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 iPSCs, which are then differentiated into MSCs. This offers several advantages over traditional MSC therapies, which are often derived from limited, patient-specific sources. iMSCs provide a potentially infinite and more consistent cell source, bypassing issues related to donor variability, immune rejection, and the challenges of obtaining autologous cells. iMSCs also have the potential to be produced at low cost. 

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.

Cell & Gene Therapy Developers Need an Excipient-Certified Cell Culture Media Manufacturer

In cell and gene therapy, product safety and consistency are non-negotiable. Every component in the manufacturing process—including cell culture media—directly impacts product quality, patient safety, and regulatory success. That’s why using an excipient-certified cell culture media manufacturer is critical. Explore why Nucleus Biologics, the first excipient-certified custom media provider, is a trusted partner for excipient-grade solutions. 

Excipient certification confirms that the manufacturer adheres to stringent quality standards for raw materials, documentation, and process controls. This rigorous certification reduces risks from contaminants or batch variability, ensuring consistent performance in sensitive applications. It also provides full traceability and aligns with advanced regulatory expectations, streamlining compliance for critical development stages.

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 induced pluripotent stem cell (iPSC) line, hiEX™ Research iPSC Exosomes offer a consistent and scalable alternative to donor-derived exosomes.

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.

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 (Good Manufacturing Practices).

L2 Bio Seeks Principal Investigators for FDA-Approved Phase 2B Clinical Trial of Adipose-Derived Stem Cell Treatment for Crohn’s Disease 

HENDERSON, NV, June 12, 2025 – L2 Bio, is the clear leader in adipose-derived stem cell banking. L2 Bio is the only AD-Stem Cell Banking company with an FDA Approved Investigational New Drug. L2 is actively recruiting qualified Principal Investigators for its recently FDA-approved Phase 2B clinical trial. This groundbreaking study will investigate a novel intravenous (IV) delivery of adipose-derived stem cells (ADSCs or ASCs) for the treatment of Crohn’s Disease utilizing autologous or first-degree blood relative sourced Adipose Derived Mesenchymal Stem Cells (AD-MSCs). 

CHU Toulouse and Cell-Easy Receive Regulatory Approval of A3D: A Phase 1 Trial Using CellReady® in Alzheimer’s Disease

Toulouse, June 1, 2025 - Cell-Easy, a CDMO specialized in advanced cell therapies, announces that its allogeneic adipose-derived mesenchymal stem cell product, CellReady®, will be investigated in a newly approved Phase 1 clinical trial for Alzheimer’s disease. The A3D trial has received authorization from the European Medicines Agency (EMA). A3D is sponsored and promoted by CHU Toulouse, in collaboration with the Clinical Investigation Center in Biotherapy (CIC-BT), and coordinated by Dr Julien Delrieu, Principal Investigator of the study.

Applied StemCell Launches Two New Hypoimmunogenic hiPSC Products to Accelerate Allogeneic Cell Therapy Development

May 20, 2025, MILPITAS, Calif. — Applied StemCell, a CRO/CDMO that blends unique genome editing technology and iPSC expertise, launched their first hypoimmunogenic hiPSC products which are designed to empower researchers developing next-generation allogeneic cell therapies. The ActiCells™ RUO Hypo hiPSCs (Cat.# ASE-9550) and the ActiCells™ RUO TARGATT™ Hypo hiPSC Knock-in Kit (Cat.# AST-9650) offer powerful tools for building off-the-shelf therapies by combining reduced immunogenicity, robust pluripotency, and genome engineering readiness. 

Winner of the “Biotherapies and Bioproduction” Call for Projects Under the France 2030 plan, EVerZom Receives €3M in Government Funding to Industrialize its Exosome Bioproduction Technology

Paris, June 17, 2025 – EVerZom, a French biopharmaceutical company pioneering exosome-based therapies for regenerative medicine applications, has announced it has received €3 million in funding as part of the France 2030 plan, through the “Biotherapies and Bioproduction of Innovative Therapies” call for projects, operated by Bpifrance on behalf of the French government. This financial support will enable the company to accelerate the industrialization of its exosome bioproduction platform to develop its proprietary and co-developed drug candidates.

UniXell does first patient with an autologous iPSC-based cell therapy (UX-DA001) for Parkinson’s disease in Phase 1 study

Shanghai, May 23, 2025 — Shanghai UniXell Biotechnology Co., Ltd. (UniXell Biotech), a biotech company dedicated to innovative cell therapies, announced the successful first administration of its proprietary Parkinson’s disease cell drug UX-DA001 in China in March 2025. The Phase I clinical trial aims to evaluate the safety, tolerability, and preliminary efficacy of UX-DA001 in patients with Parkinson’s disease.

How CellPort Is Making Cell Culture Smarter – Interview with Patrick Dentinger, CEO of CellPort Software

In the dynamic world of cell therapy, where precision and reproducibility are paramount, one scientist’s frustration with cell unpredictability sparked an industry-changing innovation. After years at the bench wrestling with the inherent variability of cell culture, Patrick Dentinger recognized a deeper problem—labs weren’t equipped with the right tools to track, understand, and manage cellular drift.

MSC-Derived Therapeutics and Exosomes as Rising Stars in Advanced Therapeutics

The term MSC refers to a class of cells that have historically been known by various names, including mesenchymal stem cells, mesenchymal stromal cells, and medicinal signaling cells. The clinical relevance of MSCs is largely due to several important biological properties. These cells have the potential to migrate to sites of inflammation resulting from tissue injury when administered intravenously. They are also capable of releasing a variety of bioactive molecules that support the recovery of damaged cells. In addition, MSCs can help suppress inflammation, contribute to anti-fibrotic effects, and play a role in regulating immune responses.

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.

A Multi-Version Medicinal Technology System, Part II

In Part I of this article, we explored “MSC 2.0,” which is the second generation of mesenchymal stem/stromal cell (MSC) cellular technology. Like T cells, MSCs are a raw primary cellular source that irrigates multiple branches of downstream clinical applications that intermingle with other technologies. Although one potentially promising use of “v2.0” involves cell-cultured and/or cruelty-free meat (aka “clean meat”), we identify here that MSC 2.0 now supports other—more near-term—ventures of direct benefit to human health.

MSCs as an Appealing Raw Material for Use in Regenerative Medicine

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. iPSCs exhibit greater pluripotency, but as modified cells, they come with a greater set of regulatory challenges.

Venture Capital Funding Flowing into the iPSC Sector by Year 

The induced pluripotent stem cell (iPSC) sector has attracted strong venture capital funding in recent years, reflecting growing confidence in its potential across regenerative medicine, drug development, toxicology testing, personalized medicine, and disease modeling. From 2021 to 2024, numerous companies secured substantial investments, signaling a promising future for iPSC-based innovations. 2021 was a particularly strong year, with iPSC industry investments totaling over $2.15 billion.

[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] 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.

[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 your company, product candidate, or clinical trial, this database is a must-have. For 48 hours, 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? 

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