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Umbilical Cord Mesenchymal Stem Cells Injection for Peripheral Arterial Disease

Primary Purpose

Peripheral Arterial Disease

Status

Completed

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

umbilical cord mesenchymal stem cells

About this trial

This is an interventional treatment trial for Peripheral Arterial Disease

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age of 18-75 years
Patients confirmed diagnosed with diabetes secondary to 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
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.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

umbilical cord mesenchymal stem cells

Arm Description

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

Outcomes

Primary Outcome Measures

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 %

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT02287831

First Posted

November 2, 2014

Last Updated

January 25, 2023

Sponsor

Institute of Hematology & Blood Diseases Hospital, China

1. Study Identification

Unique Protocol Identification Number

NCT02287831

Brief Title

Umbilical Cord Mesenchymal Stem Cells Injection for Peripheral Arterial Disease

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Completed

Study Start Date

February 2014 (undefined)

Primary Completion Date

December 2022 (Actual)

Study Completion Date

December 26, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Institute of Hematology & Blood Diseases Hospital, China

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Peripheral Arterial Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

28 (Actual)

8. Arms, Groups, and Interventions

Arm Title

umbilical cord mesenchymal stem cells

Arm Type

Experimental

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

umbilical cord mesenchymal stem cells

Primary Outcome Measure Information:

Title

To evaluate safety and tolerability related to the intramuscular injection of autologous Umbilical cord blood derived stem cells.

Description

Amputation rate and mortality will be combined to report safty in %

Time Frame

6 months

Secondary Outcome Measure Information:

Title

To evaluate effectiveness related to the intramuscular injection of autologous Umbilical cord blood derived stem cells.

Description

Rest pain, temperature of skin and cold feeling will be combined to report effectiveness in score.

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Pingping Huang, M.D.

Organizational Affiliation

Institute of Hematology & Blood Diseases Hospital, China

Official's Role

Principal Investigator

12. IPD Sharing Statement

Learn more about this trial

Umbilical Cord Mesenchymal Stem Cells Injection for Peripheral Arterial Disease

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