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Completed

NCT Number: NCT00872326

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

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.

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Key information

Conditions

Peripheral Vascular Diseases Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Foot Diabetic Neuropathies Endocrine System Diseases Foot Ulcer Leg Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

University Hospital Virgen Macarena

Seville, 41007, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Autologous Bone Marrow Mononuclear Cells

Procedure

Infusion > 80 millions mononuclear cells. Intraarterial administration at popliteal artery level. Infusion during 3 minutes with antegrade blockage of arterial flow.

Primary outcomes

  1. Angiographic evaluation of angiogenesis and vasculogenesis at target limb

    Time frame: 3 months

Secondary outcomes

  1. Ankle-Brachial pressure index

    Time frame: 3 months

Sponsors and collaborators

Lead sponsor

Andalusian Network for Design and Translation of Advanced Therapies

Other

Collaborators

  • Carlos III Health Institute

Registry information

Official study title

Phase I/II Study of Regenerative Cell Therapy in Treating Diabetic Patients With Critical Limb Ischemia

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Mar 31, 2009
Registry last updated
Nov 14, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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