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

This study has been completed.
Sponsor:
Information provided by:
Third Military Medical University
ClinicalTrials.gov Identifier:
NCT00955669
First received: August 4, 2009
Last updated: November 30, 2010
Last verified: November 2010

August 4, 2009
November 30, 2010
August 2009
August 2010   (final data collection date for primary outcome measure)
Magnetic resonance angiography [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
Patients in both group received the same conventional treatment. Meanwhile, mesenchymal stem cells were separated by density gradient centrifugation and cultured in the medium with autologous serum.After three-weeks adherent culture in vitro, mesenchymal [ Time Frame: 180 days ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00955669 on ClinicalTrials.gov Archive Site
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Comparison of Autologous Mesenchymal Stem Cells and Mononuclear Cells on Diabetic Critical Limb Ischemia and Foot Ulcer
Comparison of Autologous Transplantation of Bone Marrow Mesenchymal Stem Cells and Mononuclear Cells on Diabetic Critical Limb Ischemia and Foot Ulcer

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).

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

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Autologous Transplantation
  • Diabetic Foot
Biological: Symptoms and Objective Examination
5.0*108~5.0*109 MSCs and MNCs were transplant into impaired lower limbs by intramuscular injection
Other Name: transplant
Active Comparator: Symptoms and Objective Examination
Intervention: Biological: Symptoms and Objective Examination
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
August 2010
August 2010   (final data collection date for primary outcome measure)

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
Both
40 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
China
 
NCT00955669
ldb2008101
Yes
Department of Endocrinology and Metabolism, Southwest Hospital, Third Military Medical University, Chongqing, China
Third Military Medical University
Not Provided
Study Director: Chen bing, doctor Endocrinology and Metabolism Department, the south west Hospital of the Third Military Medical University
Third Military Medical University
November 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP