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

This study has been completed.
Sponsor:
Collaborator:
Carlos III Health Institute
Information provided by:
Fundación Pública Andaluza Progreso y Salud
ClinicalTrials.gov Identifier:
NCT00872326
First received: March 30, 2009
Last updated: September 17, 2009
Last verified: September 2009
History of Changes
  Purpose

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.


Condition Intervention Phase
Peripheral Vascular Diseases
Diabetic Foot
 Procedure: Autologous Bone Marrow Mononuclear Cells
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase I/II Study of Regenerative Cell Therapy in Treating Diabetic Patients With Critical Limb Ischemia

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Fundación Pública Andaluza Progreso y Salud:

Primary Outcome Measures:
  • Angiographic evaluation of angiogenesis and vasculogenesis at target limb [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Ankle-Brachial pressure index [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: December 2007
Study Completion Date: May 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Autologous Bone Marrow Mononuclear Cells
Consecutive inclusion among diabetic patients with critical limb ischemia. Intraarterial infusion of autologous bone marrow mononuclear cells
 Procedure: Autologous Bone Marrow Mononuclear Cells
Infusion > 80 millions mononuclear cells. Intraarterial administration at popliteal artery level. Infusion during 3 minutes with antegrade blockage of arterial flow.

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.
  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00872326

Locations
Spain
University Hospital Virgen Macarena
Seville, Spain, 41007
Sponsors and Collaborators
Fundación Pública Andaluza Progreso y Salud
Carlos III Health Institute
Investigators
Principal Investigator: Antonio de la Cuesta, MD Critical Limb Ischemia Unit. Hospital Universitario Virgen Macarena and Hospital San Lazaro
Principal Investigator: Manuel Constantino, PhD Chief of Hematology. Hospital Universitario Virgen Macarena
Principal Investigator: Rafael J Ruiz-Salmeron, PhD Chief of Endovascular Unit. Hospital Universitario Virgen Macarena
  More Information

No publications provided by Fundación Pública Andaluza Progreso y Salud

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Juan-Jesus Bandera. General Manager, Fundacion Progreso y Salud, Spain
ClinicalTrials.gov Identifier: NCT00872326     History of Changes
Other Study ID Numbers: C/ICPD/2007, FPS C/ICPD/2007
Study First Received: March 30, 2009
Last Updated: September 17, 2009
Health Authority: Spain: Ministry of Health

Keywords provided by Fundación Pública Andaluza Progreso y Salud:
Diabetes Complications
Lower limb ischemia
Adult stem cells

Additional relevant MeSH terms:
Ischemia
Vascular Diseases
Peripheral Vascular Diseases
Peripheral Arterial Disease
Diabetic Foot
Pathologic Processes
Cardiovascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
 Diabetic Angiopathies
Foot Ulcer
Leg Ulcer
Skin Ulcer
Skin Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies

ClinicalTrials.gov processed this record on May 22, 2013