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Phase I/II randomized open-label study of autologous stem cell therapies for critical lower-limb ischemia in insulin-treated type 2 diabetes
2010-019774-33Phase 2Terminated
- Sponsor
- Andalusian Progress and Health Public Foundation
- Start
- Jan 2012
- Modality
- Stem Cell Therapies → Cell Therapies
- Countries
- 1
01
Overview
Phase 2, randomised, open-label trial of autologous adipose-derived mesenchymal stromal cells, autologous bone marrow-derived mononuclear cell and autologous CD133+ bone marrow endothelial progenitor cells in chronic limb-threatening ischemia (CLTI), arteriosclerosis obliterans and type 2 diabetes mellitus (T2DM) (4 arms), sponsored by Andalusian Progress and Health Public Foundation. Primary endpoints: Insulin therapy requirement, C-peptide and 8 more. Started Jan 2012; status: terminated.
02
Drugs
autologous adipose-derived mesenchymal stromal cellsautologous bone marrow-derived mononuclear cellautologous CD133+ bone marrow endothelial progenitor cells
03
Conditions
chronic limb-threatening ischemia (CLTI)arteriosclerosis obliteranstype 2 diabetes mellitus (T2DM)
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