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Category Archives: Stem Cell Therapy

Cell-Easy Leads the Way Towards Tomorrow’s Healthcare With Accessible Stem Cell Therapy – Business Wire

TOULOUSE, France--(BUSINESS WIRE)--Cell-Easy secures 1M capital investment and appoints Pierre Monsan as CEO. Thanks to its ground-breaking mesenchymal stem-cell large scale manufacturing process, Cell-Easy is set to democratise regenerative therapy, making treatments more affordable. The opening of its pharmaceutical plant is planned for the beginning of 2020 and the production of the first clinical batch later in the year.

Affordable treatments thanks to large scale manufacturingBased on the principles of cell therapy, regenerative medicine is shaking traditional medicine, offering treatments for previously incurable diseases. Taking by storm this fast growing market, the start-up Cell-Easy has raised 1M investment from private investors and experts and secured the appointment of Pierre Monsan as CEO and CSO (Chief Scientific Officer).

Pierre Monsan is Professor Emeritus at the INSA, Toulouse and Founder of Toulouse White Biotechnology (TWB) and of the French Federation of Biotechnology. He is confident in the future of this new entrepreneurial venture. He explains : Regenerative therapy is an international fast growing market. However it remains immature due to the limitations of stem cells manufacturing capabilities and the cost of treatments that still remains very high. Our ambition is to industrialise the manufacturing process to accelerate the use of stem cells in regenerative medicine and to become the market leader.

Despite the huge clinical potential of regenerative therapy, access to treatments and the cost remain major obstacles to its development. Today only the very rich can access cell therapy. Treatments can cost up to 350K per patient ! By streamlining the manufacturing process of stem cells, the major opportunity were offering is to industrialise the process associated with a very competitive cost price. Large scale stem cell manufacturing can cut costs by 10, maybe 100. Pierre Monsan adds.

A unique stem cell factory in EuropeTo be able to manufacture stem cell batches on a large scale, Cell-Easy has the latest research equipment and labs, built in accordance to the GMP (Good Manufacturing Practices) standards. They will open in the first quarter of 2020. By the end of 2020 the production capacity will reach 10 000 doses /year compared to its competitors producing a few hundred doses /year. Cell-Easy is planning to secure further capital investment to scale-up stem cell manufacturing and its international commercialisation.

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Global Stem Cell Therapy Contract Manufacturing Market Research 2019-2030: Source of Stem Cells, Types of Stem Cells, Size of Contract Service…

DUBLIN, Dec. 3, 2019 /PRNewswire/ -- The "Stem Cell Therapy Contract Manufacturing Market, 2019-2030" report has been added to ResearchAndMarkets.com's offering.

The Stem Cell Therapies Contract Manufacturing Market, 2019 - 2030 report features an extensive study on contract service providers engaged in the development and manufacturing of stem cell therapies. The study features in-depth analyses, highlighting the capabilities of various stem cell therapy CMOs.

Advances in the fields of cell biology and regenerative medicine have led to the development of a variety of stem cell-based therapies for many cardiovascular, oncological, metabolic and musculoskeletal disorders. Driven by the revenues generated from stem cell therapies, the regenerative medicine market is anticipated to generate revenues worth USD 100 billion by 2030. With a promising pipeline of over 200 stem cell therapy candidates, it has become essential for developers to scale up the production of such therapeutic interventions. Given that stem cell therapy manufacturing requires highly regulated, state-of-the-art technologies, it is difficult for stakeholders to establish in-house expertise for large-scale manufacturing of stem cell therapies.

As a result, stem cell therapy developers have begun outsourcing their manufacturing operations to contract manufacturing organizations (CMOs). Specifically, small and mid-sized players in this sector tend to outsource a substantial proportion of clinical and commercial-scale manufacturing processes to contract service providers. In addition, even big pharma players, with established in-house capabilities, are gradually entering into long-term business relationships with CMOs in order to optimize resource utilization and manage costs.

According to a recent Nice Insight CDMO survey, about 55% of 700 respondents claimed to have collaborated with a contract service provider for clinical and commercial-scale product development requirements. Considering the prevalent trends, we believe that the stem cell therapy manufacturing market is poised to grow at a steady pace, driven by a robust pipeline of therapy candidates and technological advances aimed at mitigating challenges posed by conventional methods of production. Amidst tough competition, the availability of cutting-edge tools and technologies has emerged as a differentiating factor and is likely to grant a competitive advantage to certain CMOs over other players in the industry.

One of the key objectives of the report was to estimate the future size of the market. Based on parameters, such as increase in number of clinical studies, target patient population, anticipated adoption of stem cell therapies and expected variation in manufacturing costs, we have provided an informed estimate of the likely evolution of the market in the mid to long term, for the period 2019-2030.

Amongst other elements, the report includes:

In order to provide a detailed future outlook, our projections have been segmented on the basis of:

Key Topics Covered:

1. Preface

2. Executive Summary

3. Introduction

4. Market Overview

5. Regulatory Landscape

6. Stem Cell Therapy Contract Manufacturers In North America

7. Stem Cell Therapy Contract Manufacturers In Europe And Asia-Pacific

8. Partnerships And Collaboration

9. Contract Manufacturing Opportunity Assessment

10. Capacity Analysis

11. Demand Analysis

12. Market Forecast

13. Key Performance Indicators

14. Concluding Remark

15. Executive Insights

16. Appendix 1: Tabulated Data

17. Appendix 2: List Of Companies And Organizations

For more information about this report visit https://www.researchandmarkets.com/r/jwfp7v

Research and Markets also offers Custom Research services providing focused, comprehensive and tailored research.

Media Contact:

Research and Markets Laura Wood, Senior Manager press@researchandmarkets.com

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Stem cell therapy shows promise for the first time in spinal cord injury – News-Medical.net

Researchers have published the results of their work where stem cell therapy has shown promise in a case of spinal cord injury. The results of their case study were published in the latest issue of the journal Mayo Clinic Proceedings last week. The study was titled, Celltop Clinical Trial: First Report From a Phase I Trial of Autologous Adipose-Derived Mesenchymal Stem Cells in the Treatment of Paralysis Due to Traumatic Spinal Cord Injury.

Early research published in Mayo Clinic Proceedings examines the first case at Mayo Clinic of stem cell therapy tested in humans for spinal cord injury. Image Credit: Mayo Clinic

This was essentially the first case and a Phase I clinical trial to see the safety of the procedure said Mohamad Bydon, a Mayo Clinic neurologic surgeon and the lead author of the study. The team used mesenchymal stem cell treatment for the patient and they added a warning that not all patients may show the same levels of success as this case. Dr. Bydon explained, While in this case, the first subject was a super-responder, others may not respond in the same manner. We do not yet understand all of the necessary biology needed to achieve neurological recovery in paralyzed individuals. One of our objectives in this study and future studies is to better delineate who will be a responder and why patients respond differently.

The team wrote that over 17000 persons in the United States suffer from traumatic spinal cord injury annually and the burden of the injuries affect 291,000 or more annually. These injuries thus form a major socioeconomic burden and cost the health care system over $40 billion including the loss as work force. Regenerative medicine using stem cells have been one avenue that has been explored in the recent years to seek for answers to paralysis caused due to spinal cord injuries. The team wrote that the, adipose tissue represents a readily accessible and viable source of MSCs. Available evidence has shown that adipose tissue derived (AD) MSCs can regulate inflammatory responses and provide a regeneration-permissive environment in animal models of SCI.

This trial, the team wrote, was planned with 10 patients who were paralyzed as a result of traumatic spinal cord injury (SCI). Mesenchymal stem cell therapy was tried on the patients and one of them showed motor as well as sensory benefits from the therapy and did not show any side effects of adverse reactions. They wrote, The CELLTOP study, an ongoing multidisciplinary phase 1 clinical trial conducted at Mayo Clinic (ClinicalTrials.gov Identifier: NCT03308565), is investigating the safety and efficacy of intrathecal autologous AD-MSCs in patients with blunt, traumatic SCI. (AD MSCs - Adipose tissue derived mesenchymal stem cells).

The patient, 53 year old man, Chris Barr, said that he had never hoped to regain motor or sensory functions after his surfing accident. In his recent interview to the media he has said, The prognosis was was bad... And bad meaning, you know, probably a 95 to 97 percent chance that Ill have nothing below my neck. His injury was labelled as American Spinal Injury Association Impairment Scale grade A.

For this procedure where he was the first to sign up, he underwent stem cell therapy which had never been tried before. Stem cells were taken from his own body and in the lab they were coaxed into turning into becoming spine cells. These stem cells were derived from the adipose tissues or fat cells. Authors wrote that 100 million autologous AD-MSCs were then injected back into his spinal cord at the level of the lumbar spine. This was done 11 months after the spinal injury Barr suffered. With regular physiotherapy after the treatment, Barr has regained his senses in the lower limbs and can walk on his own feet, explain the researchers. The patients was tested for any side effects at 3, 6, 12 and 18 months after the injection of the stem cells to his spine.

Authors wrote in conclusion, Thus, in this treated individual with SCI, intrathecal administration of AD-MSCs was feasible and safe and suggested meaningful signs of improved, rather than stabilized, neurologic status warranting further clinical evaluation.

According to Dr. Bydon, despite the fact that not all may respond similarly, this study spkrks hope among hundreds of thousands of individuals who suffer from traumatic spinal cord injuries each year and remain paralyzed for life. Bydon said, The hope is that we will have novel treatments for spinal cord injuries in the coming years that will be different from what we have today. These will be therapies that do not rely upon supportive care, but therapies that rely on science to create a regenerative process for the spinal cord.

Journal reference:

CELLTOP Clinical Trial: First Report From a Phase 1 Trial of Autologous Adipose TissueDerived Mesenchymal Stem Cells in the Treatment of Paralysis Due to Traumatic Spinal Cord Injury Bydon, Mohamad et al. Mayo Clinic Proceedings, https://www.mayoclinicproceedings.org/article/S0025-6196(19)30871-7/fulltext

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New Stem Cell Research Could Make Cancer Treatments affordable and Effective for Hospitals and Patients – PRNewswire

SAN FRANCISCO, Dec. 2, 2019 /PRNewswire/ -INTELLiSTEM Technologies, a pioneering research company revolutionizing stem cell medicine, is helping to create an affordable future for cancer therapies. Currentcancer cell therapies likeCAR T Cells cost between$350k (USD) and $500k (USD.)INTELLiSTEM expects its Super SentinelCells(SSCs) treatment to be priced between$30-$50k USD. This represents a massive difference in price for hospitals and patients paying or co-paying for their own treatments.

"Older generations of cell therapies require harvesting the cells from the patients, processing them, manufacturing them and then injecting them back into the patient," said Dr. Riam Shammaa, MD Founder and CEO of INTELLiSTEM."Most of those cells can't be grown in large quantities and are very difficult to manufacture, driving the cost way up. Our solution is based on genetically engineering 'off-the-shelf cells 'ready to inject directly into patients. Our cells are easy to grow into billions of cells to treat multiple patients and this drops the cost substantially."

According to Shammaa, the highcurrent cost of cell therapies likeCAR T Cells and dendriticcellsis not only unsustainable(causinga heavy financialburdenfor hospitals acrossNorth America) but is also making life-saving cancer therapies financially inaccessible to millions of patients.

INTELLiSTEM Researchers have created genetically engineered Super Sentinel Cells(SSC's) to effectively target Cancer cells.The SSC's are showing an unprecedented 80% success rate in animal models.The current success rate for existing Cancer cell therapy treatments is 20-40%.

INTELLiSTEM is currently moving into phase one of human trials with the SSC's within the next 12 months.

"We could see practical cures for specific Cancers in as little as 5-7 years," added Shammaa.

See animated video of SSC'shere high-resolution Images also available.

How does the treatment work?

Cancer cells are very good at hiding from the immune system. Essentially, the Super Sentinel Cells are the next generation of antigen-presentingcells, theyshow the immune system where the Cancer cells are hiding in a host and allow the immune system to kick in and attack/kill them.

What Cancers could this effectively treat?

Super Sentinel Cells have the capacity to targethematological and solid cancersdue to their ability to learn the signals and antigens of each cancer. Due to the massive task at hand and to accelerate the progression of multiple Cancer cures, INTELLiSTEM started collaborating with cancer centers across the United States and is also looking to collaborate with research institutions around the world to accelerate the accessibility of the therapy to patients. The SSC's are expected to be effective on solid tumors such as Breast Cancer,Lung Cancer, Melanoma, Prostate Cancer and Lymphomas.

How many treatments are required?

Animal models are showing that 80% of the tested animals survive after one treatment compared to 20% using availablecell therapiesand 0% without treatment, but Shammaa believes that 100% can be achieved with a second injection/treatment of Super Sentinel Cells.

SOURCE INTELLiSTEM Technologies

https://www.intellistemtech.com/

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Stem of the problem | Columns | Journal Gazette – Fort Wayne Journal Gazette

I have been reading a book, The Man Who Wouldn't Die, that satirizes Silicon Valley and the venture-capital start-up culture. It's reasonably funny. I was reminded, however, that sometimes culture is crazy.

At one point a character casually describes how stem-cell therapy is obviously going to make 50-year-olds feel like 20-year-olds. Grow a new liver and you're good to go, so to speak! The author clearly meant the idea as a joke. However, that idea is out there and taken seriously. Stem cells made national headlines in the late '90s and early 2000s because of some scientific breakthroughs and their promise for future medical treatments.

Just about all of our body is made up of specialized cells. These are cells that have grown to perform some specific function. Some examples are heart muscle cells, say, or red blood cells.

Stem cells are different; they have not yet specialized. That is, they have not developed many of the specific properties that are unique to the different parts of our bodies.

Given the right environment the right chemicals, for examplethey can grow into specialized cells.

There are, of course, all sorts of important details for how stem cells grow, when they specialize and how much flexibility they have in specializing. Somehow, however, there is now an industry that has skipped all that work and is marketing stem cells as a general cure. Alzheimer's disease and joint pain are frequently mentioned. If that makes you suspicious that these clinics are targeting the elderly, you would be right.

A typical treatment involves taking stem cells from a patient's bone marrow or fat and injecting it back into a sore knee or hip or whatever needs fixing. The idea, somewhat vaguely, is that the stem cells will grow to replace whatever is worn down by age.

As is true of all good scams, this one has a good story, one that can pass as proven medicine for many patients. The treatment also benefits by treating a problem with symptoms that can come and go irregularly, so a patient can honestly claim that they recovered in, say,six months.

The body is a complicated machine. It is hard to predict what will cure or not cure any specific problem. Just because a story involving stem cells sounds reasonable is not a sufficient reason to try something.

For a typical patient, we should have good, strong, positive evidence that a treatment will help. A good story is not strong, positive evidence. In the language of science, it is a hypothesis. Potentially true.

It is worth remembering that many, many things are potentially true. We don't try them all out on ourselves when we are sick.

Many of these ideas have in fact been tested in rigorous, peer-reviewed studies. So far, the evidence for positive effects is weak.

One reason these clinics have managed to skirt the rules is that extracting material from a patient then reinjecting requires less oversight for safety. Depending on the details, this treatment is considered, for Food and Drug Administration regulations, something like plasma donation (where blood is extracted, platelets removed, then reinjected into the body).

Just because a process may be safe does not make it good medicine. Medicine is not and should not be a free market. Patients will almost never have enough knowledge to reasonably choose between treatment options.

The FDA is the federal agency in charge of ensuring companies do not offer useless or harmful procedures. Unfortunately, in 2017 the FDA decided to allow stem cell clinics a three-year grace period to describe their procedures for the FDA's evaluation. As a result of that open window, hundreds of clinics have opened nationwide, offering services for which there is no strong evidence.

In the past year the FDA has realized where the industry has gone with this treatment and begun trying to crack down. Some clinics have unsafe procedures; others are misleading patients about treatments. Many clinics are still operating, unfortunately, and it can be difficult for typical patients to recognize the difference between these treatments and proven remedies. Furthermore, these bad actors could potentially make people skeptical of stem cell-based technology entirely.

That would be a shame because there is still great promise for stem cells. That may be cold comfort for those who want a treatment immediately, but that desire is the exact motivation that has led to terrible medicine for centuries.

Christer Watson, of Fort Wayne, is a professor of physics at Manchester University. Opinions expressed are his own. He wrote this column for The Journal Gazette, where his columns normally appear the first and third Tuesday of each month.

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Stem cells may trigger immune repair to mend hearts – BioNews

2 December 2019

Stem cell therapies may become redundant in repairing cardiac function after a heart attack, suggests a new study in mice.

It showed how stem cell treatments can heal hearts by triggering an immune response which can be achieved by using a chemical instead.

'This work is paradigm-shifting because it demonstrates a mechanism to explain a perplexing phenomenon that has intrigued cardiologists as a result of decades of cardiac stem cell trials,' Dr Jonathan Epstein at the University of Pennsylvania's Perelman School of Medicine in Philadelphia told The Scientist.

Stem cell therapies to repair damaged heart tissue are currently being tested in human clinical trials. In these treatments, human stem cells are injected into the heart and this leads to an improvement in heart function. However, how this works is not fully understood.

One possibility is that the injected stem cells are incorporated into the heart tissue and repair the damage. However, the latest study, published in the journal Nature, suggests that this may not be the case. Instead, the study indicated that the repair is actually a result of triggering the innate immune response.

Researchers injected different types of stem cell or a chemical inducer (zymosan) of the innate immune response into an experimental mouse model of heart disease. They saw improvement in heart function that was similar in all cases, and showed that this repair occurs via activation of macrophage cells of the innate immune system.

'The innate immune response acutely altered cellular activity around the injured area of the heart so that it healed with a more optimised scar and improved contractile properties,' said Dr Jeffery Molkentin at the University of Cincinnati and Cincinnati Children's Hospital Medical Centre, Ohio, who led the study. 'The implications of our study are very straightforward and present important new evidence about an unsettled debate in the field of cardiovascular medicine.'

The work could open up new possibilities for optimising the treatments currently in development, as well as alternative new therapies.

'If there is a chemical off-the-shelf, it would be a much more feasible therapy [than stem cell transplants],'Dr Kory Lavine at Washington University in St Louis, Missouri, told Nature News.

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