Phase I/II Study of Regenerative Cell Therapy in Treating Diabetic Patients With Critical Limb Ischemia
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Peripheral Vascular Diseases
- Sponsor
- Andalusian Network for Design and Translation of Advanced Therapies
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Angiographic evaluation of angiogenesis and vasculogenesis at target limb
- Status
- Completed
- Last Updated
- 11 years ago
Overview
Brief Summary
The aim of this study is to assess the efficacy and safety of autologous transplantation of bone-marrow cells for therapeutic angiogenesis and vasculogenesis in diabetic patients with non-revascularizable critical limb ischemia.
Detailed Description
Phase I/II, prospective, single-center study, with consecutive inclusion of 20 diabetic patients with critical limb ischemia due to bellow-the-knee extensive arterial disease. After the inclusion, patients are submitted to a bone-marrow aspiration (30 ml) under sedation. Autologous bone-marrow mononuclear cells (minimum 80 millions mononuclear cells) are infused intraarterially at popliteal artery by blocking antegrade perfusion during 3 minutes. Clinical and angiographic follow-up will be performed at 3 months after the infusion to assess the efficacy of autologous mononuclear cells transplantation in terms of: * Changes in below-the-knee angiography from baseline to 3 months follow-up. * Changes in Ankle-Brachial pressure Index, transcutaneous oxygen pressure, and size of main ischemic ulcer will be also assessed at target limb.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Diabetic patients under treatment (type I or II)
- •Critical limb ischemia (rest pain and/or non-healing ischemic ulcers lasting more than 4 weeks, and/or Ankle-Brachial Index \< 0,8)
- •Not suitable to be revascularized (surgical and interventional consensus)
Exclusion Criteria
- •Neoplastic disease and/or hematologic disease during the last 2 years
- •Diabetic retinopathy
- •Ischemic ulcer greater than 10 cm2
- •Major amputation at target limb
- •Life expectancy \> 2 years
Outcomes
Primary Outcomes
Angiographic evaluation of angiogenesis and vasculogenesis at target limb
Time Frame: 3 months
Secondary Outcomes
- Ankle-Brachial pressure index(3 months)