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Safety and Efficacy of Autologous Bone Marrow Stem Cells for Lower Extremity Ischemia Treating

NCT01903044 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2017-12-13

No results posted yet for this study

Summary

The purpose of this study is to determine whether autologous bone marrow-derived stem cells are effective in the treatment of lower extremity ischemia.

Conditions

  • Lower Extremity Ischemia
  • Leg Ulcer
  • Peripheral Vascular Disease
  • Diabetic Foot
  • Gangrene

Interventions

PROCEDURE

BM-MNC injection

BM-MNC cells will be injected in aliquots of 1 ml at multiple regions of the leg muscles

Sponsors & Collaborators

  • Instituto de Moléstias Cardiovasculares de São José do Rio Preto, Brazil

    collaborator UNKNOWN

  • Hospital Sao Rafael

    collaborator OTHER

  • Hospital Geral Nacional Enrique Cabrera, Cuba

    collaborator UNKNOWN

  • Instituto de Hematología e Inmunología, Cuba

    collaborator UNKNOWN

  • Fundação Araucária

    collaborator OTHER

  • Pontifícia Universidade Católica do Paraná

    lead OTHER

Principal Investigators

  • Paulo Brofman, PhD · Pontifícia Universidade Católica do Paraná

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
2014-09-30
Primary Completion
2017-03-31
Completion
2018-09-30

Countries

  • Brazil

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 NCT01903044 on ClinicalTrials.gov