NCT Number: NCT02287831
Umbilical Cord Mesenchymal Stem Cells Injection for Peripheral Arterial Disease
The purpose of this study is to assess the safety and efficacy of umbilical cord blood mesenchymal stem cells with peripheral arterial disease.
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Conditions
Age range
18 year–75 year
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 1 / Phase 2
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Primary outcomes
-
To evaluate safety and tolerability related to the intramuscular injection of autologous Umbilical cord blood derived stem cells.
Time frame: 6 months
Amputation rate and mortality will be combined to report safty in %
Secondary outcomes
-
To evaluate effectiveness related to the intramuscular injection of autologous Umbilical cord blood derived stem cells.
Time frame: 6 months
Rest pain, temperature of skin and cold feeling will be combined to report effectiveness in score.
Sponsors and collaborators
Lead sponsor
Institute of Hematology & Blood Diseases Hospital, China
Other
Registry information
Official study title
Safety and Efficacy of Umbilical Cord Mesenchymal Stem Cell Injection for Peripheral Arterial Disease
Important dates
- Study start
- 2014
- Primary completion
- 2022
- Study completion
- 2022
- First posted
- Nov 11, 2014
- Registry last updated
- Feb 8, 2023
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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