Asthma Clinical Trial
Official title:
A Phase I, Trial to Evaluate the Safety, Tolerability, and Potential Efficacy of Allogeneic Human Mesenchymal Stem Cell Infusion in Patients With Mild Asthma
A Phase 1 investigation will be performed to test the safety of two doses of bone marrow-derived MSCs (20,000,000 and 100,000,000) administered via peripheral intravenous infusion.
A Phase 1 investigation will be performed to test the safety of two doses of bone
marrow-derived MSCs (20,000,000 and 100,000,000) administered via peripheralintravenous
infusion.
Group 1: 3 subjects will receive a single administration of allogeneic hMSCs: 20 million
cells delivered via peripheral intravenous infusion Group 2: 3 subjects will receive a single
administration of allogeneic hMSCs: 100 million cells delivered via peripheral intravenous
infusion Interim safety analysis will be performed four weeks after the 1st subject is
enrolled in each cohort. Continued safety and tolerability with review of adverse events
(AEs) will be assessed at each visit. Efficacy parameters (pulmonary function tests,
diffusing capacity (DLCO), lung volumes, 6-minute walk test (6MWT), and dyspnea/quality of
life [QOL] questionnaires) will be assessed every 12 weeks until study completion. Clinical
laboratory tests to assess safety will be performed at every visit.
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