Comparison of Autologous Mesenchymal Stem Cells and Mononuclear Cells on Diabetic Critical Limb Ischemia and Foot Ulcer
NCT ID: NCT00955669
Last Updated: 2010-12-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
40 participants
INTERVENTIONAL
2009-08-31
2010-08-31
Brief Summary
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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).
Detailed Description
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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
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Symptoms and Objective Examination
Symptoms and Objective Examination
5.0\*108\~5.0\*109 MSCs and MNCs were transplant into impaired lower limbs by intramuscular injection
Interventions
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Symptoms and Objective Examination
5.0\*108\~5.0\*109 MSCs and MNCs were transplant into impaired lower limbs by intramuscular injection
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Type 2 diabetic patients
* bilateral critical limb ischemia(ABI from 0.30 to 0.60)
* at least with one foot ulcer
Exclusion Criteria
* malignant tumor
* severe coronary,cerebral and renal vascular disease
40 Years
70 Years
ALL
No
Sponsors
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Third Military Medical University
OTHER
Responsible Party
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Department of Endocrinology and Metabolism, Southwest Hospital, Third Military Medical University, Chongqing, China
Principal Investigators
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Chen bing, doctor
Role: STUDY_DIRECTOR
Endocrinology and Metabolism Department, the south west Hospital of the Third Military Medical University
Locations
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the southwest Hospital
Chongqing, Chongqing Municipality, China
Countries
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References
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Lu D, Jiang Y, Deng W, Zhang Y, Liang Z, Wu Q, Jiang X, Zhang L, Gao F, Cao Y, Chen B, Xue Y. Long-Term Outcomes of BMMSC Compared with BMMNC for Treatment of Critical Limb Ischemia and Foot Ulcer in Patients with Diabetes. Cell Transplant. 2019 May;28(5):645-652. doi: 10.1177/0963689719835177. Epub 2019 Mar 27.
Chen Y, Ma Y, Li N, Wang H, Chen B, Liang Z, Ren R, Lu D, Boey J, Armstrong DG, Deng W. Efficacy and long-term longitudinal follow-up of bone marrow mesenchymal cell transplantation therapy in a diabetic patient with recurrent lower limb bullosis diabeticorum. Stem Cell Res Ther. 2018 Apr 10;9(1):99. doi: 10.1186/s13287-018-0854-9.
Other Identifiers
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ldb2008101
Identifier Type: -
Identifier Source: org_study_id