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Comparison of Autologous Mesenchymal Stem Cells and Mononuclear Cells on Diabetic Critical Limb Ischemia and Foot Ulcer

NCT00955669 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2010-12-01

No results posted yet for this study

Summary

Objective:

To compare the effect and safety of autologous transplantation of bone marrow mesenchymal stem cells(MSCs) and mononuclear cells(MNCs) on Diabetic patients with Critical Limb Ischemia and Foot Ulcer.

Methods:

patients were randomized into the A group and the B group by use of a randomization table. One lower limb in A group or in B group was selected randomly for MSCs or MNCs transplantation as MSCs or MNCs group, the other lower limb in the same patient was selected for placebo（normal saline ,NS）injection as NS group.

The whole procedures of this clinical trial were blinded to both patients and investigators.Patients in both groups received the same ordinary treatment. Meanwhile, MSCs and MNCs were transplanted into the impaired lower limbs respectively. Follow-up index include: efficacy (pain,ulcer healing rate, lower limb amputation rate and ,ankle-brachial index,Transcutaneous oxygen pressure,magnetic resonance angiography) and safety (infection of the injection site, immunological rejection, and tumour generation).

Conditions

  • Autologous Transplantation
  • Diabetic Foot

Interventions

BIOLOGICAL

Symptoms and Objective Examination

5.0\*108\~5.0\*109 MSCs and MNCs were transplant into impaired lower limbs by intramuscular injection

Sponsors & Collaborators

  • Third Military Medical University

    lead OTHER

Principal Investigators

  • Chen bing, doctor · Endocrinology and Metabolism Department, the south west Hospital of the Third Military Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-08-31
Primary Completion
2010-08-31
Completion
2010-08-31

Countries

  • China

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 NCT00955669 on ClinicalTrials.gov