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A Phase I Study to Evaluate Two Doses of Wharton's Jelly-Derived Mesenchymal Stromal Cells for the Treatment of De Novo High-Risk or Steroid-Refractory Acute Graft Versus Host Disease.

Rupal P SoderBuddhadeb DawnMark L WeissNeil DunavinScott WeirJames MitchellMeizhang LiLeyla ShuneAnurag K SinghSiddhartha GangulyMarc MorrisonHaitham AbdelhakimAndrew K GodwinSunil AbhyankarJoseph P McGuirk
Published in: Stem cell reviews and reports (2021)
Treatment of patients with de novo HR or SR aGVHD with low or high dose MSCTC-0010 was safe: the infusion was well-tolerated, and no TRAEs or ectopic tissue formation was observed. A clinical improvement was seen in about 70% patients, with 4 of 10 showing a complete response that may have been attributable to MSCTC-0010 infusions. These observations indicate safety of two different doses of MSCTC-0010, and suggest that the 10 × 106 cells/ kg dose be tested in an expanded randomized, controlled Phase 2 trial. Graphical abstract.
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