Autologous Bone Marrow Derived Mononuclear Cells in Treating Diabetic Patients With Critical Limb Ischemia - Full Text View

Sponsors and Collaborators:	Progress and Health Foundation, Spain Carlos III Health Institute
Information provided by:	Progress and Health Foundation, Spain
ClinicalTrials.gov Identifier:	NCT00872326

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 I Phase II

MedlinePlus related topics: Diabetes Complications Diabetic Foot Foot Health Peripheral Arterial Disease Vascular Diseases

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	Phase I/II Study of Regenerative Cell Therapy in Treating Diabetic Patients With Critical Limb Ischemia

Further study details as provided by Progress and Health Foundation, Spain:

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
Estimated Study Completion Date:	January 2011
Estimated Primary Completion Date:	April 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Autologous Bone Marrow Mononuclear Cells: Experimental 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 > 2years

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

Progress and Health Foundation, Spain

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

Responsible Party:	Progress and Health Foundation, Spain ( Juan-Jesus Bandera. General Manager )
Study ID Numbers:	C/ICPD/2007, FPS C/ICPD/2007
Study First Received:	March 30, 2009
Last Updated:	March 30, 2009
ClinicalTrials.gov Identifier:	NCT00872326 History of Changes
Health Authority:	Spain: Ministry of Health

Keywords provided by Progress and Health Foundation, Spain:

Diabetes Complications
Lower limb ischemia
Adult stem cells

Study placed in the following topic categories:

Foot Ulcer
Peripheral Vascular Diseases
Diabetic Neuropathies
Skin Diseases
Ulcer
Vascular Diseases
Diabetes Mellitus
Endocrine System Diseases

Ischemia
Diabetic Angiopathies
Endocrinopathy
Skin Ulcer
Diabetes Complications
Diabetic Foot
Leg Ulcer

Additional relevant MeSH terms:

Foot Ulcer
Peripheral Vascular Diseases
Diabetic Neuropathies
Skin Diseases
Vascular Diseases
Diabetes Mellitus
Endocrine System Diseases
Ischemia

Diabetic Angiopathies
Pathologic Processes
Cardiovascular Diseases
Skin Ulcer
Diabetes Complications
Diabetic Foot
Leg Ulcer

ClinicalTrials.gov processed this record on May 07, 2009