Umbilical Cord Mesenchymal Stem Cells Injection for Peripheral Arterial Disease

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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02287831

Enrollment

Registered

2014-11-11

Start date

2014-02-28

Completion date

2022-12-26

Last updated

2023-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peripheral Arterial Disease

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.

Interventions

BIOLOGICALumbilical cord mesenchymal stem cells

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026