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NCT02287831 Clinical Trial

Umbilical Cord Mesenchymal Stem Cells Injection for Peripheral Arterial Disease

Peripheral Arterial Disease Clinical Trial

Official title:
Safety and Efficacy of Umbilical Cord Mesenchymal Stem Cell Injection for Peripheral Arterial Disease

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02287831
Other study ID # 13ZCZDSY02200
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received
Last updated
Start date February 2014
Est. completion date December 26, 2022

Study information
Verified date January 2023
Source Institute of Hematology & Blood Diseases Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The purpose of this study is to assess the safety and efficacy of umbilical cord blood mesenchymal stem cells with peripheral arterial disease.

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 foot, and to evaluate the safety and efficacy of the implantation procedure.

Recruitment information / eligibility
Status Completed
Enrollment 28
Est. completion date December 26, 2022
Est. primary completion date December 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: 1. Age of 18-75 years 2. Patients confirmed diagnosed peripheral vascular disease , ankle-brachial index < 0.9 3. Poor distal arterial outflow tract 4. Patient had at least 3 months conservative treatment ,which resulted in little or no improvement 5. Poor physical condition can not tolerate surgery 6. Patients are willing to participate in the study and sign the informed consent. Exclusion Criteria: 1. Renal function damage (over 2 X upper normal range) Liver function damage (over 3 X upper normal range ) 2. Severe or acute organ damage 3. Presence of malignancy 4. Pregnancy or lactating patients 5. HIV positive 6. ABI?0.9 7. A history of severe allergies related cell therapy 8. Conservative treatment < 3 months 9. Acute limb ischemia 10. Local obvious infection uncontrolled 11. Alcoholics or drug abusers within a year 12. Severe psychiatric disorder. 13. Patients need surgical treatment 14. Above the ankle gangrene 15. Patients with other factors which were considered not to be suitable to participate in the study by the investigators.

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• umbilical cord mesenchymal stem cells

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Institute of Hematology & Blood Diseases Hospital

Outcome
Type Measure Description Time frame Safety issue
Primary To evaluate safety and tolerability related to the intramuscular injection of autologous Umbilical cord blood derived stem cells. Amputation rate and mortality will be combined to report safty in % 6 months
Secondary To evaluate effectiveness related to the intramuscular injection of autologous Umbilical cord blood derived stem cells. Rest pain, temperature of skin and cold feeling will be combined to report effectiveness in score. 6 months
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