Umbilical Cord Mesenchymal Stem Cells Injection for Diabetes Secondary Peripheral Arterial Disease
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|ClinicalTrials.gov Identifier: NCT02287831|
Recruitment Status : Unknown
Verified February 2016 by Pingping Huang, Institute of Hematology & Blood Diseases Hospital.
Recruitment status was: Enrolling by invitation
First Posted : November 11, 2014
Last Update Posted : February 25, 2016
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Peripheral Arterial Disease||Biological: umbilical cord mesenchymal stem cells||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Safety and Efficacy of Umbilical Cord Mesenchymal Stem Cell Injection for Diabetes Secondary Peripheral Arterial Disease|
|Study Start Date :||February 2014|
|Estimated Primary Completion Date :||June 2016|
Experimental: umbilical cord mesenchymal stem cells
Multiple intra muscular injection of mesenchymal stem cells derived from human umbilical cord.
Biological: umbilical cord mesenchymal stem cells
patients were divided into 3 dose treatment groups (6.29 × 107,9.43 × 107 and 14.15 × 107 cells/m2). After 4 and 8 weeks, patients were injected the same number of cells.
- Angiographic evaluation of angiogenesis at ischemic limb [ Time Frame: 3 months ]
- Ankle-Brachial pressure index [ Time Frame: 3 months ]Self-control,compared with non-treatment ABI≧0.01
- Walking distance [ Time Frame: 3 months ]
- Pain [ Time Frame: 3 months ]Rest pains on rating scales ranged from 0 points for the best (complete relief of pain with no use of analgesics) to 4 points for the worst result.Self-control,compared with non-treatment ,the score≧1.
- Laser Doppler evaluation of blood perfusion at ischemic limb [ Time Frame: 3 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02287831
|Principal Investigator:||Pingping Huang, M.D.||Institute of Hematology & Blood Diseases Hospital|