University and community guests recently gathered to celebrate the 7,700 square-foot Good Manufacturing Practice facilitys grand opening in Hewitt Halls basement on the UC Irvine campus. Although the highly sterile environment remains off-limits for tours, the gala highlighted its importance to the campus, the UC system and the local community.

This facility is not just a building; it is a powerhouse of innovation and hope, meticulously designed and equipped to produce FDA-compliant cell and gene therapies, which are at the forefront of medical sciences promise for the future, says Dr. Michael J. Stamos, dean of the UC Irvine School of Medicine. It symbolizes our commitment to developing advanced treatments for neurological diseases and cancers that position us at the forefront of translational research, clinical trials and patient services, that were once deemed unattainable.

The facility is primarily dedicated to producing cell and gene products that meet stringent GMP regulations enforced by the FDA. In addition, researchers and scientists will use next-generation automated processing and manufacturing technologies, supplemented by leading-edge analytical tools, to produce the transformative therapies essential for clinical trials.

A collaborative effort

The School of Medicine, the Susan & Henry Samueli College of Health Sciences, the Sue & Bill Gross Stem Cell Research Center and the Chao Family Comprehensive Cancer Center and other campus partners have dedicated more than $12 million to the facility.

Our commitment to taking a multidisciplinary approach to integrating groundbreaking research with clinical applications was also recognized and supported by the California Institute for Regenerative Medicine, says Aileen Anderson, Ph.D., director of the UC Irvine Stem Cell Research Center and professor of physical medicine & rehabilitation. We were awarded an initial two-year, $2 million grant to help launch this project, along with membership in the prestigious CIRM Cell and Gene Therapy Manufacturing Network.

Next-generation treatments

The GMP facility has a seven-room cellular therapy and viral vector production area, an adjacent quality control laboratory, and a storage warehouse for raw and finished products. It is designed to create FDA-approved stem cell, engineered chimeric antigen receptor T-cell and gene products for clinical research and treatment across multiple medical disciplines.

These potentially pioneering therapies require meticulous production and processing to meet the complex needs of current clinical trials, enhance delivery and improve patient outcomes. They target a range of conditions, including neurological diseases, spinal cord injuries, autoimmune diseases like multiple sclerosis and lupus, and cancers such as leukemia and lymphoma.

Workforce development

In addition to advancing treatment options, the facility will provide educational opportunities and hands-on experience in GMP processes to prepare the next generation of scientists and clinicians who will lead the development of innovations in regenerative medicine.

By fostering interdisciplinary collaboration, investing in state-of-the-art technology and focusing on comprehensive training, our new facility demonstrates the universitys commitment to translational research and clinical excellence that will offer new treatment options for patients worldwide who will benefit from these groundbreaking discoveries, Stamos says.

If you want to learn more about supporting this or other activities at UC Irvine, please visit the Brilliant Future website. By engaging 75,000 alumni and garnering $2 billion in philanthropic investment, UC Irvine seeks to reach new heights of excellence instudent success,health and wellness, research and more. The School of Medicine plays a vital role in the success of the campaign. Learn more by visiting https://brilliantfuture.uci.edu/uci-school-of-medicine/.

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Advancing regenerative medicine therapies UCI News - UCI News

image:

The kidney contains macula densa cells (green/yellow), which orchestrate kidney regeneration. The circulating plasma is labeled white/gray, and all kidney cells are labeled by their production of genetically inserted green and red fluorescent proteins

Credit: Georgina Gyarmati, MD, PhD Zilkha Neurogenetic Institute

A loss of salt and body fluid can stimulate kidney regeneration and repair in mice, according to a NIH-funded study led by USC Stem Cell scientist Janos Peti-Peterdi and published inThe Journal of Clinical Investigation. This innate regenerative response relies on a small population of kidney cells in a region known as the macula densa (MD), which senses salt and exerts control over filtration, hormone secretion, and other key functions of this vital organ.

Our personal and professional mission is to find a cure for kidney disease, a growing global epidemic affecting one out of seven adults, which translates to 850 million people worldwide or about 2 million in the Los Angeles area, said Peti-Peterdi,a professor of physiology, neuroscience and medicine at theKeck School of Medicine of USC. Currently, there is no cure for this silent disease. By the time kidney disease is diagnosed, the kidneys are irreversibly damaged and ultimately need replacement therapies, such as dialysis or transplantation.

To address this growing epidemic, Peti-Peterdi, first author Georgina Gyarmati, and their colleagues took a highly non-traditional approach. As opposed to studying how diseased kidneys fail to regenerate, the scientists focused on how healthy kidneys originally evolved.

From an evolutionary biology perspective, the primitive kidney structure of the fish turned into more complicated and more efficiently working kidneys to absorb more salt and water, said Peti-Peterdi, who also directs the Multi-Photon Microscopy Core at the Zilkha Neurogenetic Institute (ZNI). This was necessary for adaptation to the dry land environment when the animal species moved from the salt-rich seawater. And thats why birds and mammals have developed MD cells and this beautiful, bigger, and more efficient kidney structure to maintain themselves and functionally adapt to survive. These are the mechanisms that we are targeting and trying to mimic in our research approach.

With this evolutionary history in mind, the research team fed lab mice a very low salt diet, along with a commonly prescribed drug called an ACE inhibitor that furthered lowered salt and fluid levels. The mice followed this regimen for up to two weeks, since extremely low salt diets can trigger serious health problems if continued long term.

In the region of the MD, the scientists observed regenerative activity, which they could block by administering drugs that interfered with signals sent by the MD. This underscored the MDs key role in orchestrating regeneration.

When the scientists furthered analyzed mouse MD cells, they identified both genetic and structural characteristics that were surprisingly similar to nerve cells. This is an interesting finding, because nerve cells play a key role in regulating the regeneration of other organs such as the skin.

In the mouse MD cells, the scientists also identified specific signals from certain genes, including Wnt, NGFR, and CCN1, which could be enhanced by a low-salt diet to regenerate kidney structure and function. In keeping with these findings in mice, the activity of CCN1 was found to be greatly reduced in patients with chronic kidney disease (CKD).

To test the therapeutic potential of these discoveries, the scientists administered CCN1 to mice with a type of CKD known asfocal segmental glomerulosclerosis.They also treated these mice with MD cells grown in low-salt conditions. Both approaches were successful, with the MD cell treatment producing the biggest improvements in kidney structure and function. This might be due to the MD cells secreting not only CCN1, but also additional unknown factors that promote kidney regeneration.

We feel very strongly about the importance of this new way of thinking about kidney repair and regeneration, said Peti-Peterdi. And we are fully convinced that this will hopefully end up soon in a very powerful and new therapeutic approach.

Additional co-authors are Urvi Nikhil Shroff, Anne Riquier-Brison, Dorinne Desposito, Audrey Izuhara, Sachin Deepak, Alejandra Becerra Calderon, James L. Burford, Hiroyuki Kadoya, Ju-Young Moon, Yibu Chen, Nariman Ahmadi, Berislav V. Zlokovic, and Inderbir S. Gill from USC; Wenjun Ju and Matthias Kretzler from the University of Michigan; Sean D. Stocker from the University of Pittsburgh School of Medicine; Markus M. Rinschen from the University of Cologne; Lester Lau from the University of Illinois at Chicago; Daniel Biemesderfer from Yale University School of Medicine; Aaron W. James from Johns Hopkins University; and Liliana Minichiello from the University of Oxford.

This work was federally funded by the National Institutes of Health (grants DK064324, DK123564, DK135290, S10OD021833, and 2P30-DK-081943) and further supported by an American Heart Association predoctoral research fellowship (grant 19PRE34380886).

Disclosure: Peti-Peterdi andGyarmatiare cofounders of Macula Densa Cell LLC, a biotechnology company that develops therapeutics to target MD cells for a regenerative treatment for CKD. Macula Densa Cell LLC has a patent entitled Targeting macula densa cells as a new therapeutic approach for kidney disease (US patents 10,828,374 and 11,318,209). Gill declares equity interest in OneLine Health and Karkinos.

Journal of Clinical Investigation

Experimental study

Animals

Neuronally differentiated macula densa cells regulate tissue remodeling and regeneration in the kidney

10-Apr-2024

Peti-Peterdi and Gyarmati are cofounders of Macula Densa Cell LLC, a biotechnology company that develops therapeutics to target MD cells for a regenerative treatment for CKD. Macula Densa Cell LLC has a patent entitled Targeting macula densa cells as a new therapeutic approach for kidney disease (US patents 10,828,374 and 11,318,209). Gill declares equity interest in OneLine Health and Karkinos.

Disclaimer: AAAS and EurekAlert! are not responsible for the accuracy of news releases posted to EurekAlert! by contributing institutions or for the use of any information through the EurekAlert system.

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To regenerate the kidney, please don't pass the salt - EurekAlert

Cell Therapy Market Outlook

The cell therapy market was valued at USD 16.30 billion in 2023, driven by the rising burden of chronic diseases and increased funding for cell therapy clinical studies across the globe. The market is expected to grow at a CAGR of 18.1% during the forecast period of 2024-2032, with the values likely to reach USD 72.84 billion by 2032.

Cell Therapy: Introduction

Cell therapy is a cutting-edge biomedical technology that involves the transplantation of human cells to replace or repair damaged tissues and organs, offering promising treatments for a variety of diseases and injuries. Utilizing stem cells, immune cells, and other specialized cells, this innovative approach targets conditions such as cancer, cardiovascular diseases, neurodegenerative disorders, and autoimmune diseases. By harnessing the body's intrinsic healing mechanisms, cell therapy aims to restore normal function, improve patient outcomes, and enhance quality of life. Rapid advancements in research and clinical trials continue to expand its potential, positioning cell therapy at the forefront of personalized medicine and regenerative healthcare.

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Key Trends in the Global Cell Therapy Market

Key trends in the global cell therapy market include:

Advancements in Manufacturing: Continuous improvements in cell manufacturing processes, including automation and scalability, are enhancing production efficiency and reducing costs.

Regulatory Developments: Evolving regulatory frameworks are shaping the landscape of cell therapy development and commercialization, with efforts to streamline approval processes and ensure patient safety. Increasing Investment: Rising investment from both public and private sectors is fueling research and development activities, driving innovation and expanding the scope of cell therapy applications.

Expansion of Indications: Cell therapies are being explored for a growing range of indications beyond oncology, including cardiovascular diseases, autoimmune disorders, and degenerative conditions. Collaboration and Partnerships: Collaborative efforts between industry players, academic institutions, and government agencies are facilitating knowledge sharing, resource pooling, and the acceleration of clinical development programs.

Personalized Medicine: Advances in cell characterization and patient-specific therapies are enabling the development of personalized treatment approaches tailored to individual genetic profiles and disease characteristics. Commercialization Challenges: Despite promising clinical outcomes, challenges such as reimbursement issues, manufacturing complexities, and market access barriers continue to pose hurdles to the widespread adoption and commercial success of cell therapies. Global Market Expansion: The global cell therapy market is witnessing geographical expansion, with increasing adoption and investment in emerging markets, particularly in Asia-Pacific regions.

Integration of Cell Therapy with Other Modalities: Integration of cell therapy with complementary treatment modalities, such as gene editing and tissue engineering, is unlocking new therapeutic possibilities and synergistic effects. Patient Access and Affordability: Efforts to address concerns related to patient access, affordability, and equitable distribution of cell therapies are gaining prominence, with initiatives aimed at improving healthcare infrastructure and increasing affordability for patients worldwide. Cell Therapy Market Segmentation

Market Breakup by Type

Stem Cell Bone Marrow Derived Mesenchymal Stem Cell Hematopoietic Stem Cells Umbilical Cord Derived Stem Cell Adipose Derived Stem Cell Skin Stem Cells Induced Pluripotent Stem Cells Others Non-Stem Cell (Dendritic Cell, CART-Cell)

Market Breakup by Type of Therapy

Autologous Allogeneic

Market Breakup by Therapeutic Area

Musculoskeletal Disorders Cardiovascular Diseases Neurological Disorders Oncological Disorders Dermatology Inflammatory and Autoimmune Disorders Others

Market Breakup by End User

Hospitals and Clinics Regenerative Medicine Centers Diagnostic and Research Centers Others

Market Breakup by Region

North America Europe Asia Pacific Latin America Middle East and Africa

Read Full Report with Table of Contents- https://www.expertmarketresearch.com/reports/cell-therapy-market

Cell Therapy Market Overview

The global cell therapy market is experiencing significant growth, driven by advancements in biomedical research, increasing prevalence of chronic diseases, and a rising focus on personalized medicine. Cell therapy, which involves the transplantation of human cells to repair or replace damaged tissues and organs, has emerged as a revolutionary approach in treating various conditions, including cancer, cardiovascular diseases, neurodegenerative disorders, and autoimmune diseases.

North America holds a dominant position in the cell therapy market, primarily due to robust healthcare infrastructure, high investment in research and development, and supportive regulatory frameworks. The United States, in particular, is a key player, with numerous biotech companies, research institutions, and clinical trials contributing to the market's expansion. The presence of well-established healthcare facilities and increasing awareness about advanced therapies among patients further bolster the market in this region.

Europe is another significant market for cell therapy, characterized by strong government support and extensive research activities. Countries like Germany, the United Kingdom, and France are leading contributors, driven by a high prevalence of chronic diseases and a growing elderly population. The European Medicines Agency (EMA) provides a conducive regulatory environment, encouraging the development and commercialization of innovative cell-based treatments. Additionally, collaborations between academic institutions and biopharmaceutical companies are propelling market growth in Europe.

The Asia Pacific region is witnessing rapid growth in the cell therapy market, fueled by increasing investments in healthcare infrastructure, rising disposable incomes, and growing awareness about advanced medical treatments. Countries such as Japan, China, and South Korea are at the forefront, with substantial government funding and strategic initiatives to promote regenerative medicine. Japan, in particular, has been a pioneer in cell therapy, with a strong focus on research and clinical applications. The region's large patient pool, coupled with an expanding biotechnology sector, presents significant opportunities for market players.

In Latin America, the cell therapy market is gradually gaining traction, driven by improving healthcare facilities and growing investments in medical research. Brazil and Mexico are key markets in this region, with an increasing number of clinical trials and research programs aimed at exploring the potential of cell-based therapies. Despite facing challenges such as limited funding and regulatory hurdles, the region is poised for growth as awareness about cell therapy continues to rise and technological advancements become more accessible.

The Middle East and Africa region is also emerging as a potential market for cell therapy, albeit at a slower pace compared to other regions. Countries like Israel, the United Arab Emirates, and South Africa are investing in healthcare infrastructure and research initiatives to explore the benefits of regenerative medicine. However, the market's growth in this region is hindered by economic constraints, limited access to advanced medical technologies, and regulatory challenges. Nevertheless, ongoing efforts to improve healthcare services and increasing international collaborations are expected to drive future growth in the cell therapy market.

Cell Therapy Market: Competitor Landscape

The key features of the market report include patent analysis, grants analysis, clinical trials analysis, funding and investment analysis, partnerships, and collaborations analysis by the leading key players. The major companies in the market are as follows:

Vericel Corporation

Vericel Corporation is a biopharmaceutical company specializing in advanced cell therapies for the treatment of serious medical conditions. Headquartered in the United States, Vericel focuses on developing innovative therapies derived from a patient's own cells to address unmet needs in areas such as orthopedics and dermatology. Their flagship products include MACI, a cell-based treatment for cartilage defects in the knee, and Epicel, a cultured epidermal autograft for severe burns. With a commitment to scientific excellence and patient care, Vericel continues to advance the field of regenerative medicine through research, development, and commercialization of transformative cell-based therapies.

Kolon TissueGene Inc.

Kolon TissueGene Inc is a biotechnology company specializing in regenerative medicine and cell therapy. Founded in South Korea, it focuses on developing innovative treatments for orthopedic and neurological disorders. The company's flagship product, Invossa, is the world's first cell-mediated gene therapy for osteoarthritis, offering a potentially transformative approach to disease management. Kolon TissueGene Inc is committed to advancing the field of regenerative medicine through cutting-edge research, strategic partnerships, and a dedication to improving patient outcomes. With a focus on addressing unmet medical needs, the company aims to revolutionize the treatment landscape for a range of debilitating conditions.

JCR Pharmaceuticals Co. Ltd

JCR Pharmaceuticals Co. Ltd is a leading biopharmaceutical company based in Japan, specializing in the development, manufacturing, and commercialization of innovative therapeutics and medical devices. With a focus on rare diseases, oncology, and regenerative medicine, JCR Pharmaceuticals is committed to advancing healthcare through cutting-edge research and development efforts. The company leverages its expertise in biologics and recombinant protein technologies to bring novel treatments to patients worldwide. Through strategic partnerships and collaborations, JCR Pharmaceuticals aims to address unmet medical needs and improve the quality of life for patients across a wide range of therapeutic areas.

MEDIPOST Co. Ltd.

MEDIPOST Co. Ltd. is a leading biotechnology company headquartered in South Korea, specializing in the development and commercialization of innovative cell therapies. Founded in 2000, MEDIPOST focuses on utilizing mesenchymal stem cells (MSCs) derived from umbilical cord blood for therapeutic applications. The company's flagship product, CARTISTEM, is an allogeneic MSC-based therapy used for the treatment of osteoarthritis. MEDIPOST is committed to advancing the field of regenerative medicine through cutting-edge research, strategic partnerships, and a dedication to improving patient outcomes. With a strong emphasis on quality, safety, and efficacy, MEDIPOST continues to be at the forefront of cell therapy innovation globally.

Osiris (Mesoblast)

Osiris Therapeutics, now part of Mesoblast, is a pioneering biotechnology company focused on developing innovative cell-based therapies. Specializing in regenerative medicine, Osiris/Mesoblast has made significant strides in leveraging mesenchymal stem cells (MSCs) for treating a variety of medical conditions, including orthopedic disorders, inflammatory diseases, and cardiovascular conditions. Their flagship product, TEMCELL, is approved for graft-versus-host disease (GVHD) in Japan. The company's research pipeline continues to explore the therapeutic potential of MSCs across diverse therapeutic areas, positioning Osiris/Mesoblast as a key player in the field of cell therapy and regenerative medicine.

Other key players in the market include Stemedica Cell Technologies Inc., ImmunoACT, Castle Creek Biosciences, Inc., PHARMICELL Co. Ltd, ANTEROGEN.CO.LTD, Novartis AG, Celgene Corp. (Bristol-Myers Squibb Company), Allogene Therapeutics Inc., and Stempeutics Research Pvt. Ltd.

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Cell Therapy Market Size, Share, Growth, Report and Forecast 2024-2032 - openPR