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…]
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.
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, www.L2Bio.com – 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). A simple, virtually painless, 15-minute procedure from the subject or donor is likely to produce enough stem cells to treat the subject for the duration of the trial and likely the remainder of their life if necessary. [Read more…]
Pluristem Therapeutics, Interview with Yaky Yanay, President and Co-CEO
Pluristem Therapeutics (PSTI) is a clinical-stage company that is a proprietary 3D manufacturing technology to develop placental cell therapies for conditions that include ischemia, muscle injury, and exposure to radiation. I had the honor of interviewing Mr. Yaky Yanay, President and Co-CEO of Pluristem Therapeutics.
In this interview, we discuss the history of Pluristem Therapeutics, its clinical-stage products, intellectual property (IP) portfolio, marketing strategy and future directions.
Enjoy these insights into Pluristem Therapeutics, a world-class leader in cell therapy manufacturing and placental-derived products. [Read more…]
Cynata’s iPSC-derived Cell Therapeutic
(CYP-001) Meets Safety & Efficacy Endpoints
Cynata Therapeutics Ltd (ASX: CYP) is a clinical stage regenerative medicine company specializing in stem cell therapeutics that has a proprietary technology for manufacturing induced pluripotent stem cell (iPSC) derived mesenchymal stem cells (MSCs). Cynata is the only company in the world that can mass-produce therapeutic mesenchymal stem cells deriving from a single donor at a consistent quality and affordable cost. [Read more…]
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