Publicly Announced RMAT Designations Climb to 139 as Momentum Builds

To date, biotech and pharma companies have publicly announced 139 FDA-approved RMAT (Regenerative Medicine Advanced Therapy) designations. The FDA reports receiving 368 requests and issuing 184 designations, indicating that some remain undisclosed—suggesting a number of companies are operating in stealth mode. The approval rate stands at 50% (184 / 368 = 50%). Rocket Pharmaceuticals leads with five RMATs, followed by CRISPR Therapeutics with four. Allogene, AlloVir, Humacyte, and Mesoblast each hold three, while 13 other companies have received two RMAT designations.

Generate Billions of Xeno-Free Fibroblasts for Your R&D Program

Designed with scalable manufacturing in mind, RoosterVial™-hDF working cell banks contain >1 million cryopreserved xeno-free primary human dermal fibroblasts (hDFs) isolated from normal neonatal foreskin for translational research and product development. When paired with RoosterNourish™ expansion media, leverage a manufacturing process that includes no media exchanges to efficiently generate billions of cells.

REPROCELL’s StemRNA™ iPSC Seed Stock Clones for Seamless Translational Research

The translation of stem cell therapies begins with a well-characterized and thoroughly documented starting cell source. REPROCELL’s StemRNA™ Clinical iPSC Seed Stock Clones offer cell therapy developers streamlined starting material that provides a gateway into early-stage clinical development. By combining regulatory alignment with ethical sourcing and footprint-free mRNA reprogramming, REPROCELL now offers various male and female, ready-to-use, clinical-grade iPSC lines manufactured in our facilities, in the U.S. and Japan.

Save up to $300 with Early-Bird Registration! Show Up For Science at the 2025 AABB Annual Meeting, Oct 25-29 in San Diego

Join the Association for the Advancement of Blood & Biotherapies (AABB) at the 2025 AABB Annual Meeting - the premier event for the blood and biotherapies field. This can’t-miss event is so more than just a meeting; it’s a chance for you to stand at the forefront of science, expand your knowledge, grow your network and bring new momentum to your work as a biotherapies professional.

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Vita Therapeutics and I Peace to generate iPS- derived differentiated cells for transplant therapy with an initial focus on FSHD using universal iPS cells

Palo Alto, CA, July 10, 2025 – Leading GMP cell CDMO I Peace, Inc., specializing in iPSCs and iPSC-derived cell therapies, announced that it has agreed with Vita Therapeutics to jointly develop universal iPS cells that will be used for cell transplantation therapy. GMP-grade iPS cells will be modified with proprietary, licensed gene editing technology to make a base platform hypoimmune line where Class I and II HLA genes that determine rejection have been depleted. These hypoimmune lines can be further customized in I Peace cGMP facilities.

Future Medical Products LLC Announces the Launch of PBME Topical™ (Pure Bone Marrow Exosomes)

July 24, 2025, St. Louis, Missouri — Future Medical Products LLC has launched PBME Topical (“Pure Bone Marrow Exosomes”), a cosmetic product developed in compliance with the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). PBME Topical consists of isolated exosomes from MSCs, the most studied cell in science. These exosomes feature phospholipid bilayers with embedded transmembrane proteins and receptors, integrated growth factors, as well as micro-RNA and messenger RNA. The source of the exosomes intended for aesthetics, as well as regenerative medicine, is critical. Bone marrow exosomes are considered by some to be the purest form of stem cell therapy without the cell.

Ciloa Secures €6.5 Million Government Funding from France 2030 ‘Innovation in Biotherapies and Biomanufacturing’ to Develop Drug Candidate for Treatment of Obesity and Type 2 Diabetes

Montpellier, France, July 7, 2025 – Ciloa, a pioneer in bioengineering extracellular vesicles to develop a new generation of therapeutics and preventive solutions to improve patients’ lives, announces it has secured €6.5 million ($7.6M) of funding via the France 2030 ‘Biotherapies and Biomanufacturing of Innovative Therapies’ call for proposals, organized by Bpifrance on behalf of the French government. The funding will enable clinical development of Ciloa’s candidate APN-sEV (Adiponectin associated with exosomes) up to phase IIa in type 2 diabetes and obesity, and the implementation of large-scale manufacturing under GMP conditions .

Japan Moves Toward Permitting Fertilized Embryo Research Using iPSC-Derived Eggs and Sperm

A Japanese government bioethics panel approved the creation of human embryos using sperm and eggs derived from pluripotent stem cells, including iPSCs, for research purposes. This research aims to advance understanding of infertility and genetic diseases but strictly prohibits any reproductive use. The panel set limits, only permitting embryos to be cultured for a maximum of 14 days and banning any implantation into human or animal wombs. Understandably, this decision raises serious ethical concerns, including the potential future use of such embryos in reproduction.

uBriGene Launches Clinical iPSC Banks to Accelerate Regenerative Medicine and Cell Therapy Development 

ROCKVILLE, MD, June 16, 2025 – uBriGene Biosciences, a leading cell and gene therapy CDMO, is proud to announce the launch of its fully characterized, ready-to-use induced pluripotent stem cell (iPSC) banks. Developed using uBriGene’s proprietary RNA-LNP reprogramming technology, these iPSC banks are now available to support research, translational development, and clinical applications worldwide.

Longeveron® Announces Licensing of New Cardiac Selective iPSC Technology for Cardiovascular Disease

MIAMI, FL, July 21, 2025 —  Longeveron (NASDAQ: LGVN) announced it has licensed an issued US patent (12,168,028 B2) for a stem cell technology from the University of Miami. The composition of matter patent protects unique induced pluripotent derived cardiomyogenic cells that have widespread therapeutic indications for heart diseases. The stem/precursor cells protected by this patent are obtained by deriving cells that bear a cell surface receptor known as the GHRH-Receptor. These cells are uniquely able to differentiate into human cardiac muscle cells and have the potential to be safer than existing strategies to derive new cardiac heart muscle cells.

First-in-Human Trial of OpCT-001: An iPSC-Derived Cell Therapy for Primary Photoreceptor Diseases

Berlin, Germany, and Cambridge, MA, USA July 8, 2025 – Bayer AG and BlueRock Therapeutics LP, a clinical-stage cell therapy company and subsidiary of Bayer AG, announced that the first patient received the investigational therapy in CLARICO, a Phase 1/2a clinical trial of OpCT-001, an investigational iPSC-derived cell therapy for the treatment of primary photoreceptor diseases. OpCT-001 is the first iPSC-derived investigational cell therapy to be clinically tested for treating primary photoreceptor  diseases.

STEMCELL Technologies Launches STEMprep™ System to Streamline Tissue Dissociation in Research

VANCOUVER, British Columbia, June 27, 2025 - STEMCELL Technologies has launched the STEMprep™ Tissue Dissociator System, a benchtop device that automates and standardizes tissue dissociation to produce consistent, high-yield single-cell suspensions. Designed to save time and improve data quality, STEMprep™ supports a range of solid tissues while preserving cell integrity. Researchers can run ready-to-use protocols or customize workflows for specific experimental needs.

Cellino’s iPSC Manufacturing Technology Receives FDA Advanced Manufacturing Technology (AMT) Designation

CAMBRIDGE, Mass., July 1, 2025 — Cellino, a leader in advanced biomanufacturing, announced that its optical biomanufacturing technology for generating iPSCs has received the FDA’s Advanced Manufacturing Technology (AMT) designation from the Center for Biologics Evaluation and Research (CBER). This prestigious designation highlights the transformative potential of Cellino’s automated technology for scaling up high-quality iPSCs to industrialize next-generation regenerative therapies.

Applied StemCell Launches hiEX™ Research iPSC Exosomes to Power Next-Generation Regenerative Medicine Research

MILPITAS, Calif., June 24, 2025 — Applied StemCell, a leading provider of advanced stem cell and gene editing technologies since 2008, announced the release of hiEX™ Research iPSC Exosomes, a new research-use-only product designed to enable scientists to explore the therapeutic potential of iPSC-derived exosomes in areas such as wound healing, aging, and nerve regeneration. Isolated from a single, well-characterized iPSC line, hiEX™ Research iPSC Exosomes offer a consistent and scalable alternative to donor-derived exosomes. 

Exosomes: Company Spotlights from “A” to “Z”

Exosomes are small vesicles found in nearly all eukaryotic fluids that facilitate a range of important cellular functions. They transfer DNA, RNA, and proteins to other cells, thereby altering the function of the targeted cells. In recent years, exosomes have gained attention as a strategy for accessing the therapeutic effects of cells without the risks and difficulties of administering whole cells to patients. With at least 38,828 scientific articles published about exosomes and 477 clinical trials submitted, these small vesicles have intriguing potential to be used across a wide range of therapeutic applications.

Induced Pluripotent Stem Cell (iPSC) Industry Trends Dominating in 2025

Today in 2025, iPSC are being used across a wide range of applications in both basic and applied science. These include cellular therapy, disease modeling, drug development, toxicology testing, personalized medicine, and tissue engineering. iPSCs are also foundational in newer fields like organoid production, 3D bioprinting, cultured meat, and wildlife conservation. Derived from reprogrammed somatic cells like skin or blood, iPSCs can differentiate into nearly any cell type, making them valuable for studying disease progression, testing therapies, and advancing regenerative medicine. 

Venture Capital Funding Flowing into the iPSC Sector by Year

The iPSC sector has seen strong venture capital interest in recent years, with total investments reaching $3.42 billion between 2021 and 2024. Remarkably, $2.15 billion (62.9%) was raised in 2021 alone, marking a peak in funding activity. This surge reflects growing investor confidence in iPSC technologies. Companies at all stages, from early startups to IPO-ready firms, have attracted substantial backing. This article highlights major funding events, tracks trends over time, and profiles the key players driving the industry’s momentum during this transformative period for stem cell-based innovation.

The Future of Allogeneic Cell Therapy is Off-the-Shelf and iPSC-Based – An Interview with Cellistic’s Founder and CTO, Stefan Braam, PhD 

In the rapidly evolving field of cell therapy, scalability and accessibility remain two of the biggest challenges for widespread patient impact. Cellistic, a leading company that is pioneering allogeneic cell therapy solutions, is tackling these obstacles head-on with its novel iPSC technologies. In this interview, Stefan Braam, PhD, Founder & CTO of Cellistic, shares insights into the company’s journey, its innovative platforms—including Pulse™, Echo™, and the newly introduced Allo Chassis™—and how these advancements are poised to redefine cell therapy development as we known it.

MSCs as “Therapeutic Workhouses” in the Era of Regenerative Medicine 

MSCs are a class of multipotent cells found in human tissues, such as bone marrow, adipose tissue, dental pulp, and periosteum. MSCs are of intense therapeutic interest because they represent a population of cells that have the potential to treat a wide range of acute and degenerative diseases. First, they avoid the ethical issues that surround embryonic stem cell research. Second, studies have found MSCs to be immuno-evasive, which make them an advantageous cell type for allogenic transplantation. MSCs reduce both the risks of rejection and complications of transplantation. 

The Pipeline for iPSC-Derived Cell Therapeutics in 2025 

Today, at least 74 cell therapy companies worldwide are developing iPSC-derived therapeutics for human use, an astounding level of growth for a cell type discovered less than 20 years ago. In addition, a growing number of research institutes, government agencies, and academic centers are contributing to the field. This article highlights the pioneering companies and organizations leading the way in advancing iPSC-derived cell therapies.

[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 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 a company, product candidate, or clinical trial, this database is a must-have. For 48 hours only, you can claim it for an unusual 50% off.

[SALE] Mesenchymal Stem Cells / Medicinal Signaling Cells (MSCs) – Advances & Applications, 2025

Today, 12 MSC-based products have received regulatory approvals. This includes 11 full approvals and a 12th conditional approval within China. The Republic of Korea has approved five products; Japan and the EU have approved two products; and India, Iran, and Australia have approved one each. Market competitors have also developed 17 biomaterial-based MSCs and MSC progenitor products, which are largely being used for orthopedic indications. Companies like Cynata are pioneering iPSC-derived MSC (iMSC) production technologies, supporting large-scale therapeutic development. In total, at least eight companies are now developing iMSCs.

[REPORT] Global Induced Pluripotent Stem Cell (iPSC) Industry Report – Market Size, Trends, & Forecasts, 2025

In addition to companies developing iPSC-derived cellular therapeutics, a growing number of competitors are commercializing iPSC products for diverse applications—ranging from drug discovery and disease modeling to toxicology testing, personalized medicine, tissue engineering, 3D bioprinting, and clean meat production. This report presents key industry metrics, including scientific publications, clinical trials, patents, funding rounds, strategic partnerships, and M&A activity. It identifies major global iPSC market players and provides detailed market size data segmented by Application, Technology, Cell Type, and Geography (North America, Europe, Asia-Pacific, and RoW), along with projections through 2030.

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? 

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