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

Third Military Medical University

Status and phase: Completed; Phase 1

Conditions: Diabetic Foot; Autologous Transplantation

Treatments: Biological: Symptoms and Objective Examination

Study type: Interventional

Funder types: Other

Identifiers

NCT00955669

ldb2008101

Details and patient eligibility

About

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).

Full description

RESEARCH DESIGN AND METHODS Written informed consent was obtained from all subjects. Type 2 diabetic patients with bilateral critical limb ischemia (ankle-brachial index, ABI from 0.30 to 0.60) and at least with one foot ulcer, but without malignant tumor or gangrene above the ankle and/or severe coronary, cerebral and renal vascular disease, were eligible for the participation in this trial. Eligible patients took part in this study on a voluntary basis. They were randomized into the A and B group by use of a randomization table. One lower limb in A group or in B group was selected randomly for BMMSCs or BMMNCs transplantation as BMMSCs or BMMNCs 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.

Preparation of Human Autologous Serum Preparation of MSCs and MNCs Flow Cytometric Analysis Examination of cells Safety Administration of therapy 5.0*108~5.0*109 MSCs and MNCs were transplant into impaired lower limbs by intramuscular injection.

observation index and assessment guidelines Statistical analysis

Enrollment: 40 patients

Sex: All

Ages: 40 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age from 40 to 70 years
• Type 2 diabetic patients
• bilateral critical limb ischemia(ABI from 0.30 to 0.60)
• at least with one foot ulcer

Exclusion criteria

• dry gangrene above the ankle or moist gangrene
• malignant tumor
• severe coronary,cerebral and renal vascular disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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40 participants in 1 patient group

Symptoms and Objective Examination

Active Comparator group

Treatment:

Biological: Symptoms and Objective Examination