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

NCT00872326 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2014-11-14

No results posted yet for this study

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.

Conditions

  • Peripheral Vascular Diseases
  • Diabetic Foot

Interventions

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.

Sponsors & Collaborators

  • Carlos III Health Institute

    collaborator OTHER_GOV

  • Andalusian Network for Design and Translation of Advanced Therapies

    lead OTHER

Principal Investigators

  • Antonio de la Cuesta, MD · Critical Limb Ischemia Unit. Hospital Universitario Virgen Macarena and Hospital San Lazaro

  • Manuel Constantino, PhD · Chief of Hematology. Hospital Universitario Virgen Macarena

  • Rafael J Ruiz-Salmeron, PhD · Chief of Endovascular Unit. Hospital Universitario Virgen Macarena

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-12-31
Primary Completion
2009-04-30
Completion
2009-05-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00872326 on ClinicalTrials.gov