Toulouse, January 22, 2026 — Cell-Easy, a CDMO specialized in the development and GMP manufacturing of Advanced Therapy Medicinal Products (ATMPs), announces a new clinical milestone achieved in close collaboration with Toulouse University Hospital (CHU Toulouse). The European Medicines Agency (EMA) has granted Clinical Trial Authorization (CTA) for AMUSE, a Phase 1/2 clinical trial evaluating the safety and efficacy of an allogeneic mesenchymal stromal cell (MSC) therapy in patients with systemic sclerosis presenting perioral fibrosis and functional impairment. [Read more…]
A Spark Becomes a Surge: How Ryoncil Reignited MSC Development
It’s official: Today marks exactly one year since the cell therapy field celebrated a historic milestone. On December 18, 2024, the FDA granted its first-ever approval for a Mesenchymal Stem Cell (MSC) therapy, Mesoblast’s Ryoncil® (remestemcel‑L‑rknd).
This landmark decision marks not just a regulatory first, but a validation of decades of research into the therapeutic potential of MSCs. Once considered experimental, MSC therapies are now stepping into mainstream medicine, signaling the beginning of a new era in regenerative treatments. The approval has ignited renewed investment, scientific exploration, and clinical interest, setting the stage for rapid growth and broader adoption of MSC-based therapeutic products across multiple disease areas. [Read more…]
Patient Enrolment Complete in Phase 2 aGvHD Clinical Trial
Announcement Highlights:
- Patient enrolment has been completed in Cynata’s Phase 2 clinical trial of CYP-001 in acute graft versus host disease.
- The study has enrolled a total of 65 participants in the US, Europe and Australia, each of whom was randomised to receive either steroids plus CYP-001, or steroids plus placebo.
- Primary evaluation period expected to complete in March 2026, with results in June 2026.
- CYP-001 has potential to address a major unmet need for the treatment of aGvHD, a life-threatening condition.
Takara Bio Europe launches Cellartis® MSC EV Wonder™, a defined, xeno-free medium for high-yield EV production
September 24, 2025 – Takara Bio Europe announces the launch of Cellartis® MSC EV Wonder™, a defined, xeno-free medium engineered for the scalable production of extracellular vesicles (EVs) from human mesenchymal stem cells (MSCs).
MSC-derived EVs are increasingly recognized as next-generation, cell-free therapeutic candidates, offering regenerative and immunomodulatory benefits without the safety concerns associated with administering intact MSCs. As the field shifts from MSC-based approaches to MSC-EVs, researchers are seeking solutions that deliver both robust yields and reproducible quality at scale. [Read more…]
MSC Therapies: Globally Approved Mesenchymal Stem Cell Therapeutics
As the most common stem cell type being used within regenerative medicine, there is huge potential for growth within the mesenchymal stem cell (MSC) market. Today, MSCs are the most common stem cell type being used within clinical trials, as well as the most studied stem cell type within the scientific literature. [Read more…]
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