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

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ClinicalTrials.gov Identifier: NCT00872326
Recruitment Status : Completed
First Posted : March 31, 2009
Last Update Posted : November 14, 2014
Sponsor:
Collaborator:
Carlos III Health Institute
Information provided by (Responsible Party):
Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud

Tracking Information
First Submitted Date  ICMJE March 30, 2009
First Posted Date  ICMJE March 31, 2009
Last Update Posted Date November 14, 2014
Study Start Date  ICMJE December 2007
Actual Primary Completion Date April 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 30, 2009)
Angiographic evaluation of angiogenesis and vasculogenesis at target limb [ Time Frame: 3 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT00872326 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 30, 2009)
Ankle-Brachial pressure index [ Time Frame: 3 months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Autologous Bone Marrow Derived Mononuclear Cells in Treating Diabetic Patients With Critical Limb Ischemia
Official Title  ICMJE Phase I/II Study of Regenerative Cell Therapy in Treating Diabetic Patients With Critical Limb Ischemia
Brief Summary 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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Peripheral Vascular Diseases
  • Diabetic Foot
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: Autologous Bone Marrow Mononuclear Cells
Consecutive inclusion among diabetic patients with critical limb ischemia. Intraarterial infusion of autologous bone marrow mononuclear cells
Intervention: Procedure: Autologous Bone Marrow Mononuclear Cells
Publications * Ruiz-Salmeron R, de la Cuesta-Diaz A, Constantino-Bermejo M, Pérez-Camacho I, Marcos-Sánchez F, Hmadcha A, Soria B. Angiographic demonstration of neoangiogenesis after intra-arterial infusion of autologous bone marrow mononuclear cells in diabetic patients with critical limb ischemia. Cell Transplant. 2011;20(10):1629-39. doi: 10.3727/096368910X0177.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 30, 2009)
20
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2009
Actual Primary Completion Date April 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00872326
Other Study ID Numbers  ICMJE C/ICPD/2007
FPS C/ICPD/2007
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud
Study Sponsor  ICMJE Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud
Collaborators  ICMJE Carlos III Health Institute
Investigators  ICMJE
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
PRS Account Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud
Verification Date November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP