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Autologous Peripheral Blood Mononuclear Cells for Limb Salvage in Diabetic Foot Patients With No-option Critical Limb Ischemia
The objective of this trial is to determine whether PBMNCs in diabetic patients with critical, non revascularizable limb ischemia can prevent major amputation and affect mortality and healing.
Details
| Lead sponsor | Ospedale San Donato |
|---|---|
| Phase | NA |
| Status | COMPLETED |
| Enrolment | 76 |
| Start date | 2014-01 |
| Completion | 2019-12 |
Conditions
- Critical Limb Ischemia
- Diabetic Foot
Interventions
- Pall Celeris System, point of care device for human cell therapy
Primary outcomes
- Amputation-free survival at 1 month — 1 month
rate of non amputated limb 1 month after the intervention - Amputation-free survival at 3 months — 3 months
rate of non amputated limb 3 months after the intervention - Amputation-free survival at 6 months — 6 months
rate of non amputated limb 6 months after the intervention - Amputation-free survival at 12 months — 12 months
rate of non amputated limb 12 months after the intervention - Amputation-free survival at 18 months — 18 months
rate of non amputated limb 18 months after the intervention - Amputation-free survival at 24 months — 24 months
rate of non amputated limb 24 months after the intervention