We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00872326
First Posted: March 31, 2009
Last Update Posted: November 14, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Carlos III Health Institute
Information provided by (Responsible Party):
Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud
  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: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I/II Study of Regenerative Cell Therapy in Treating Diabetic Patients With Critical Limb Ischemia

Further study details as provided by Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud:

Primary Outcome Measures:
  • Angiographic evaluation of angiogenesis and vasculogenesis at target limb [ Time Frame: 3 months ]

Secondary Outcome Measures:
  • Ankle-Brachial pressure index [ Time Frame: 3 months ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00872326


Locations
Spain
University Hospital Virgen Macarena
Seville, Spain, 41007
Sponsors and Collaborators
Andalusian Initiative for Advanced Therapies - 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud
ClinicalTrials.gov Identifier: NCT00872326     History of Changes
Other Study ID Numbers: C/ICPD/2007
FPS C/ICPD/2007
First Submitted: March 30, 2009
First Posted: March 31, 2009
Last Update Posted: November 14, 2014
Last Verified: November 2014

Keywords provided by Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud:
Diabetes Complications
Lower limb ischemia
Adult stem cells

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