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BM-MNC vs Allo-WJ-MSCs in Diabetic CLTI
NCT05631444Phase 2
Key facts
- Status
- Completed
- Start
- Jan 2019
- Primary completion
- Sep 2020
- Countries
- 1
- Sponsor
- FOSCAL
- Modality
- Stem Cell Therapies
- Drugs
- autologous bone marrow-derived mononuclear cellallogeneic Wharton's jelly-derived mesenchymal stem cells
- Conditions
- chronic limb-threatening ischemia (CLTI)
01
Overview
Phase 2, randomised trial of autologous bone marrow-derived mononuclear cell and allogeneic Wharton's jelly-derived mesenchymal stem cells in chronic limb-threatening ischemia (CLTI) (3 arms), sponsored by FOSCAL. Primary endpoints: Safety profile: adverse events (AEs) and serious AEs at 12 months, Efficacy profile: Rutherford's classification at 12 months and 7 more. Started Jan 2019; status: completed.
02
Design
3 arms- Study design
- Randomized
Placebo group
15 injections of 1 mL saline solution with 2% autologous serum
Auto-BM-MNC
15 injections of autologous BM-MNC (7.197x10^6 cells/mL)
Allo-WJ-MSCs
15 injections of allogeneic WJ-MSCs (1.333x10^6 cells/mL)
03
Who it enrols
Patients with type 2 diabetes and severe chronic limb-threatening ischemia (Rutherford 3-5, TcPO2 <= 30 mmHg) who are non-revascularizable or have failed revascularization.
04
Endpoints
Primary
Safety profile: adverse events (AEs) and serious AEs
Efficacy profile: Rutherford's classification
Transcutaneous oxygen pressure
Efficacy profile: Visual Analogue Scale pain
Efficacy profile: Pain-free walking distance
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