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Clene Announces Plans to Submit Briefing Book to the U.S. Food and Drug Administration in Connection with Granted Type C Interaction to Obtain FDA…

By Stell Cell Research

SALT LAKE CITY, July 11, 2024 (GLOBE NEWSWIRE) -- Clene Inc. (Nasdaq: CLNN) (along with its subsidiaries, “Clene”) and its wholly owned subsidiary Clene Nanomedicine Inc., a clinical-stage biopharmaceutical company focused on improving mitochondrial health and protecting neuronal function to treat neurodegenerative diseases, including amyotrophic lateral sclerosis (ALS) and multiple sclerosis (MS), today announced plans to submit a briefing book by July 13 to the U.S. Food and Drug Administration (FDA) in advance of a granted Type C interaction. The purpose of the interaction with the FDA, to occur in the third quarter of 2024, is to receive feedback on the potential path to submission of a new drug application (NDA) for CNM-Au8® as a potential treatment for ALS via the accelerated approval pathway.

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Clene Announces Plans to Submit Briefing Book to the U.S. Food and Drug Administration in Connection with Granted Type C Interaction to Obtain FDA...

Myriad Genetics and Personalis Cross-License Foundational MRD Intellectual Property to Broaden Patient Access to Testing

By Stell Cell Research

SALT LAKE CITY and FREMONT, Calif., July 11, 2024 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc. (Nasdaq: MYGN), a leader in genetic testing and precision medicine, and Personalis, Inc. (Nasdaq: PSNL) today announced that they have entered into an agreement to cross-license patent estates covering tumor-informed approaches to detect minimal residual disease (MRD). The agreement helps solidify each company’s freedom to operate in the MRD market and broadens patient access to the benefits of MRD testing.

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Myriad Genetics and Personalis Cross-License Foundational MRD Intellectual Property to Broaden Patient Access to Testing

CervoMed to Host Virtual KOL Event on Neflamapimod for Dementia with Lewy Bodies on July 23, 2024

By Stell Cell Research

BOSTON, July 11, 2024 (GLOBE NEWSWIRE) -- CervoMed Inc. (NASDAQ: CRVO), a clinical stage company focused on developing treatments for age-related neurologic disorders, today announced that it will host a virtual key opinion leader (KOL) event on Tuesday, July 23, 2024 at 10:00 AM ET.

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CervoMed to Host Virtual KOL Event on Neflamapimod for Dementia with Lewy Bodies on July 23, 2024

Rhythm Pharmaceuticals Announces New Employment Inducement Grants

By Stell Cell Research

BOSTON, July 11, 2024 (GLOBE NEWSWIRE) -- Rhythm Pharmaceuticals, Inc. (Nasdaq: RYTM), a commercial-stage biopharmaceutical company focused on transforming the lives of patients and their families living with rare neuroendocrine diseases, today announced that on July 8, 2024, the Compensation & Management Development Committee of Rhythm’s Board of Directors granted inducement restricted stock units, or RSUs, covering an aggregate of 19,200 shares of its common stock to six new employees.

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Rhythm Pharmaceuticals Announces New Employment Inducement Grants

Stem Cells Market Driven by Tech Integration and Innovation – openPR

By Stell Cell Research

The global stem cells market is witnessing unprecedented growth, driven by advancements in medical research and increasing acceptance of stem cell therapies. This report delves into the key highlights of the market, analyzing trends, investments, and future prospects that are shaping this dynamic sector.

Market Revenue and Growth Projections

The global stem cells market is on a robust growth trajectory. By 2032, the market is projected to increase by an impressive USD 37.8 billion. This substantial growth is underpinned by a compound annual growth rate (CAGR) of 11.3% from 2023 to 2032. Such a significant CAGR indicates strong market confidence and the potential for continued expansion as more breakthroughs in stem cell research and applications emerge.

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Regional Market Leaders

In 2022, North America dominated the global stem cells market, commanding over 43% of the market share. This leadership position is largely attributed to the extensive research infrastructure, significant funding, and early adoption of advanced medical technologies in the region. The presence of leading research institutions and biotechnology companies in North America further consolidates its market dominance.

Investment in Stem Cell Research

A critical driver of the stem cells market is the substantial investment in research and development. In 2019, the US National Institutes of Health (NIH) invested over $1.5 billion in stem cell research, making it the largest funder globally. This level of investment underscores the importance of stem cells in medical research and the commitment of the US government to advancing this field. The NIH's funding supports a wide range of projects, from basic science to clinical trials, thereby fostering innovation and accelerating the translation of research findings into clinical applications.

Increase in Clinical Trials

The number of clinical trials utilizing stem cells has been steadily increasing over the past decade. By 2020, there were over 5,000 active stem cell trials worldwide. This surge in clinical trials is indicative of the growing confidence in stem cell therapies and their potential to revolutionize medical treatments. Clinical trials are essential for evaluating the safety and efficacy of new therapies, and the high number of ongoing trials suggests a vibrant and active research community working towards bringing new stem cell-based treatments to market.

Therapeutic Potential of Stem Cells

Stem cells hold immense potential for treating a variety of diseases and injuries. According to the NIH, stem cells could be instrumental in treating conditions such as cancer, diabetes, heart disease, and Parkinson's disease. This wide-ranging therapeutic potential is one of the key factors driving investment and research in the field. Stem cells' ability to differentiate into various cell types makes them versatile tools in regenerative medicine, offering hope for treatments that can repair or replace damaged tissues and organs.

Rising Awareness and Acceptance

Another significant factor contributing to the growth of the stem cells market is the rising awareness and acceptance of stem cell therapies. As more research validates the efficacy and safety of these treatments, public and professional acceptance is increasing. This growing acceptance is crucial for market expansion, as it encourages more patients to seek stem cell therapies and more healthcare providers to offer these innovative treatments.

Stem Cells Market Segmentation

Stem Cells Market By Product Adult Stem Cells o Dental Stem Cells o Neuronal Stem Cells o Adipose-derived Stem Cells o Mesenchymal Stem Cells o Dedifferentiated fat (DFAT) Cells o HematopoieticStem Cells o Umbilical Cord Stem Cells o Other ASC's Human Embryonic Stem Cells Very Small Embryonic Like Stem Cells Induced Pluripotent Stem Cells

Stem Cells Market By Application Regenerative Medicine o Oncology o Hematology o Neurology o Injuries o Liver Disorder o Incontinence o Diabetes o Orthopedics o Others Drug Discovery and development

Stem Cells Market By Technology Cryopreservation Cell Acquisition o Bone Marrow Harvest o Apheresis o Umbilical Blood Cord Cell production o Isolation o Therapeutic Cloning o In-Vitro fertilization o Cell Culture Expansion and Sub-Culture

Stem Cells Market By Therapy Autologous Stem Cell Therapy Allogenic Stem Cell Therapy

Future Prospects and Challenges

Looking ahead, the future of the stem cells market appears promising, with continued growth anticipated. However, the market also faces several challenges. Regulatory hurdles, ethical concerns, and the high cost of stem cell therapies are significant barriers that need to be addressed. The regulatory landscape for stem cell treatments is complex and varies significantly across different countries, which can slow down the approval and commercialization of new therapies. Ethical issues related to the use of embryonic stem cells also pose challenges, although the development of induced pluripotent stem cells (iPSCs) has mitigated some of these concerns.

Moreover, the high cost of developing and administering stem cell therapies can limit their accessibility. Ensuring that these therapies are affordable and accessible to a broad patient population will be crucial for the long-term success of the market.

Stem Cells Market Table of Content:

CHAPTER 1. Industry Overview of Stem Cells Market CHAPTER 2. Research Approach CHAPTER 3. Market Dynamics And Competition Analysis CHAPTER 4. Manufacturing Plant Analysis CHAPTER 5. Stem Cells Market By Product CHAPTER 6. Stem Cells Market By Application CHAPTER 7. Stem Cells Market By Technology CHAPTER 8. Stem Cells Market By Therapy CHAPTER 9. North America Stem Cells Market By Country CHAPTER 10. Europe Stem Cells Market By Country CHAPTER 11. Asia Pacific Stem Cells Market By Country CHAPTER 12. Latin America Stem Cells Market By Country CHAPTER 13. Middle East & Africa Stem Cells Market By Country CHAPTER 14. Player Analysis Of Stem Cells Market CHAPTER 15. Company Profile

Conclusion

In conclusion, the global stem cells market is set for significant growth, driven by substantial investments, increasing clinical trials, and the expanding therapeutic potential of stem cells. North America remains at the forefront of this market, supported by strong research funding and infrastructure. While the market faces challenges, particularly in regulatory and ethical domains, the overall outlook is positive. Continued advancements in research and increasing acceptance of stem cell therapies promise to unlock new possibilities in medical treatment, potentially transforming the landscape of healthcare in the coming decades.

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This release was published on openPR.

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Stem Cells Market Driven by Tech Integration and Innovation - openPR

World’s first diabetes cure with cell therapy achieved in China – Interesting Engineering

By Stell Cell Research

In a groundbreaking medical achievement, a team of Chinese scientists and clinicians has reportedly cured a patient of diabetes using cell therapy for the first time.

The patient, a 59-year-old man who had endured type 2 diabetes for 25 years, faced severe complications from the disease. Despite receiving a kidney transplant in 2017, he had lost most of his pancreatic islet function, which is crucial for regulating blood glucose levels, and was dependent on multiple daily insulin injections.

I think this study represents an important advance in the field of cell therapy for diabetes, Timothy Kieffer, a professor in the Department of Cellular and Physiological Sciences at the University of British Columbia, told South China Morning Post (SCMP) on Monday.

Global researchers are investigating islet transplants as a promising alternative treatment, primarily focusing on creating islet-like cells from human stem cell cultures. After more than a decade of effort, the Chinese team has made significant progress.

In July 2021, the patient underwent the cell transplant. Just 11 weeks later, he no longer required external insulin, and within a year, his need for oral medication to control blood sugar levels was completely eliminated.

The team, led by Yin Hao, a leading researcher at Shanghai Changzheng Hospital, used and programmed the patients own peripheral blood mononuclear cells. These were transformed into seed cells and reconstituted pancreatic islet tissue in an artificial environment.

Yin emphasized that this breakthrough is another advancement in the field of regenerative medicine, which leverages the bodys own regenerative capabilities to treat illness.

A common challenge in translational research is differentiating stem cells into high-quality insulin-producing cells on a large scale for therapeutic use. In a study published in Stem Cell Research & Therapy earlier this year, a team of diabetes researchers led by Kieffer explored methods to enhance scalable manufacturing.

They identified key parameters for monitoring quality during cell therapy production. Their findings offer valuable insights into the large-scale production of human pluripotent stem cell (hPSC)-derived pancreatic cells and propose ways to standardize the manufacturing process.

While preclinical data from Kieffers team supports using stem cell-derived islets for type 2 diabetes treatment, Yins report represents the first evidence in humans, according to Kieffer.

Chinas diabetic population is disproportionately high, notes Huang Yanzhong, a senior fellow for global health at the Council on Foreign Relations. He highlighted that although China comprises 17.7% of the worlds population, its diabetic population constitutes a staggering quarter of the global total, imposing a significant health burden on the government.

China has the highest number of people with diabetes globally. According to the International Diabetes Federation, the country has 140 million people with diabetes, with around 40 million of them dependent on lifelong insulin injections.

If this cell therapy approach proves successful, Kieffer told SCMP that, it can free patients from the burden of chronic medications, improve health and quality of life, and reduce healthcare expenditures.

However, he emphasized that further studies involving more patients, based on the findings of this Chinese study, are necessary to achieve these outcomes.

NEWSLETTER

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Srishti Gupta Srishti studied English literature at the University of Delhi and has since then realized it's not her cup of tea. She has been an editor in every space and content type imaginable, from children's books to journal articles. She enjoys popular culture, reading contemporary fiction and nonfiction, crafts, and spending time with her cats. With a keen interest in science, Srishti is particularly drawn to beats covering medicine, sustainability, gene studies, and anything biology-related.

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World's first diabetes cure with cell therapy achieved in China - Interesting Engineering

Frederick biotech Theradaptive secures $1M in funding from MD Stem Cell Research Fund for human clinical trials – Maryland Daily Record

By Stell Cell Research

Theradaptive Inc., a regenerative medicine company developing targeted therapeutics, Wednesday was awarded $1 million from the Maryland Stem Cell Research Fund (MSCRF) to support human clinical trials for its lead product, OsteoAdapt SP.

OsteoAdapt SP is currently in Phase I/II clinical studies for transforaminal lumbar interbody spinal fusion (TLIF) to treat degenerative disc disease, spondylolisthesis, and retrolisthesis.

Theradaptive was granted an Investigational Device Exemption (IDE) inJanuary by the U.S. Food and Drug Administration (FDA) to begin its human clinical trial. The award from the MSCRF Clinical Program will enable Theradaptive to expand its OASIS human clinical study to sites inMaryland.

OsteoAdapt SP is a biologic-enhanced implant designed to stimulate anatomically precise local bone growth and promote rapid fusion following spinal surgery. It combines a proprietary protein called AMP2 that activates a patients own stem cells with a resorbable scaffold implant.

This implant remodels into bone and completely resorbs, leaving no trace behind. This technology ushers in the next generation of regenerative therapeutics compared to the current standard of care by mitigating side effects and significantly improving safety and efficacy over traditional bone grafts and biologics.

The company was spun out of theMassachusetts Institute of Technologyin 2017 to commercialize a platform that immobilizes therapeutic proteins on implantable biomaterials. The companys near-term focus is on regenerative treatments for musculoskeletal conditions and spinal fusion surgery.

Clinical sites investigating OsteoAdapt SP in TLIF procedures are currently enrolling patients in Maryland and across the United States and inAustralia.

Theradaptive plans to file for marketing authorization with the U.S. Food and Drug Administration following successful completion of pivotal clinical studies.

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Frederick biotech Theradaptive secures $1M in funding from MD Stem Cell Research Fund for human clinical trials - Maryland Daily Record

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