Category Archives: Stem Cell Therapy

Testing a new therapeutic in human subjects for the first time is a major step in the translation of any novel treatment from the laboratory bench to clinical use.

When the therapeutic represents a paradigm shift, reaching this milestone is even more significant.

After years of planning, preparation and hard work to establish a base camp, starting human clinical trials is the first step towards the summit itself: gaining regulatory approval for product sales.

Exosomes tiny packets of proteins and nucleic acids (e.g. mRNA and miRNA) released by cells, that have powerful regenerative properties ranging from promoting wound healing to stimulating brain injury recovery following stroke represent just such a paradigm-shifting potential advance in human medicine.

The first commercial exosome therapeutics conference was held in Boston in September 2019 and over 15 companies participated.

This conference signals the emergence of exosomes as a new class of regenerative medicine products.

So far, just one or two of the companies working in the novel field of exosome-based therapies have reached the pivotal point and transitioned into human clinical trials. In this article we survey the field, starting with the pace-setters.

During the past few years, a handful of universities and research hospitals have carried out small scale, first-in-human Phase I clinical trials using exosomes. In each case where the study results are available, the exosome treatment was found to be safe and well-tolerated.

But the field has hotted up in the past few months, with the first companies reaching the pivotal point of testing exosome-based products in people.

On 28th January 2020, Melbourne-based Exopharm announced the first dosing under its first human clinical trial, becoming the first company to test exosomes potential for healing wounds in people.

The PLEXOVAL Phase I study will test Exopharms Plexaris product, a cell-free formulation of exosomes from platelets, which in preclinical animal studies have shown a regenerative effect, improving wound closure and reducing scarring.

The main readouts of the PLEXOVAL study the results of which are expected to be available sometime after mid-2020 will be safety, wound closure and scarring.

Joining Exopharm at the front of the pack is Maryland-based United Therapeutics.

Founded in 1996, United Therapeutics specialises in lung diseases and has a portfolio of FDA-approved conventional small molecule and biologic drugs on the market for a range of lung conditions.

On 26th June 2019, United Therapeutics announced approval for a Phase I trial (NCT03857841) of an exosome-based therapy against bronchopulmonary dysplasia (BDP), a condition common in preterm infants that receive assisted ventilation and supplemental oxygen.

Recruitment has commenced but dosing has not been announced. The study is due to conclude by December 2021. BDP is characterised by arrested lung growth and development, with health implications that can persist into adulthood.

Human clinical trials of a stem cell therapy for BDP, by Korean stem cell company Medipost, are already underway. However as with many stem cell therapies recent animal studies have shown that is the exosomes released by stem cells that are responsible for the therapeutic effect.

United Therapeutics therapy, UNEX-42, is a preparation of extracellular vesicles that are secreted from human bone marrow-derived mesenchymal stem cells. The company has not released any information about how its exosomes are produced or isolated.

A little behind the two leaders, three other companies have announced their aim to initiate their first clinical trials of exosome therapeutics within the next 12 months.

Launched in 2015, Cambridge, Massachusetts-based Codiak has long been considered among the leaders in developing exosome-based therapies.

Rather than exploiting the innate regenerative potential of select exosome populations, Codiak is developing engineered exosomes that feature a defined therapeutic payload. The companys initial focus has been to target immune cells, leveraging the immune system to combat cancer.

The company plans to initiate clinical trials of its lead candidate, exoSTING, in the first half of 2020. The therapeutic is designed to trigger a potent antitumor response from the patients own immune system, mediated by T cells. A second immuno-oncology candidate, exoIL-12, is due to enter clinical trials in the second half of 2020, the company says.

In nearby New Jersey, Avalon Globocare is also developing engineered exosomes. Its lead product, AVA-201, consists of exosomes enriched in the RNA miR-185, which are produced using engineered mesenchymal stem cells.

In animal tests, miR-185 suppressed cancer cell proliferation, invasion and migration in oral cancer. In July 2019, the company announced plans to start its first exosome clinical trial before the close of 2019. As of February 2020, however, no further announcement regarding this clinical trial has been made.

Avalon has also made no further announcement on a second planned clinical trial, also intended to start during the fourth quarter of 2019, of a second exosome candidate, AVA-202.

These angiogenic regenerative exosomes, derived from endothelial cells, can promote wound healing and blood vessel formation, the company says. The planned Phase I trial was to test AVA-202 for vascular diseases and wound healing.

Meanwhile, Miami-based Aegle Therapeutics plans to begin a Phase I/IIa clinical trial of its exosome therapy, AGLE-102, during 2020. AGLE-102 is based on native regenerative exosomes isolated from bone marrow mesenchymal stem cells.

After initially focussing on burns patients, in January 2020 to company announced had raised the funds to commence an FDA-cleared clinical trial of AGLE-102 to treat dystrophic epidermolysis bullosa, a rare paediatric skin blistering disorder. The company says it plans to commence this clinical trial in the first half of 2020.

A number of companies are in the preclinical phase of exosome therapy research.

Some of these companies have been set up specifically to develop exosome-based products. In the UK, Evox co-founded by University of Oxford researcher Matthew Wood in 2016 is developing engineered exosomes to treat rare diseases.

The company has developed or sourced technology that allows it to attach proteins to exosomes surface, or to load proteins or nucleic acids inside the exosome, to deliver a therapeutic cargo to a target organ.

Its lead candidate targets a lysosomal storage disorder called Niemann-Pick Disease type C, using exosomes that carry a protein therapeutic cargo. Evox says it plans to submit the Investigational New Drug (IND) application to the FDA during 2020, paving the way for the first clinical trial. It currently has five other candidates, for various indications, at the preclinical stage of development.

In Korea, Ilias and ExoCoBio are developing exosome therapeutics. Ilias founded by faculty from the Korean Advance Institute of Science and Technology specialises in loading large protein therapeutics into exosomes.

It is currently carrying out preclinical research toward treating sepsis, preterm labour and Gauchers disease. ExoCoBio is focusing on the native regenerative capacity of exosomes derived from mesenchymal stem cells, including to treat atopic dermatitis.

New companies continue to enter the exosome space. In August 2019, Carmine Therapeutics was launched, with the aim to develop gene therapies that utilize exosomes from red blood cells to deliver large nucleic acid cargoes. The company is targeting the areas of haematology, oncology and immunology.

Meanwhile, a wave of companies originally set up to develop live stem cell therapies are diversifying into stem cell derived exosome production and research.

It is now generally acknowledged that stem cell exosomes are the main therapeutically active component of stem cells, and that medical products based on exosomes will be safer to apply, and easier and cheaper to make and transport, than live cell therapies.

Originally established to produce neural stem cells for other research organisations, Aruna Bio has developed proprietary neural exosomes that can cross the blood brain barrier.

The company is now developing an exosome therapy for stroke. In October 2019, the Athens, Georgia-based company said had raised funding to support the research and development to enable its first IND application to the FDA in 2021.

In the UK, ReNeuron has also focussed on stroke, and has several clinical trials underway assessing its CTX stem cells to promote post stroke rehabilitation. The company is also working with third parties to investigate the drug- and gene therapy delivery potential of exosomes derived from CTX stem cells.

Switzerland-based Anjarium is also developing an exosome platform to selectively deliver therapeutics.20 The company is focussing on engineering exosomes loaded with therapeutic RNA cargo and displaying targeting moieties on its surface.

California-based Capricor has commenced clinical trials of a cardiosphere-derived stem cell therapy for the treatment of Duchenne muscular dystrophy (DMD).

At an earlier phase, its regenerative exosome therapy CAP-2003 is in pre-clinical development for a variety of inflammatory disorders including DMD.

A number of other stem cell companies, including TriArm, Creative Medical, AgeX Therapeutics and BrainStorm Cell Therapeutics, are reported to be investigating exosome-based therapies derived from their stem cell lines.

Exopharms position as a frontrunner in bringing exosomes into humans is no lucky accident. The companys operations are based around its unique, proprietary method for manufacturing and isolating exosomes, known as LEAP technology.

As academics and observers of the exosome field have pointed out, reliable and scalable exosome manufacture has threatened to be a major bottleneck that limits the translation of exosome therapeutics into clinical use. The standard laboratory-scale method for collecting the exosomes produced by cultured cells has been to spin the liquid cell culture medium in an ultracentrifuge, or pass it through a fine filter.

The most common technique used so far, the ultracentrifuge, has major scalability limitations. Issues include the high level of skill and manual labour required, the time-intensive nature of the process, and the associated costs of reagents and equipment. It is impossible to imagine collecting enough exosomes for a late stage clinical trial this way.

Another issue is the low purity of the exosomes collected. These techniques sort the contents of cell culture medium by their mass and/or size. Although the exosomes are concentrated, they could be accompanied by other biological components present in the cell culture medium that happen to be a similar size or mass to the exosome.

Importantly, a biotechnology company needs a proprietary step in the process to make a proprietary product over which it has exclusivity. Exopharms LEAP technology is a good example of a proprietary manufacturing step. Ultracentrifuge is not a proprietary process.

So the big players in the emerging exosome field have generally placed a strong emphasis on developing their manufacturing and purification capability.

Exopharm developed a chromatography-based purification method, in which a patent-applied-for inexpensive functionalised polymer a LEAP Ligand is loaded into a chromatography column. The LEAP Ligand sticks to the membrane surface of exosomes passed through the column. Everything else in the cell culture medium mixture is simply washed away. The pure exosome product is then eluted from the column and collected for use. As well as being very scalable, the technique is versatile. LEAP can be used to produce a range of exosome products, by isolating exosomes from different cell sources.

Codiak, similarly, says it has developed scalable, proprietary chromatography-based methods to produced exosomes with comparable identity, purity, and functional properties as exosomes purified using methods such as ultracentrifugation. Chromatography is a flow-based technique for separating mixtures. In an April 2019 SEC filing, the company said it is establishing its own Phase 1/2 clinical manufacturing facility, which it is aiming to have fully-operational by first half 2020.

Avalon GloboCare teamed up with Weill Cornell Medicine to develop a standardised production method for isolating clinical-grade exosomes. Aegle also says it has a proprietary isolation process for producing therapeutic-grade exosomes. And Evox emphasises the GMP compliant, scalable, commercially viable manufacturing platform it has developed.

At Exopharm, the manufacturing technique that has allowed the company to leap ahead of the pack and into human clinical trials is its proprietary LEAP platform. Overcoming the exosome production and isolation bottleneck was exactly the problem the companys scientists set out to solve when Exopharm formed in 2013.

In addition to the Plexaris exosomes, isolated from platelets, currently being tested in human clinical trials, Exopharm is progressing toward human clinical trials of its second product, Cevaris, which are exosomes isolated from stem cells.

Exosomes are now under development by around 20 companies across the world. The leaders in the field are now entering clinical trials with both nave exosome products and engineered exosome products. A number of cell therapy companies are also moving across into the promising exosome product space.

The coming years promise dynamic changes, with partnerships and eventually product commercialization. Exopharm is a clear leader in this emerging field.

(Featured image by Darko Stojanovic from Pixabay)

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Stem Cell Therapy Market: Snapshot

Of late, there has been an increasing awareness regarding the therapeutic potential of stem cells for management of diseases which is boosting the growth of the stem cell therapy market. The development of advanced genome based cell analysis techniques, identification of new stem cell lines, increasing investments in research and development as well as infrastructure development for the processing and banking of stem cell are encouraging the growth of the global stem cell therapy market.

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One of the key factors boosting the growth of this market is the limitations of traditional organ transplantation such as the risk of infection, rejection, and immunosuppression risk. Another drawback of conventional organ transplantation is that doctors have to depend on organ donors completely. All these issues can be eliminated, by the application of stem cell therapy. Another factor which is helping the growth in this market is the growing pipeline and development of drugs for emerging applications. Increased research studies aiming to widen the scope of stem cell will also fuel the growth of the market. Scientists are constantly engaged in trying to find out novel methods for creating human stem cells in response to the growing demand for stem cell production to be used for disease management.

It is estimated that the dermatology application will contribute significantly the growth of the global stem cell therapy market. This is because stem cell therapy can help decrease the after effects of general treatments for burns such as infections, scars, and adhesion. The increasing number of patients suffering from diabetes and growing cases of trauma surgery will fuel the adoption of stem cell therapy in the dermatology segment.

Global Stem Cell Therapy Market: Overview

Also called regenerative medicine, stem cell therapy encourages the reparative response of damaged, diseased, or dysfunctional tissue via the use of stem cells and their derivatives. Replacing the practice of organ transplantations, stem cell therapies have eliminated the dependence on availability of donors. Bone marrow transplant is perhaps the most commonly employed stem cell therapy.

Osteoarthritis, cerebral palsy, heart failure, multiple sclerosis and even hearing loss could be treated using stem cell therapies. Doctors have successfully performed stem cell transplants that significantly aid patients fight cancers such as leukemia and other blood-related diseases.

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Global Stem Cell Therapy Market: Key Trends

The key factors influencing the growth of the global stem cell therapy market are increasing funds in the development of new stem lines, the advent of advanced genomic procedures used in stem cell analysis, and greater emphasis on human embryonic stem cells. As the traditional organ transplantations are associated with limitations such as infection, rejection, and immunosuppression along with high reliance on organ donors, the demand for stem cell therapy is likely to soar. The growing deployment of stem cells in the treatment of wounds and damaged skin, scarring, and grafts is another prominent catalyst of the market.

On the contrary, inadequate infrastructural facilities coupled with ethical issues related to embryonic stem cells might impede the growth of the market. However, the ongoing research for the manipulation of stem cells from cord blood cells, bone marrow, and skin for the treatment of ailments including cardiovascular and diabetes will open up new doors for the advancement of the market.

Global Stem Cell Therapy Market: Market Potential

A number of new studies, research projects, and development of novel therapies have come forth in the global market for stem cell therapy. Several of these treatments are in the pipeline, while many others have received approvals by regulatory bodies.

In March 2017, Belgian biotech company TiGenix announced that its cardiac stem cell therapy, AlloCSC-01 has successfully reached its phase I/II with positive results. Subsequently, it has been approved by the U.S. FDA. If this therapy is well- received by the market, nearly 1.9 million AMI patients could be treated through this stem cell therapy.

Another significant development is the granting of a patent to Israel-based Kadimastem Ltd. for its novel stem-cell based technology to be used in the treatment of multiple sclerosis (MS) and other similar conditions of the nervous system. The companys technology used for producing supporting cells in the central nervous system, taken from human stem cells such as myelin-producing cells is also covered in the patent.

Global Stem Cell Therapy Market: Regional Outlook

The global market for stem cell therapy can be segmented into Asia Pacific, North America, Latin America, Europe, and the Middle East and Africa. North America emerged as the leading regional market, triggered by the rising incidence of chronic health conditions and government support. Europe also displays significant growth potential, as the benefits of this therapy are increasingly acknowledged.

Asia Pacific is slated for maximum growth, thanks to the massive patient pool, bulk of investments in stem cell therapy projects, and the increasing recognition of growth opportunities in countries such as China, Japan, and India by the leading market players.

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Global Stem Cell Therapy Market: Competitive Analysis

Several firms are adopting strategies such as mergers and acquisitions, collaborations, and partnerships, apart from product development with a view to attain a strong foothold in the global market for stem cell therapy.

Some of the major companies operating in the global market for stem cell therapy are RTI Surgical, Inc., MEDIPOST Co., Ltd., Osiris Therapeutics, Inc., NuVasive, Inc., Pharmicell Co., Ltd., Anterogen Co., Ltd., JCR Pharmaceuticals Co., Ltd., and Holostem Terapie Avanzate S.r.l.

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Stem Cell Therapy Market Trends and Growth, Outlook, Research, Trends and Forecast to 2025 - Instant Tech News

ALBANY, New York, Feb. 4, 2020 /PRNewswire/ -- Amid technological advancement, and notable research and development activities, the global radiation therapy marketis set to chart a sturdy growth curve, owing to a steady growth rate of 5.2% from 2018 to 2026. As per Transparency Market Research (TMR), the growth is attributable to surge in product approvals, increase in expenditure on healthcare, high incidence of cancer, and a growing preference for non-invasive treatment procedures.

TMR states that, "From bench to clinic, there is a wave of therapeutic and diagnostic technologies, paving way for higher growth in oncology. And, this will aid radiation therapy witness better times to come. Over the forecast period external beam radiation therapy will dominate the market landscape."

Key Findings of the Radiation Therapy Market Study

Explore 183 pages of top-notch research, incisive insights, and detailed country-level projections. Gain business intelligence on radiation therapy market by Type - External Beam Radiation Therapy (Conformal Radiation Therapy, Proton Beam Therapy, Image Guided Radiation Therapy, Stereotactic Radiation Therapy), Internal Radiation Therapy (Brachytherapy, Systemic Radiation Therapy); End user - Hospitals, Specialty Clinics. https://www.transparencymarketresearch.com/sample/sample.php?flag=S&rep_id=36080

Radiation Therapy Market: Key Driving Factors

The market report, based on extensive research, by Transparency Market Research, is leading to growth in the landscape. And, a wave of innovation is keeping the statistics buoyant over the period. Some of the factors that will sustain growth over the forecast period in the global radiation therapy market include the following:

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Key Impediments for Radiation Therapy Market Players

While the overall outlook of the global radiation therapy market is positive, TMR speaks of certain restraints that will hamper growth to some extent. According to the study, the key restraints impeding market growth include,

Radiation Therapy Market: Region-wise Analysis

Analyze radiation therapy market growth in 30+ countries including US, Canada, Germany, United Kingdom, France, Italy, Russia, Poland, Benelux, Nordic, China, Japan, India, and South Korea. Request a sampleof the study,

Competition Landscape

Strategic alliances and a keen focus on technological advancement is the key to growth for players operating in the global radiation therapy market over the forecast period. One of the most notable agreement that took place in the recent past November 2018 is that between Chengdu Xingcheng and Mevion. The aim behind the move is to lead center for proton therapy in China's sub-provincial city Chengdu.

Besides, players are focused on product development and launch. For instance, in the year 2018, ProBeam 360 a system of single room proton therapy - was launched by Varian Medical Systems. In the same year Hitachi Ltd. received approval for commercialization of RGPT.

Key players include Varian Medical Systems, Inc. (US), Elekta (Sweden), Accuray Incorporated (US), Ion Beam Applications SA (Belgium), ViewRay, Inc. (US), IsoRay Medical, Inc. (US), Hitachi Ltd. (Japan), Panacea Medical Technologies Pvt. Ltd. (India), Provision Healthcare (US), and Mevion Medical Systems, Inc. (US)

Transparency Market Research has segmented the radiation therapy market report based on type, end-use and region.

By Type:

External beam Radiation Therapy

Internal Radiation Therapy

By End user:

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External Beam Radiation Therapy Market- External beam radiation therapy is the most common type of radiation therapy used in cancer treatments around the world. During the therapy, high-intensity radiation beams form a linear accelerator are focused on the tumor. Major drivers of the global external beam radiation therapy market are increase in patient population, new product approvals, technological advancements, favorable reimbursement policies, and rise in health care expenditure in developing economies such as India and others.

Proton Therapy Market- Rise in prevalence of cancer patients, growing awareness among people, improvement in insurance coverage for proton therapy, increase in consumption of tobacco, and surge in demand for proton therapy are factors driving the global proton therapy market. Tobacco use is associated with increased risk of several cancers including lung, oral cavity, pharynx, bladder, esophagus, kidney, liver, stomach, larynx, pancreas, bowel, cervix, leukemia, and ovarian.

Cancer Biomarkers Market- The global cancer biomarkers market is expected to exhibit a splendid CAGR of 11.8% during the forecast period from 2017 to 2025. In this timeframe, the market is anticipated to gain revenue worth US$27.63 bn by the end of 2025. Increasing incidences of various types of cancers all over the globe has caused a rise in the need for cancer biomarkers, thereby providing a healthy impetus to the associated market.

Cancer Cachexia Market- The cancer cachexia market stood at US$1.63 bn and is projected to garner a CAGR of 4.90% from 2017 to 2025. By the end of this assessment period, opportunities in the market will climb to US$2.51 bn. The growth of the global cancer cachexia market is fueled by vast research on using multiple agents for treating metabolic abnormalities in cachexia. Development of these multiple pharmacologic agents will further gather steam on the back of regulatory landscape.

Stem Cells Market- the global market for stem cells is projected to reach a value of US$270.5 bn by the end of 2025. The market is likely to exhibit a strong 13.80% CAGR between 2017 and 2025. The rapid development of the infrastructure that is required for the stem cell banking and processing, especially in developing economies is predicted to encourage the growth of the global stem cells market in the coming years.

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Global Radiation Therapy Market to Reach US$ 8.6 bn by 2026, Product Approvals to Drive Growth: Transparency Market Research - PRNewswire

Gilbert, Arizona based alternative medicine specialist Dr. Farid Rooh launched a new webinar on stem cell therapy, exosome injections, and other regenerative medicine therapies for chronic pain.

(Newswire.net -- February 3, 2020) -- Gilbert, AZ -- Gilbert, Arizona based alternative medicine specialist Dr. Farid Rooh launched a new webinar on stem cell therapy, exosome injections, and other regenerative medicine therapies for chronic pain.

Dr. Farid Rooh-Parvar DPSc, BCIM of Wellness 1st Integrative Medical Center in Gilbert, Arizona, announced a new webinar on the most effective regenerative medicine therapies for chronic and acute pain, arthritis, sciatica and other conditions.

More details can be found at http://bit.ly/2L8DNxY.

The newly released webinar aims to answer a series of important questions related to the most effective ways to address pain resulting form a variety of musculoskeletal conditions.

Dr. Rooh discusses the numerous applications of research-based regenerative medicine on countless patients who have seen important improvements in terms of pain relief, improved function and mobility.

The new webinar includes a detailed look at therapeutic approaches including stem cell therapy, exosome injections, amniotic tissue, adipose tissue and bone marrow therapies and more.

The focus is on helping viewers get a basic understanding on how the latest innovations in alternative, holistic and regenerative medicine can help patients suffering from a diverse range of health issues.

The webinar provides essential insights into the applications of regenerative medicine for the treatment and management of neck, back, shoulder and join pain, sciatica, arthritis, tennis elbow, loss of feeling in feet and other conditions.

All approaches are based on identifying and addressing the root cause of the patients health issues, rather than simply alleviating the symptoms.

With the latest announcement, Dr. Rooh continues to expand his range of high-quality alternative and regenerative medicine resources for patients in Arizona and beyond.

An experienced practitioner specializing in holistic and alternative medicine, Dr. Rooh offers personalized treatments for patients in Gilbert, Chandler and the surrounding areas of Arizona.

A satisfied patient said: As a new patient I was beyond impressed with this medical facility. During my consultation the kind and approachable Dr. Rooh met with me then his outstanding case manager Casi spent time with me exploring my options for a treatment plan that best suits my needs and situation. I can't express what a wonderful experience this was and I am so excited to be a new patient of theirs.

Interested parties can find more information by visiting the above-mentioned website.

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Stem Cell Pain Relief No Surgery Regenerative Therapy Webinar Released - Newswire

DetailsCategory: DNA RNA and CellsPublished on Tuesday, 04 February 2020 18:08Hits: 145

RESEARCH TRIANGLE PARK, NC, USA I February 04, 2020 IAsklepios BioPharmaceutical (AskBio), a clinical-stage adeno-associated virus (AAV) gene therapy company, and its NanoCor Therapeutics subsidiary today announced that the first patient has been dosed in a Phase 1 clinical trial of NAN-101. NAN-101 is a gene therapy that aims to activate protein phosphatase inhibitor 1 (I-1c) to inhibit the activity of protein phosphatase 1 (PP1), a substance that plays an important role in the development of heart failure.

Congestive heart failure (CHF) is a condition in which the heart is unable to supply sufficient blood and oxygen to the body and can result from conditions that weaken the heart muscle, cause stiffening of the heart muscles, or increase oxygen demand by the body tissues beyond the hearts capability.

"Dosing the first patient using gene therapy to target I-1c to improve heart function is a tremendous milestone not only for the AskBio and NanoCor teams but, more importantly, for patients whose quality of life is negatively affected by CHF, said Jude Samulski, PhD, Chief Scientific Officer and co-founder of AskBio. We initially developed this gene therapy as treatment for late-stage Duchenne muscular dystrophy patients who typically die from cardiomyopathy. Following preclinical studies, we observed that heart function improved, which led us to investigate treatment for all types of heart failure.

Were excited to be involved in this novel approach for patients with Class III heart failure, said Timothy Henry, MD, FACC, MSCAI, Lindner Family Distinguished Chair in Clinical Research and Medical Director of The Carl and Edyth Lindner Center for Research at The Christ Hospital in Cincinnati, Ohio, and principal investigator for the study. These patients currently have no other options besides transplant and left ventricular assist devices (LVAD). Today, we started to explore the potential of gene therapy to change their outcomes.

Heart disease is the leading cause of death worldwide, with CHF affecting an estimated 1% of the Western world, including over six million Americans. There is no cure, and medications and surgical treatments only seek to relieve symptoms and slow further damage.

Research by many investigators around the world has been trying to understand what exactly goes wrong in the heart and weakens its pumping activity until it finally fails, said Evangelia (Litsa) Kranias, PhD, FAHA, Hanna Professor, Distinguished University Research Professor and Director of Cardiovascular Biology at the University of Cincinnati College of Medicine. The aim has been to identify potential therapeutic targets to restore function or prevent further deterioration of the failing heart. Along these lines, research on the role of I-1c started over two decades ago, and it moved from the lab bench to small and large animal models of heart failure. The therapeutic benefits at all levels were impressive. It is thrilling to see I-1c moving into clinical trials with the hope that it also improves heart function in patients with CHF.

About the NAN-101 Clinical Trial NAN-CS101 is a Phase 1 open-label, dose-escalation trial of NAN-101 in subjects with NYHA Class III heart failure. NAN-101 is administered directly to the heart via an intracoronary infusion by cardiac catheterization in a process similar to coronary angioplasty, commonly used to deliver treatments such as stem cells to patients with heart disease. The primary objective of the study is to assess the safety of NAN-101 for the treatment of NYHA Class III heart failure, as well as assess the impact of this treatment on patient health as measured by changes in exercise capacity, heart function and other factors including quality of life.

AskBio is actively enrolling patients with NYHA Class III heart failure to assess three doses of NAN-101. Please refer to clinicaltrials.gov for additional clinical trial information.

Would you like to receive our AskFirst patient engagement program newsletter? Sign up at https://www.askbio.com/patient-advocacy.

About The Christ Hospital Health Network The Christ Hospital Health Network is an acute care hospital located in Mt. Auburn with six ambulatory centers and dozens of offices conveniently located throughout the region. More than 1,200 talented physicians and 6,100 dedicated employees support the Network. Its mission is to improve the health of the community and to create patient value by providing exceptional outcomes, the finest experiences, all in an affordable way. The Network has been recognized by Forbes Magazine as the 24th best large employer in the nation in the magazines Americas 500 Best Large Employers listing and by National Consumer Research as the regions Most Preferred Hospital for more than 22 consecutive years. The Network is dedicated to transforming care by delivering integrated, personalized healthcare through its comprehensive, multi-specialty physician network. The Christ Hospital is among only eight percent of hospitals in the nation to be awarded Magnet recognition for nursing excellence and among the top five percent of hospitals in the country for patient satisfaction. For more than 125 years, The Christ Hospital has provided compassionate care to those it serves.

About AskBioFounded in 2001, Asklepios BioPharmaceutical, Inc. (AskBio) is a privately held, clinical-stage gene therapy company dedicated to improving the lives of children and adults with genetic disorders. AskBios gene therapy platform includes an industry-leading proprietary cell line manufacturing process called Pro10 and an extensive AAV capsid and promoter library. Based in Research Triangle Park, North Carolina, the company has generated hundreds of proprietary third-generation AAV capsids and promoters, several of which have entered clinical testing. An early innovator in the space, the company holds more than 500 patents in areas such as AAV production and chimeric and self-complementary capsids. AskBio maintains a portfolio of clinical programs across a range of neurodegenerative and neuromuscular indications with a current clinical pipeline that includes therapeutics for Pompe disease, limb-girdle muscular dystrophy type 2i/R9 and congestive heart failure, as well as out-licensed clinical indications for hemophilia (Chatham Therapeutics acquired by Takeda) and Duchenne muscular dystrophy (Bamboo Therapeutics acquired by Pfizer). For more information, visit https://www.askbio.com or follow us on LinkedIn.

SOURCE: Asklepios BioPharmaceutical

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AskBio Announces First Patient Dosed in Phase 1 Trial Using AAV Gene Therapy for Congestive Heart Failure | DNA RNA and Cells | News Channels -...

Throughout the United States, stem cell therapy is being touted as a miracle cure for everything from wrinkles to spinal repair.

Though very few of these applications have any scientific backing, stem cell therapy for knees has been the subject of quite a few promising studies.

Arthritis develops when the cartilage lining the joints starts to deteriorate, causing pain and limiting function. Osteoarthritis is incredibly common. Arthritis and similar conditions are a major cause of disability in the United States.

Every year about 600,000 Americans get a knee replacement, a number that could rise to 3 million by 2030. Until recently, treatment options were either temporary or surgical.

Now, in numerous cases, stem cell therapy for knees is reducing pain and repairing cartilage. As a result, many people have been able to improve their quality of life and avoid surgery.

As studies continue, the forms and combinations of stem cell preparations are improving, and outcomes are expected to improve as well.

The job of adult stem cells is to maintain and heal tissues by replenishing damaged and dying cells. In some areas of the body, such as the knee, blood supply is limited, so stem cells dont work as well as they should.

Alternatively, though, they can be injected, at which point they appear to initiate the self-recovery process.

The usual job of joint cartilage is to promote smooth movement of joint surfaces and protect bones from friction. This process allows for shock absorption of up to 20 times the weight of the body. Its essential to physical movement, especially in athletics.

Osteoarthritis is one of the most common chronic degenerative disorders and it very often affects the knee, causing deterioration of its joint cartilage over time.

Osteoarthritis can also begin as a result of a knee injury, such as a ligament tear, tendon damage, or a fracture.

In the face of damage, the joint becomes unstable and this wears down the articular cartilage. From there, the bone can suffer damage as well, in addition to the synovial joint lining, tendons, ligaments, and muscles.

Stem cell therapy for knees is minimally invasive. Its a procedure that can decrease inflammation, slow and repair all these forms of damage from arthritis, and delay or prevent knee replacement surgery.

Adult stem cells can be extracted from bone marrow or fat through simple methods. Its then concentrated and injected into the knee with image guidance, usually to successful results.

In one study, patients experienced improvement in both knees even though only one knee was injected. Although natural deterioration of the knee continues, at five years, those knees that are injected with stem cells are in better shape than they were before the injections.

Researchers believe that stem cell therapy for the knee works by:

Ongoing research is striving to determine which stem cell knee therapy techniques, cell choices, and dosages yield the most effective and consistent results.

While some seem more potent than others and overall results are promising, more research is needed.

Stem cell treatment for knees is noninvasive and rarely painful. Side effects are minimal.

The most frequent experiences after the procedure include mild pain at the injection site, swelling, and some joint stiffness.

A review of multiple medical institutions reveals an average cost for stem cell treatment for knees of approximately $3,000 to $5,000 per knee, depending largely on geographical location.

Most insurance companies dont cover stem cell injections yet, but that may be starting to change as more research accumulates showing the effectiveness of the process.

People typically complete the procedure in one visit, but usually have an initial consultation and a follow-up appointment. The injections take approximately two to three hours.

Although stem cell therapy can pose serious risks when performed on other parts of the body, such as the eyes or the spine, its relatively safe when performed on the knees.

Stem cell therapy using adult stem cells is safest because the stem cells are collected from the persons own body. This reduces the risk of a bad reaction.

Risks are increased if:

Because this is such a new area, new research is released frequently.

While the FDA is closely watching stem cell therapy developments, the only applications that are approved involve embryonic stem cells to treat blood or immune system disorders.

If youre experiencing knee pain or limited knee mobility, alternative initial treatments might include anti-inflammatory medications, opioid pain medications, or physical therapy.

Alternative treatments include injections with platelet-rich plasma, hyaluronic acid, or steroids.

Surgical treatments may be tried as well, such as arthroscopy, subchondral bone drilling, or microfracture.

Stem cell therapy for knees is still very new and the FDA is proceeding with caution, but studies so far are very promising.

Many people have successfully avoided knee surgery and side effects are minimal for this particular body part.

Excerpt from:
Stem Cell Therapy for Knees: Process, Efficacy, and Cost

Feb. 3, 2020 08:48 UTC

CAMBRIDGE & WETHERBY, United Kingdom--(BUSINESS WIRE)-- Avacta Group plc (AIM: AVCT), the developer of Affimer biotherapeutics and reagents, is pleased to announce that it has signed a collaboration and license agreement with AffyXell Therapeutics (AffyXell), the recently established joint venture with Daewoong Pharmaceutical (Daewoong), to develop Affimer proteins to be used by AffyXell for the generation of new cell and gene therapies.

Avacta and AffyXell will now work together to develop Affimer proteins against a range of targets which, when produced by mesenchymal stem cells (MSCs), are intended to inhibit inflammatory and autoimmune pathways and improve the overall efficacy of MSCs, creating a next generation of stem cell therapies.

The initial focus for AffyXell will be on inflammatory and autoimmune diseases. In the longer term, there is potential for AffyXell to address oncology uses for these Affimer-enabled cell and gene therapies.

Under the terms of the collaboration and license agreement, Avactas research and development costs associated with generation of the Affimer proteins will be funded by AffyXell. In addition, Avacta will retain the rights to commercialise the Affimer proteins outside of the field of cell therapies.

Dr Alastair Smith, Chief Executive Officer of Avacta Group, commented: The potential for AffyXells new class of cell therapies, which can be applied to a wide range of inflammatory and autoimmune diseases, is enormous. We are therefore very excited by the opportunity to be part of this new venture and to demonstrate the power of Affimer proteins in the field of engineered cell therapies.

Our objective is for these cell therapies to finally fully address diseases, such as inflammatory bowel diseases and multiple sclerosis, as well as other autoimmune diseases, such as chronic obstructive pulmonary disease. The potential to make a difference in the quality of life for millions of patients continues to inspires us, as we know it does our colleagues at Daewoong as well.

From a commercial perspective, the global stem cell market is expected to be worth USD16bn [1] by 2025. AffyXell has a unique opportunity to combine two world-class technologies, Avactas Affimer antibody mimetic platform and Daewoongs proprietary technology for generating off-the-shelf allogeneic MSC therapies to create the next generation of stem cell therapies. We believe that this has the potential to create substantial value for stakeholders in the near future.

Seng-ho Jeon, CEO of Daewoong Pharmaceutical, commented: We are very excited to contract this Collaboration and License Agreement followed by the successful establishment of an innovative joint venture, AffyXell. Daewoong and Avacta will make every effort to AffyXells growth and its development of distinguished and innovative cell and gene therapy treatment.

As announced at the J.P. Morgan Healthcare Conference this January, Daewoong has been inspired to partner global biotechnology companies like Avacta to create the best and the most comprehensive technology in new drug development field. Starting from our very first cell and gene therapy specialised joint company, we reaffirm our belief that our contract can not only further establish AffyXell to thrive as an leader of cell and gene therapy, but also, allow us to enhance quality of lives to those who suffer from rare and intractable conditions.

[1] https://www.grandviewresearch.com/press-release/global-stem-cells-market

View source version on businesswire.com: https://www.businesswire.com/news/home/20200203005280/en/

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Avacta and Daewoong Agree Collaboration and License Agreement with AffyXell Therapeutics - BioSpace

Published 7:30am EST, Monday, February 3, 2020

Bridges by EPOCH at Trumbull, a memory care assisted living community, located at 2415 Reservoir Ave., will host the following complimentary events in February. Call 203-935-8530 to RSVP.

Dementia Live Experience Thursday, Feb. 6, from 4 to 8 p.m. Presented by Right at Home, Caregivers are invited to reserve a time slot to step inside the body and mind of dementia. This powerful virtual experience will allow caregivers to see, hear and feel what life is like for someone living with dementia. Caregivers may bring their loved ones with memory loss to enjoy an activity with Bridges residents during this seminar. Refreshments will be served.

Caregiver Support Group Wednesday, Feb. 19, at 5:30 p.m. Caregivers are invited to trade tips, socialize with others on a similar journey and receive expert advice from dementia care professionals who understand their challenges and concerns. Dinner will be served. Caregivers may bring their loved ones with memory loss to dine with Bridges residents while they attend the group.

Dine and Discover Stem Cell Therapy for Stroke and Traumatic Brain Injury (TBI) Patients: Thursday, Feb. 20, at 5 p.m.; With Guest Speaker Dr. Peter McAllister, co-founder and Chief Medical Officer, New England Institute for Clinical Research. Stroke and traumatic brain injury strike millions of people each year. Dr. McAllister will discuss the various treatment options for the long-term effects of these conditions, including weakness, spasticity, language and cognitive difficulties and pain. He'll also discuss new research on stem cell therapy that could help restore function for stroke and TBI patients. Caregivers may bring their loved ones with memory loss to enjoy a meal and an activity with Bridges by EPOCH residents during this seminar. Dinner will be served.

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Dementia Live and 'Stem Cell Therapy for Stroke and Traumatic Brain Injury Patients' seminars - Trumbull Times

Hyperbaric oxygen therapy can improve heart functionality in healthy aging humans.This, according to a new study by the Sagol Center for Hyperbaric Medicine and Research at Shamir Medical Center in Beer Yaakov.In this new study, director of the Sagol Center for Hyperbaric Medicine and Research at Shamir Medical Center Professor Shai Efrati and Dr. Marina Leitman, head of the Echocardiography Unit and Non-invasive Cardiology Service at Shamir Medical Center turned their attention to HBOTs impact on cardiac function.According to the center, the study of HBOT for cardiac function has been limited, mostly evaluating patients during and after short-term exposures. However, for the first time, the study was conducted in humans and it demonstrated that repetitive HBOT protocols have a sustained effect on heart function.Healthy patients receiving HBOT to improve cognitive function underwent a 60-session treatment course using the Sagol Centers regenerative HBOT protocols. Using a high-resolution echocardiography, patients were evaluated before HBOT was administered and three weeks after treatment concluded, to identify the sustained effect of the treatment. The study was conducted on 31 patients.Speaking to The Jerusalem Post, Efrati explained that hyperbaric oxygen therapy (HBOT) includes the inhalation of 100% oxygen at pressures exceeding one atmosphere absolute (ATA), which is the average atmospheric pressure exerted at sea level, in order to increase the amount of oxygen dissolved in the body tissues.Efrati, who has been pioneering new approaches for the application of HBOT treatments that specifically focus on HBOTs ability to trigger regeneration in the body, said that in the past HBOT has been applied worldwide mostly for chronic non-healing wounds. In recent years, there is growing evidence on the regenerative effects of HBOT, he said. We have now realized that the combined action of both hyperoxia (an excess of oxygen in the body) and hyperbaric pressure, leads to significant improvement in tissue oxygenation while targeting both oxygen and pressure sensitive genes, resulting in improved mitochondrial metabolism with anti-apoptotic (anti-cell death) and anti-inflammatory effects.According to Efrati, the newly developed protocols used in this study, which includes the intermittent increasing and decreasing of oxygen concentration, induces what is known as the Hyperoxic Hypoxic Paradox. This, he said induces stem cells proliferation and mobilization, leading to the generation of new blood vessels (angiogenesis) and tissue regeneration.Efrati said that during the first studies they conducted at the Sagol Center, they evaluated the beneficial effects of HBOT on brain injuries due to traumatic brain injury and stroke. However, in this study we evaluated for the first time the effect of these new regenerative HBOT protocols on the normal aging heart. For the first time in humans we have demonstrated that HBOT can improve cardiac function.Asked about what inspired the research, Efrati said that for over the last 12 years the team has developed an ongoing research program that investigates the regenerative effects of HBOT on different issues and degrees of damage. At the beginning we were focused on non-healing peripheral wounds, he said. Then, we turned our focus to certain types of brain injuries. However, once the researchers found that HBOT induced many of the essential elements crucial to repairing almost any mechanism, we initiated a complementary research program that targets other organs such as the heart and other elements related to expected age-related functional decline.Addressing the significance of this research, Efrati said that along with normal aging, there is typically a decrease in cardiac function particularly in the mitochondrial cells of the heart. The mitochondria are the powerhouse of the cell [and] this is where we create energy, he pointed out. HBOTs ability to improve mitochondrial function may explain the beneficial effects that we saw in the cardiac function of this normal aging population. By exposing the mitochondria to the fluctuations in oxygen by the use of HBOT, the team observed an improvement in contractility function of the heart meaning, the heart muscle contracted more efficiency over the course of the 60-session protocol. Efrati highlighted that the effect was particularly evident in the left ventricle, which is the chamber responsible for pumping oxygenated blood to the rest of the body. This is only the beginning of our understanding of the impact of HBOT on cardiac function in a normally aging population, and a larger and more diverse cohort will be required to further evaluate our initial findings, he said.Asked whether this treatment could also be used on people who are predisposed to heart conditions, Efrati said that the short answer is yes, but stressed that more research is needed.As far as we know, we are the first to identify HBOTs ability to improve cardiac function, he told the Post. Our study was on a group of 31 asymptomatic normal aging heart patients. We believe it is important to expand the scope of this study to a larger group, with both symptomatic and asymptomatic patients to understand the possibilities for HBOT as a treatment for patients with heart-related diseases, he emphasized.The Sagol Center has also been studying the impact of HBOT on a variety of cognitive conditions. We have also conducted studies which showed positive results for the treatment of post-concussion syndrome as a result of traumatic brain injury, post-stroke recovery, fibromyalgia, adding that today, medical professionals understand that fibromyalgia is linked to issues in the brain center responsible for pain interpretation. He made it clear that not every patient will benefit from HBOT, which is why patient selection should be done very carefully based on the damage seen in brain imaging assessments.For example, if someone has a stroke, some of the tissue at the core of the stroke will die we will not be able to recover this tissue, Efrati continued. But, other tissue that is damaged but not fully dead... is where HBOT can help. This damaged tissue, known as the metabolic dysfunction tissue (penumbra), is where we can have an impact and help recover lost function, he added.On the timeline as to when using HBOT protocols may be put into effect on healthy aging patients in Israel, Efrati said that these studies are already ongoing. I cant speak too much about this, as we are in the process of developing the results of the first study for publication, he said. However, we believe HBOT can positively impact both cognitive and physical performance in aging adults based on what we have seen at this point.Efrati said that they will continue pursuing this line of research as it has the ability to transform how we look at aging. Looking at 2020 and beyond, Efrati said that they have a number of research collaborations that are ongoing, including research on cognitive decline, fibromyalgia and PTSD. In addition, we have an ongoing research program on athletic performance both in professional and amateur level athletes, which looks at how HBOT may further improve performance, he said. Finally, we are studying the impact of HBOT on healthy aging adults to understand how HBOT may improve our health and cognitive performance as we age.Concluding, Efrati pointed out that when you look at aging as a disease that can be measured, then it can be treated, and this is a serious area of investigation for us.The study was led by Marina Leitman, MD; Shmuel Fuchs, MD; Amir Hadanny, MD; Zvi Vered, MD; and Efrati. It was published in The International Journal of Cardiovascular Imaging.

Continued here:
Hyperbaric oxygen therapy improves heart function in healthy, aging people - The Jerusalem Post

When Bellicum Pharmaceuticals built the cell therapy plant in Houston, Texas, it planned to use the US site to support its early-phase chimeric antigen receptor (CAR)-T trials and late-phase development and commercialization of Rivo-cel (rivogenlecleucel), a drug designed to improve hematopoietic stem cell transplantation outcomes.

A registrational trial of Rivo-cel met its primary endpoint in July 2019, leading Bellicum to start looking for a partner for the asset. However, the search for a partner did not go as well as Bellicum hoped.

By November, Bellicum CEO Rick Fair was warning investors that it's unclear if an agreement [for Rivo-cel] will be reached. Bellicum responded to the uncertainty by pausing work in the area.

That decision about Rivo-cel had a knock-on effect on the viability of Bellicums manufacturing facility.

Fair said, Given our decisions on Rivo-cel, our facility is substantially underutilized with a significant fixed cost base. We are actively pursuing a partner for the facility with the goals of reducing operating costs while maintaining critical viral vector and cell therapy development capabilities and dedicated manufacturing capacity.

Bellicums pursuit of a partner led it to The University of Texas MD Anderson Cancer Center. In return for $15m (13.5m), MD Anderson is set to buy the 60,000-square-foot facility, giving it production capacity to support its own cell therapies and those of its strategic partners.

The deal features a master services agreement intended to ensure Bellicum can access cell therapy manufacturing capacity despite no longer having an in-house facility. MD Anderson will make CAR-Ts and other cell therapies for use in Bellicums clinical trials, plus potentially early commercial supply, from the Houston facility on a service basis.

To smooth the transition, around 35 Bellicum employees based at the facility are set to start working for MD Anderson once the deal goes through. Bellicum expects to close the deal in the first quarter.

MD Anderson will use the capacity not taken up by Bellicums assets to support its own programs and those of its partners. The US cancer center has been at the forefront of efforts to develop and deploy cell therapies, creating a need for manufacturing capacity to support the work of its discovery division.

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Bellicum offloads cell therapy plant in switch to outsourced production - OutSourcing-Pharma.com