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

Institute of Hematology & Blood Diseases Hospital, China0 sites28 target enrollmentFebruary 2014

ConditionsPeripheral Arterial Disease

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Peripheral Arterial Disease
Sponsor: Institute of Hematology & Blood Diseases Hospital, China
Enrollment: 28
Primary Endpoint: To evaluate safety and tolerability related to the intramuscular injection of autologous Umbilical cord blood derived stem cells.
Status: Completed
Last Updated: 3 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

February 2014

End Date

December 26, 2022

Last Updated

3 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Institute of Hematology & Blood Diseases Hospital, China

Responsible Party

Principal Investigator

Pingping Huang,MD

M.D.

Institute of Hematology & Blood Diseases Hospital, China

Eligibility Criteria

Inclusion Criteria

•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 Criteria

•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
•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