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Stem Cell Study for Patients With Leg Ulcer/Gangrene

NCT00221143 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2009-02-09

No results posted yet for this study

Summary

The purpose of this study is to determine if stem cell therapy with one's own cells (autologous cells) delivered intramuscularly to one's leg with ulcer and/or gangrene due to poor blood flow will be safe and if it will relieve leg pain, increase blood flow, and/or cure the leg wound.

Conditions

  • Leg Pain
  • Ulcer
  • Gangrene
  • Ischemia
  • Peripheral Vascular Diseases

Interventions

GENETIC

Autologous peripheral blood CD34 positive cell therapy

Sponsors & Collaborators

  • Institute of Biomedical Research and Innovation, Kobe, Hyogo, Japan

    collaborator OTHER

  • Kobe City General Hospital

    collaborator OTHER

  • Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan

    lead OTHER

Principal Investigators

  • Takayuki Asahara, M.D. · Institute of Biomedical Research and Innovation, Kobe, Hyogo, Japan

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-11-30
Completion
2008-01-31

Countries

  • Japan

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 NCT00221143 on ClinicalTrials.gov