NatureCell, FDA Puts on Hold Review of Phase 1/2a Clinical Trial Plan for COVID-19 Stem Cell Therapy
[Asia Economy Reporter Minji Lee] Nature Cell announced on the 18th that the US FDA has put on hold the Phase 1/2a clinical trial plan review for AstroStem-V, an allogeneic adipose-derived mesenchymal stem cell therapy for COVID-19 pneumonia patients.
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The company stated, "The clinical trial plan review was put on hold due to insufficient data on characterization analysis and manufacturing and quality control," and added, "We will confirm the specific reasons for this decision and work to obtain approval for the clinical trial plan."
This content was produced with the assistance of AI translation services.
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