Umbilical Cord Mesenchymal Stem Cells Injection for Peripheral Arterial Disease

Phase 1

Completed

• Conditions: Peripheral Arterial Disease
• Interventions: Biological: umbilical cord mesenchymal stem cells

• Registration Number: NCT02287831
• Lead Sponsor: Institute of Hematology & Blood Diseases Hospital, China

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

Study Timeline

• Study Start: 2014-02
• Study First Submitted: 2014-11-02
• Study First Submitted QC: 2014-11-06
• Study First Posted: 2014-11-11
• Primary Completion: 2022-12
• Study Completion: 2022-12-26
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-25
• Last Update Posted: 2023-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
umbilical cord mesenchymal stem cells	umbilical cord mesenchymal stem cells	Multiple intra muscular injection of mesenchymal stem cells derived from human umbilical cord.

Primary Outcome Measures

Name	Time	Method
To evaluate safety and tolerability related to the intramuscular injection of autologous Umbilical cord blood derived stem cells.	6 months	Amputation rate and mortality will be combined to report safty in %

Secondary Outcome Measures

Name	Time	Method
To evaluate effectiveness related to the intramuscular injection of autologous Umbilical cord blood derived stem cells.	6 months	Rest pain, temperature of skin and cold feeling will be combined to report effectiveness in score.