- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00872326
Autologous Bone Marrow Derived Mononuclear Cells in Treating Diabetic Patients With Critical Limb Ischemia
Phase I/II Study of Regenerative Cell Therapy in Treating Diabetic Patients With Critical Limb Ischemia
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
-
-
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Seville, Spain, 41007
- University Hospital Virgen Macarena
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Autologous Bone Marrow Mononuclear Cells
Consecutive inclusion among diabetic patients with critical limb ischemia.
Intraarterial infusion of autologous bone marrow mononuclear cells
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Infusion > 80 millions mononuclear cells.
Intraarterial administration at popliteal artery level.
Infusion during 3 minutes with antegrade blockage of arterial flow.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Angiographic evaluation of angiogenesis and vasculogenesis at target limb
Time Frame: 3 months
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Ankle-Brachial pressure index
Time Frame: 3 months
|
3 months
|
Collaborators and Investigators
Collaborators
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
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Cardiovascular Diseases
- Skin Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Endocrine System Diseases
- Diabetic Angiopathies
- Leg Ulcer
- Skin Ulcer
- Diabetes Complications
- Diabetes Mellitus
- Diabetic Neuropathies
- Atherosclerosis
- Foot Ulcer
- Diabetic Foot
- Vascular Diseases
- Ischemia
- Peripheral Arterial Disease
- Peripheral Vascular Diseases
Other Study ID Numbers
- C/ICPD/2007
- FPS C/ICPD/2007
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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