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

A

Andalusian Network for Design and Translation of Advanced Therapies

Status and phase

Completed
Phase 2
Phase 1

Conditions

Diabetic Foot
Peripheral Vascular Diseases

Treatments

Procedure: Autologous Bone Marrow Mononuclear Cells

Study type

Interventional

Funder types

Other

Identifiers

NCT00872326
C/ICPD/2007
FPS C/ICPD/2007

Details and patient eligibility

About

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.

Full 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.

Enrollment

20 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

20 participants in 1 patient group

Autologous Bone Marrow Mononuclear Cells
Experimental group
Description:
Consecutive inclusion among diabetic patients with critical limb ischemia. Intraarterial infusion of autologous bone marrow mononuclear cells
Treatment:
Procedure: Autologous Bone Marrow Mononuclear Cells

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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