Autologous Bone Marrow Derived Mononuclear Cells in Treating Diabetic Patients With Critical Limb Ischemia

Phase 1

Completed

• Conditions: Diabetic Foot; Peripheral Vascular Diseases
• Interventions: Procedure: Autologous Bone Marrow Mononuclear Cells

• Registration Number: NCT00872326
• Lead Sponsor: Andalusian Network for Design and Translation of Advanced Therapies

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.

Study Timeline

• Study Start: 2007-12
• Study First Submitted: 2009-03-30
• Study First Submitted QC: 2009-03-30
• Study First Posted: 2009-03-31
• Primary Completion: 2009-04
• Study Completion: 2009-05
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-13
• Last Update Posted: 2014-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Autologous Bone Marrow Mononuclear Cells	Autologous Bone Marrow Mononuclear Cells	Consecutive inclusion among diabetic patients with critical limb ischemia. Intraarterial infusion of autologous bone marrow mononuclear cells

Primary Outcome Measures

Name	Time	Method
Angiographic evaluation of angiogenesis and vasculogenesis at target limb	3 months

Secondary Outcome Measures

Name	Time	Method
Ankle-Brachial pressure index	3 months

Trial Locations

Locations (1)

University Hospital Virgen Macarena; 🇪🇸 Seville, Spain