US EditionXellSmart Gains FDA Clearance for Three iPSC Cell Therapies
- XellSmart Biomedical, based in Suzhou and Shanghai, China, develops off-the-shelf iPSC-derived cell therapies targeting CNS diseases with unmet medical needs as of June 2025.
- The company received seven IND approvals from both China’s NMPA and the U.S. FDA for clinical trials targeting Parkinson's disease, spinal cord injury, and ALS, all serious neurological disorders.
- XellSmart completed the first in-China case transplanting dopaminergic neural progenitor cells into moderate-to-advanced Parkinson's patients with no adverse events and follow-ups beyond 12 months.
- Data showed significant improvements in patients’ motor and non-motor symptoms, and the company launched multiple Phase I/II trials in China and the U.S. For Parkinson's, SCI, and ALS therapies.
- With dedicated international teams, proprietary technologies, GMP facilities, and strong venture capital backing, XellSmart advances clinical-grade iPSC therapies addressing intractable CNS disorders lacking effective treatments.
59 Articles
59 Articles
Rutland Herald
XellSmart Secures FDA Clearance for Three Phase I INDs of Allogeneic iPSC-Derived Cell Therapies Targeting Major CNS Diseases: Parkinson's Diseases, Spinal Cord Injury and ALS
SUZHOU, China, June 2, 2025 /PRNewswire/ -- XellSmart Biomedical Co., Ltd. (Suzhou/Shanghai, China) is a leading biotechnology company dedicated to the development of innovative iPSC-derived cell therapies. To date, the company has received seven Investigational New Drug (IND) approvals for…
XellSmart gains FDA clearance for three iPSC cell therapies
SUZHOU, China, June 3, 2025 /PRNewswire/ -- XellSmart Biomedical Co., Ltd. (Suzhou/Shanghai, China) is a leading biotechnology company dedicated to the development of innovative iPSC-derived cell therapies. To date, the company has received seven Investigational New Drug (IND) approvals for registered clinical trials from both the National Medical Products Administration (NMPA) of China and the U.S. Food and Drug Administration (FDA). All approv…
Coverage Details
Bias Distribution
- 62% of the sources are Center
To view factuality data please Upgrade to Premium
Ownership
To view ownership data please Upgrade to Vantage
