Umbilical Cord Mesenchymal Stem Cells Injection for Peripheral Arterial Disease
Safety and Efficacy of Umbilical Cord Mesenchymal Stem Cell Injection for Peripheral Arterial Disease
1 other identifier
interventional
28
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Feb 2014
Longer than P75 for phase_1
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2014
CompletedFirst Submitted
Initial submission to the registry
November 2, 2014
CompletedFirst Posted
Study publicly available on registry
November 11, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 26, 2022
CompletedFebruary 8, 2023
January 1, 2023
8.8 years
November 2, 2014
January 25, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
To evaluate effectiveness related to the intramuscular injection of autologous Umbilical cord blood derived stem cells.
6 months
Study Arms (1)
umbilical cord mesenchymal stem cells
EXPERIMENTALMultiple intra muscular injection of mesenchymal stem cells derived from human umbilical cord.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Pingping Huang, M.D.
Institute of Hematology & Blood Diseases Hospital, China
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- M.D.
Study Record Dates
First Submitted
November 2, 2014
First Posted
November 11, 2014
Study Start
February 1, 2014
Primary Completion
December 1, 2022
Study Completion
December 26, 2022
Last Updated
February 8, 2023
Record last verified: 2023-01