Status:
COMPLETED
Umbilical Cord Mesenchymal Stem Cells Injection for Peripheral Arterial Disease
Lead Sponsor:
Institute of Hematology & Blood Diseases Hospital, China
Conditions:
Peripheral Arterial Disease
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to assess the safety and efficacy of umbilical cord blood mesenchymal stem cells with peripheral arterial disease.
Detailed Description
The present study is designed to implant UCB-MSC in patients with CLI, which are resulted from peripheral arterial disease,such as thromboangiitis obliterans, atherosclerosis obliterans and diabetic f...
Eligibility Criteria
Inclusion
- Age of 18-75 years
- Patients confirmed diagnosed peripheral vascular disease , ankle-brachial index \< 0.9
- Poor distal arterial outflow tract
- Patient had at least 3 months conservative treatment ,which resulted in little or no improvement
- Poor physical condition can not tolerate surgery
- Patients are willing to participate in the study and sign the informed consent.
Exclusion
- Renal function damage (over 2 X upper normal range) Liver function damage (over 3 X upper normal range )
- Severe or acute organ damage
- Presence of malignancy
- Pregnancy or lactating patients
- HIV positive
- ABI≧0.9
- A history of severe allergies related cell therapy
- Conservative treatment \< 3 months
- Acute limb ischemia
- Local obvious infection uncontrolled
- Alcoholics or drug abusers within a year
- Severe psychiatric disorder.
- Patients need surgical treatment
- Above the ankle gangrene
- Patients with other factors which were considered not to be suitable to participate in the study by the investigators.
Key Trial Info
Start Date :
February 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 26 2022
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT02287831
Start Date
February 1 2014
End Date
December 26 2022
Last Update
February 8 2023
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