrical stimulation and recording of individual cells.

In naturally developing circuits in the brain, neurons and connections are first generally configured and then gradually refined over time in response to chemical and electrical activity. To replicate this process in the researchers own 3D printed scaffolds, neurons and astrocytes derived from stem cells are developed at specific cytophilic points through the use of chemical messages and electrical activity to promote and drive functional network development.

After this process, functional connectivity maps are drawn using newly-developed mathematical formulations to verify the function of the 3D printed neural network structure.

The customizable properties of the 3D printed scaffolds enable fluorescence imaging and interrogation with photonic and optical approaches, therefore making it possible to see how the neurons interact with each other in real-time.

Future impacts of Meso-Brain

It is hoped that the research developments within Meso-Brain will allow researchers to accurately and dynamically model brain networks to identify neurons in various states of dysfunction and test their reaction to new medicines and other treatments.

According to the project partners, the development of human 3D neuronal networks that exhibit physiologically relevant and reproducible architecture and activity could be foundational to the scientific community, enabling large-scale scientific investigation of human brain network function.

The projects results also hope to facilitate large-scale pharmaceutical testing on human cells and human disease models with stem cells derived from patients, eventually leading to advances in neural transplantations for central nervous system therapy and repair.

Ultimately, the researchers believe Meso-Brain can aid the understanding and treatment of a range of neurological conditions such as dementia, Parkinsons, and brain trauma.

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Featured image shows a CT brain scan of a cranium with TBI. Image via Qrons.

Read more here:
Meso-Brain project explores 3D printed stem cells to treat neurological conditions - 3D Printing Industry

bluebird bios cerebral adrenoleukodystrophy (CALD) gene therapy Skysona has moved closer towards EU approval after gaining a positive opinion from the European Medicines Agencys Committee for Medicinal Products for Human Use (CHMP).

The CHMP has recommended marketing authorisation for Skysona (elivaldogene autotemcel, Lenti-D) for the early treatment of CALD in patients under 18 years old with an ABCD1 genetic mutations, and who do not have a matched sibling haematopoietic stem cell (HSC) donor.

bluebird bio's Skysona is a potential one-time gene therapy designed to add functional copies of the ABCD1 gene into a patients hematopoietic stem cells.

Once this functional gene is added to a CALD patients stem cells, the patient's body can produce the adrenoleukodystrophy protein (ALDP), which is believed to allow for the breakdown of very-long-chain fatty acids that build up to toxic levels in the brain.

CALD is a progressive and fatal neurodegenerative disease that overwhelmingly affects males. It involves the breakdown of myelin the protective sheath of nerve cells in the brain that is responsible for muscle control and thinking.

The condition is caused by mutations in the ABCD1 gene that affect the production of ALDP which eventually causes damage to the adrenal cortex and white matter of the brain and spinal cord.

Currently, the only treatment for the disease is a stem cell transplant, although this carries a significant risk from the high-dose chemotherapy used to prepare patients for the procedure.

Other complications include graft-versus-host (GvHD) disease, which occurs when the transplanted cells recognise the recipients cells as foreign and attack them.

In the phase 2/3 Starbeam study evaluating Skysona, 90% of CALD patients met the month 24 major functional disability- (MFD) free survival endpoint as of the last data cutoff date.

MFDs are the six severe disabilities commonly attributed to CALD, which have the most severe effect on a patients ability to function independently.

In addition, 26 out of 28 evaluable patients maintained a neurologic function score (NFS) less than or equal to one until month 24, with 24 of those patients having no change in their NFS.

The CHMPs positive opinion is now due to be reviewed by the European Commission, with a final decision for Skysona expected in mid-2021.

See the rest here:
bluebird bio's CALD gene therapy Skysona gains positive opinion from CHMP - PMLiVE

SAN DIEGO, May 24, 2021 /PRNewswire/ -- Stemedica Cell Technologies, Inc. ("Stemedica"), a San Diego-based biotech company specializing in the manufacture of clinical grade stem cells, announced today that it has signed a Licensing Agreement with Pulthera, LLC for the rights to use, distribute and sell its mesenchymal stem cell technologies in the treatment of COVID-19 and additional pulmonary conditions.

The agreement was confirmed today by Roger Howe PhD, Chairman and CEO of Stemedica. "We are pleased to announce this licensing agreement with Pulthera. Their team's clinical, fundraising and business development experience will help Stemedica advance our best-in-class stem cell technology to treat those with medical conditions resulting from COVID-19 or other pulmonary indications targeted by Pulthera."

Pulthera, a Delaware Incorporated Limited Liability Corporation, was formed for the express purpose of advancing medical solutions for those suffering from respiratory conditions including both acute and chronic forms of COVID-19. The company is led by Founder and Chairman David R. Grieve, a successful business development entrepreneur.

"When I heard of the significant results Stemedica's mesenchymal stem cells had in their 2020 COVID-19 Proof of Concept Clinical Trial, I wanted to team up with them and help bring the potential of their products to others suffering from respiratory medical indications for which there are limited or no treatment options," said David Grieve. "Since my first discussions with Stemedica, I have become more and more convinced that there is a serious, growing need for a therapeutic solution for those already impacted by having had COVID-19."

Stemedica's Proof of Concept Clinical Trial involved fourteen critically ill COVID-19 patients who were treated on Emergency Use and Expanded Use INDs at the Providence Saint John's Health Center (Santa Monica, CA) and ProMedica (Toledo, OH). The stem cell treatment resulted in an improved clinical course for the patients. The study found improved inflammatory modulation, and 88 percent of patients had a significant reduction in acute phase reactants (markers for reductions in inflammation) which resulted in a reduced "cytokine storm." Researchers noted that these patients experienced quicker extubation, less lung trauma and less oxygen toxicity. Stemedica went on to receive U.S. FDA approval for a Phase Ila clinical trial for patients with moderate to severe lung injury due to COVID-19 or other potential viral and bacterial pathogens.

Supporting David Grieve in developing clinically successful and commercially viable pathways for Pulthera is James Snider, who will serve as the Company's CEO. Mr. Snider is Pharma industry executive with over thirty-five years of experience, including professional positions at Novo Nordisk, Bioverativ and Sanofi Genzyme. "I've watched several pharmaceutical companies embrace stem cell partners only to fall short in clinical advancements. Their strategic thinking was correct, they simply chose the wrong stem cell technology. We sincerely believe Stemedica's ischemic tolerant cells manufactured at their government licensed, cGMP facility can create statistical points of difference clinically. In working with Stemedica, we seek to validate the important role stem cells can play in treating COVID-19 and other lung-related conditions which will require global solutions in the not-too-distant future," said Snider.

Pulthera anticipates advancing a multi-center trial in the treatment of those already afflicted with COVID-19, better known as "Long Haulers Syndrome," beginning late in 2021. These efforts will be coordinated in collaboration with the current FDA authorized Phase Ila clinical trial Stemedica has already begun for COVID-19 patients hospitalized with Acute Respiratory Distress Syndrome.

Stemedica's Licensing Agreement with Pulthera is for the diagnosis, prevention and/or treatment of COVID-19 and complications thereof and for lung, pulmonary and respiratory conditions including, but not limited to, ARDS, Asthma, Bronchitis, COPD, Cystic Fibrosis, Emphysema, Pleural Effusion, Pneumonia, Pulmonary Fibrosis, and Reactive Airway Disease on a worldwide basis minus select markets where Stemedica already has contractual relationships in place.

About Stemedica Cell Technologies, Inc. is a global biopharmaceutical company that manufactures allogeneic adult stem cells and stem cell factors. The company is a government licensed manufacturer of cGMP, clinical-grade stem cells used in US-based clinical trials for ischemic stroke, COVID-19 and Alzheimer's disease. Stemedica's products are also used on a worldwide basis by research institutions and hospitals for pre-clinical and clinical (human) trials. Stemedica is currently developing additional clinical trials for other medical indications using adult, allogeneic stem cell under the auspices of the FDA and other international regulatory institutions. The company is headquartered in San Diego, California. http://www.stemedica.com

About Pulthera, LLC is a biopharmaceutical company focusing on the commercialization of "off the shelf" stem cell therapeutics designed to more effectively treat life-threatening inflammatory conditions in the lungs and COVID-19 related conditions. The Company has licensed the exclusive right to use, sell and distribute proprietary adult mesenchymal stem cells for all respiratory indications worldwide (some exclusions apply). Pulthera will participate in on-going clinical trials that are being led by its partners and will look to start its own clinical trials with the highest moral, ethical and safety standards. Visit http://www.pulthera.com for more information about the Company.

Contact: Dave McGuigandmcguigan@stemedica.com

View original content:http://www.prnewswire.com/news-releases/stemedica-signs-license-agreement-with-pulthera-llc-for-all-respiratory-indications-including-those-related-to-covid-19-301297498.html

SOURCE Stemedica Cell Technologies, Inc.

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Stemedica Signs License Agreement with Pulthera, LLC for all Respiratory Indications including those related to COVID-19 - BioSpace