Autologous Stem Cells for the Treatment of No Option Critical Limb Ischemia
Status:
Completed
Trial end date:
2019-10-31
Target enrollment:
Participant gender:
Summary
The trial is a phase 1b, open label, uncontrolled, non-randomized dose-escalation study of
autologous bone marrow-derived MSCs. Following informed consent, patients who meet the
criteria will be screened and enrolled. Up to 100 mls of bone marrow will be harvested from
the participant from which MSCs will be culture expanded. In this dose escalation study, 3
participants on each cohort will be treated with a targeted dose of either 20 million hMSC;
40 million hMSC; or 80 million hMSC. The cells will be administered to the ischemic leg by 20
intramuscular injections of approximately 0.5ml per injection . Treatment groups will be
completed sequentially, beginning with the lowest dose group.