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
  Purpose

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).


Condition Intervention Phase
Autologous Transplantation
Diabetic Foot
Biological: Symptoms and Objective Examination
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Autologous Transplantation of Bone Marrow Mesenchymal Stem Cells and Mononuclear Cells on Diabetic Critical Limb Ischemia and Foot Ulcer

Resource links provided by NLM:


Further study details as provided by Third Military Medical University:

Primary Outcome Measures:
  • Magnetic resonance angiography [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: August 2009
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Symptoms and Objective Examination 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

Detailed 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

  Eligibility

Ages Eligible for Study:   40 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00955669

Locations
China, Chongqing
the southwest Hospital
Chongqing, Chongqing, China, 400038
Sponsors and Collaborators
Third Military Medical University
Investigators
Study Director: Chen bing, doctor Endocrinology and Metabolism Department, the south west Hospital of the Third Military Medical University
  More Information

No publications provided

Responsible Party: Department of Endocrinology and Metabolism, Southwest Hospital, Third Military Medical University, Chongqing, China
ClinicalTrials.gov Identifier: NCT00955669     History of Changes
Other Study ID Numbers: ldb2008101
Study First Received: August 4, 2009
Last Updated: November 30, 2010
Health Authority: China: Ethics Committee

Keywords provided by Third Military Medical University:
mesenchymal stem cells
mononuclear cells

Additional relevant MeSH terms:
Ischemia
Foot Ulcer
Diabetic Foot
Pathologic Processes
Foot Diseases
Skin Diseases
Leg Ulcer
Skin Ulcer
Diabetic Angiopathies
Vascular Diseases
Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases
Diabetic Neuropathies

ClinicalTrials.gov processed this record on July 20, 2014