China’s NMPA Approves Country’s First MSC-Based Cell Therapy, Ruibosheng

On January 2, 2025, China’s National Medical Products Administration (NMPA) granted conditional approval to Platinum Life Excellence Biotech Co. Ltd.’s amimestrocel injection (hUC-MSC PLEB-001), marking a significant milestone in the country’s medical and biotechnological advancements. The product is being marketing under the brand name Ruibosheng. This approval designates it as China’s first human umbilical cord-derived mesenchymal stem cell (hUC-MSC) therapy, offering a promising treatment option for steroid-refractory acute GVHD, an often fatal complication following stem cell transplants.

GMP Working Cell Banks to Accelerate MSC & Exosome Therapies into the Clinic

Save critical time and valuable resources while ensuring your path to clinical implementation by utilizing a consistent supply of high-volume, well-characterized working cell banks. Available from multiple tissues and donors, RoosterBio’s Xeno-Free CliniControl™ MSCs are manufactured in compliance with current Good Manufacturing Practices, supported by US FDA Type II Master Files, and designed to help you bypass the major costs and risks of GMP cell bank manufacturing.

Nucleus Biologics Becomes First Custom Cell Culture Media Company to Achieve EXCiPACT Certification for the Manufacture of Excipient GMP Quality Cell Culture Media, Supplements, and Buffers

San Diego, CA, Jan. 9, 2025 – Nucleus Biologics, a leader in precision cell culture media development, has achieved an industry-leading quality milestone. It has received EXCiPACT certification for Pharmaceutical Excipients and Pharmaceutical Auxiliary Materials (PAMs) and ISO 9001 certification from SGS. This Excipient GMP certification will better support the cell culture media, buffers, reagents, and supplements needs for its cell and gene therapy customers. This certification, in addition to its ISO 13485 certification, underscores Nucleus Biologics’ commitment to delivering the highest quality products that meet the most stringent safety, consistency, and compliance requirements of the biopharmaceutical industry.

Ncardia Launches Ncyte® Microglia 

LEIDEN, THE NETHERLANDS, Feb. 4, 2025 - Ncardia, a leader in human iPSC technology, has launched Ncyte^® Microglia, a groundbreaking tool to advance research in neurodegenerative diseases and CNS disorders. Ncyte^® Microglia are hiPSC-derived models that closely mimic primary human microglia, exhibiting key functional characteristics such as phagocytosis, cytokine signaling response, and the expression of microglial markers including IBA1, TREM2, and TMEM119. These features make Ncyte^® Microglia highly suitable for studying microglial behavior in disease-relevant contexts, assessing immune responses, and enabling high-throughput drug screening applications.

I Peace manufactures 100 lines of GMP iPS Cells cumulatively 

Palo Alto, CA, Jan. 7, 2025 — Leading GMP cell CDMO I Peace, Inc., specializing in induced pluripotent stem cells (iPSCs) and iPSC-derived cell therapies, announced that the number of GMP-grade iPS cells manufactured has reached 100 lines. This achievement solidifies I Peace as a true leader in the realm of  iPS cell manufacturers, equipped with abundant experience in manufacturing GMP-grade iPS cells in compliance with global regulations.

Cost-Effective & Ultra-Scalable FGF-2 TOP® to Unlock the Potential of iPSC Research

Reduce cost, save time, and simplify scale-up while optimizing your stem cell culture conditions with FGF-2 TOP® GMP, a high-performing, thermostabilized, plant-based recombinant protein. Nucleus Biologics FGF-2 TOP® GMP protein is derived from a proprietary, plant-based production process that ensures high purity and sustainability, while its unique bioproduction process delivers significant cost savings.

Additionally, by eliminating the need for repeated supplementation and daily medium changes, expenses can be further reduced and convenience enhanced, streamlining workflows for greater efficiency. With its ultra-scalable manufacturing method and ability for proteins to be stored as seeds, supply chain bottlenecks are eliminated, ensuring a reliable source of GMP-grade proteins. Explore FGF-2 TOP® GMP today!

CHU Toulouse receives CTA Approval to initiate ALLOFIST, a Phase 1/2 Trial based on Cell-Easy’s proprietary adipose-derived MSC in Patients suffering from Crohn Disease.

Toulouse, France, Jan. 16, 2025 – The partnership between Cell-Easy and Toulouse University Hospital continues to bear fruits, bringing innovative MSC-based therapies to local patient cohorts. This time, it’s in the field of Crohn’s disease that the pair is experimenting with the allogeneic cell therapy approach. By tackling all CMC, regulatory and medico-economic concerns, the Cell-Easy CDMO has succeeded in developing a cell therapy drug from scratch in just 2 years. The principal investigator, Dr. Buscail, submitted a request for authorization of CTA to the EMA, which was rapidly accepted. An initial cohort of patients suffering from Crohn’s disease will be able to benefit from this experimental innovant treatment starting in 2025 Q1.

Axol Bioscience Secures SMART Grant to Accelerate the Development of a Commercial iPSC-Powered ALS Models

Cambridge, UK, Dec. 28, 2024 - Axol Bioscience has been awarded a SMART Grant by Scottish Enterprise to Accelerate ALS Research through the development of ALS-related phenotypes using human iPSCs. This represents another significant step towards better disease modelling and ALS drug discovery. The award comes at a pivotal time as the scientific community intensifies its focus on developing better human- relevant in vitro models, for neurodegenerative diseases, such as Amyotrophic Lateral Sclerosis (ALS).

Innovative Functional Peptides Successfully Co-Developed as Alternatives to Growth Factors Used in the Manufacturing of Regenerative Medicine Products

Tokyo, Japan, Jan. 29, 2025 - Orizuru Therapeutics (OZTx), a Japanese biotech  focusing on iPSC-derived regenerative medicine, and PeptiGrowth, a Japanese biotech specializing in synthetic peptide based growth factors, announced the successful completion of the joint development project for a chemically synthesized peptide as an alternative to specific recombinant growth factors used in the manufacturing of regenerative medicine products developed by OZTx. The developed peptide was confirmed to bind to cellular receptors in a manner similar to the respective recombinant growth factor, inducing phosphorylation and signaling within the cells, thereby triggering differentiation and proliferation of iPSCs.

Restoration of Whole-Person Health: Re-envisioning Global Access

January 8, 2025 - Scientists increasingly agree that the convergence of advanced longevity technologies and regenerative medicines offers great promise for chronic disease prevention and optimal health throughout the individual’s lifespan. Thought leaders in these fields lament that in the rapidly evolving medical landscape, the journey from groundbreaking research to practical application is often fraught with challenges. HEALinc, a future health research and development (R&D) organization founded by Dr. Desirée Cox, is dedicated to overcoming the “Valley of Death” hurdle and ensuring that life-changing, longevity-enhancing therapies reach those who need them most.

IPS HEART’s Secures Orphan Drug Designation for iPSC-Derived Mesenchymal Progenitor Cell (MPC) Therapy, GIVI-MPC

Houston, TX, Jan. 18, 2025 - In a groundbreaking development for the treatment of muscular dystrophies, IPS HEART received Orphan Drug Designation (ODD) from the U.S. FDA on January 13th, 2025, for its innovative stem cell therapy, GIVI-MPCs. GIVI-MPCs are mesenchymal progenitor cells derived from induced pluripotent stem cells (iPSCs) that have the potential to treat Becker Muscular Dystrophy (BMD). This milestone recognizes the therapy’s unprecedented ability to generate new skeletal muscle containing full-length dystrophin—a crucial protein missing or defective in individuals with BMD.

Eterna Therapeutics Releases Positive Preclinical Results for ERNA-101, an Allogenic iMSC Therapeutic

Cambridge, Mass., Jan. 14, 2025 — Eterna Therapeutics (Nasdaq: ERNA), a leader in cell therapies for the treatment of advanced solid tumors, announced positive results from a preclinical study on the company’s lead cell therapy product, ERNA-101, which is designed to activate and regulate the immune system’s response to recognize and attack ovarian cancer cells. This successful proof-of-concept study demonstrated massive T cell infiltration after only one dose of ERNA-101, reduced tumor burden, and extended survival in mice with ovarian cancer.

Tolerance Bio Announces Scientific Advisory Board and $20.2M Seed Round to Advance Thymus-Based Therapies for Immune-Mediated Diseases

Philadelphia, PA, Dec. 19, 2024 –Tolerance Bio, Inc., a biopharma company pioneering innovative approaches to increasing health span by preserving, restoring, and manipulating the function of the thymus, the master regulator of immune tolerance, announced the formation of its Scientific Advisory Board (SAB) and the completion of its oversubscribed $20.2M seed financing round.

Answer ALS Releases World’s Largest ALS Patient-Based iPSC and Bio Data Repository

New Orleans, LA, Dec. 23, 2025 – In a landmark continuing collaboration, Answer ALS and Cedars-Sinai have announced the completed availability of the largest amyotrophic lateral sclerosis (ALS) patient-based induced pluripotent stem cell (iPSC) and bio data repository. The repository encompasses biological and clinical data from nearly 1,000 ALS patients, offering an unprecedented resource for global researchers studying ALS, commonly known as Lou Gehrig’s disease.

The Remarkable Rise of iPSC-derived MSC Therapeutics: iMSCs

The rise of iPSC-derived mesenchymal stem cells (iMSCs) represents a significant evolution in regenerative medicine. iMSCs are generated by reprogramming adult somatic cells, typically fibroblasts, into induced pluripotent stem cells (iPSCs), which are then differentiated into mesenchymal stem cells (MSCs). This breakthrough technology offers several advantages over traditional MSC therapies, which are often derived from limited, patient-specific sources such as bone marrow or adipose tissue.

MSCs: A Multi-Version Medicinal Technology System (Part I)

The world’s first approved monoclonal antibody product, Muromonab-CD3 (Orthoclone OKT3), launched in 1986, exemplifies “mAb version 1.0,” preceding a wave of more manufacturable and better-engineered products in the late ’90s. Later molecular and process iterations took decades to evolve into platforms like CAR-T, BiTEs, diagnostics, and biosensors. Similarly, MSCs are following a path of convergent evolution. Here, we explore how these cells are shaping the future of advanced therapeutics, not just as standalone doses but as key components of engineered therapies for “MSC 2.0” and beyond.

MSCs as a Pivotal Tool for Cell Therapy, Gene Therapy, and Tissue Engineering

MSCs have many fascinating properties, including strong immunomodulatory effects, the ability to repair damaged tissues, and the capacity in vitro to differentiate into other cells types. These traits, combined with their easy availability from different sources, has prompted researchers to look at MSCs as promising raw materials for use in cell therapy, gene therapy, and tissue engineering, the three pillars of regenerative medicine. The efforts of scientists, researchers and life science companies have resulted in the approval of a dozen MSC-based cell therapies, 17 biomaterial-based MSC and MSC progenitor products, and 20 products that utilize MSC-derived conditioned or spent culture media.

Funding Flows Freely into Exosome Therapeutics in 2025

The therapeutic applications of exosomes, particularly those derived from stem cells and cancer cells, continue to expand in 2025, driving accelerated innovation in this dynamic market. Emerging trends highlight the potential of exosomes as both diagnostic tools and cell-free therapeutics, with increasing applications across diverse fields such as oncology, neurology, and regenerative medicine. In parallel, a growing number of life science companies are providing advanced tools and reagents to support exosome research, reflecting the sector’s rapid growth.

The Booming Market for Exosomes in 2025

Exosome-related technologies have been developing rapidly over the past few years and substantial growth is expected for the market as they get integrated into the fields of liquid biopsy, precision medicine and regenerative medicine. In particular, cancer derived exosomes influence the invasive potential of cells by regulating angiogenesis, metastasis, and immunity, making them an extremely useful source of biomarkers for use in cancer detection, diagnosis, and therapeutic selection.

How Human iPSCs are Revolutionizing Drug Discovery in 2025

Drug discovery involves high cost and uncertain outcomes. Only a few companies can take the risk of investing enormous amounts of money into research and testing, only to see undesirable side effects emerge during the final human trials. Thankfully, some new medicines are now being tested for safety on specialized cells developed from human pluripotent cell lines. Cell types which are increasingly being used within drug discovery applications include heart (cardiomyocytes) and liver cells (hepatocytes), which are the organs where 80% of drug failures occur.

MSCs as an Appealing Raw Material for Use in Regenerative Medicine 

Mesenchymal stem cells (MSCs) are a type of non-controversial, adult cell. When manipulated within a laboratory, then can be differentiated into the specialized cells found in skeletal tissues, such as cartilage cells (chondrocytes), bone cells (osteoblasts), and fat cells (adipocytes). In contrast, stem cells derived from embryos are capable of developing into all the different types of cells found in our body, which makes them more versatile than MSCs, but also more controversial. Induced pluripotent stem cells also exhibit greater pluripotency, but as modified cells, they come with a greater set of regulatory challenges.

List of U.S. FDA Approved Cell and Gene Therapy Products (43)

Today, researchers and clinicians are under great pressure to develop therapies capable of reversing or significantly impacting the progression of disease. This article presents all known cell and gene therapy products that have been licensed by the Office of Tissues and Advanced Therapies (OTAT), a division of the U.S. FDA. At present, 43 cell and gene therapies have been approved within the U.S. To date, no exosome therapies have received FDA approval, although the clinical trial pipeline looks promising.

The Pipeline for iPSC-Derived Cell Therapeutics in 2025 

Today, there are at least 72 cell therapy companies worldwide that are developing iPSC-derived cell therapeutics for use in human patients, which is astounding growth for a cell type that was discovered less than 20 years ago. There are also a growing number of research institutes, government agencies, and academic centers working in this field. This article reveals the pioneering companies and organizations that are forging the path toward iPSC-derived cellular therapeutics for use in human patients.

Top Companies Developing Cell Therapy Treatments For Diabetes in 2025

With diabetes rates rising and costs reaching $245 billion annually in the U.S., an accelerating number of companies are developing stem cell-based therapies to address the disease. A major milestone was achieved by the Diabetes Research Institute, where a clinical trial patient stopped insulin therapy after receiving implanted islet cells. Today, at least 21 companies are exploring stem cell-based solutions to diabetes. This article explores these pioneering companies, as well as their cutting-edge solutions to this debilitating disease.

Cord Blood Banking Consolidates in All Major Markets in 2025

Cord blood and tissue banking is the collection and preservation of the valuable cells within the umbilical cord of a newborn for future medical use. For both therapeutic and financial reasons, the cord blood industry has been witnessing record levels of M&A activity in recent years. Today, the vast majority of the global cord blood market is controlled by the world’s ten largest cord blood banking operators.

What Is An RMAT? List of Publicly Announced RMAT Designations (117)

To date, what number of U.S. FDA-approved RMATs have been issued and to whom have they been awarded? The answer is that 117 RMAT designations have been publicly announced by biotech and pharma companies. However, the FDA states it has received 279 requests and issued 128, which means that a handful are not yet public knowledge. The most recent addition to this list was Beacon Therapeutics' gene therapy laru-zova for the treatment of X-linked retinitis pigmentosa on January 28, 2025. 

[REPORT] Mesenchymal Stem Cells / Medicinal Signaling Cells (MSCs) - Advances & Applications

MSCs are essential raw materials for many regenerative medicine products, including cell-based therapies, engineered tissues, exosome products, and cultured meat production Today, a dozen MSC-based cell therapies are available globally. This includes 11 full approvals and a conditional approval within China. Only one is approved for use within the U.S., Mesoblast’s Ryoncil (remestemcel-L-rknd), which recently received FDA approval on December 18th, 2024. A 13th product, Takeda’s Alofisel, was previously approved by the EMA in 2018, but it was withdrawn in December 2024. Market competitors have also developed 17 biomaterial-based MSC and MSC progenitor products and the cosmetic industry has released 20 products that utilize MSC-derived conditioned or spent culture media. 

[REPORT] Global CAR-T Cell Therapy Market - Market Size, Forecasts, Trials & Trends, 2025

Since 2017, 13 CAR-T cell therapies have reached commercialization. Seven therapies have been approved by the U.S. FDA, after which approvals for them were issued in other healthcare markets as well. These therapies include Kymriah, Yescarta, Tecartus, Breyanzi, Abecma, Carvykti, and Aucatzyl.  Beyond the U.S., four CAR-T therapies—Relma-cel, Fucaso, Yuanruida, and Zever-cel—have been approved by China’s NMPA. Additionally, two therapies, NexCAR19 and Qartemi, have received approval from India’s CDSCO. This report reveals market size figures for the Global CAR-T Cell Therapy Market, segmented by Product, Geography, and Indication, with forecasts through 2032.

[SALE] Global Database of Regenerative Medicine Industry Investors, 2025

Regenerative medicine companies are those involved with cell therapies, gene therapies, exosomes, tissue engineering, biomaterials, or other therapies involving the use of human cells and tissues. Understandably, investor capital is often needed to support these therapeutics from preclinical development through clinical trials to commercialization. This database reveals the identity and investment behavior of over 300 investors who specialize in companies commercializing regenerative medicine (RM) and advanced therapy (AT) products. If you are in the process of raising investor capital for your company, product candidate, or clinical trial, then this database is a must-have. For 48 hours only, you can claim it for an unusual 50% off. 

Interested to learn about other market segments, such as MSCs, iPSCs, CAR-T cells, exosomes, cord blood and tissue, or the cell therapy industry at large? 

Explore the BioInformant Shop.

*Want to advertise in this newsletter? Contact us at Info@BioInformant.com.