NCT02287831CompletedPhase 1
Safety and Efficacy of Umbilical Cord Mesenchymal Stem Cell Injection for Peripheral Arterial Disease
Institute of Hematology & Blood Diseases Hospital, China0 sites28 target enrollmentStarted: February 2014Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 28
- Primary Endpoint
- To evaluate safety and tolerability related to the intramuscular injection of autologous Umbilical cord blood derived stem cells.
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •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.
Outcomes
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.(6 months)
Investigators
Pingping Huang,MD
M.D.
Institute of Hematology & Blood Diseases Hospital, China
Similar Trials
Unknown
Phase 1
Umbilical Cord Mesenchymal Stem Cells Infusion Via Hepatic Artery in Cirrhosis PatientsRadiologyMesenchymal Stem CellsUmbilical CordLiver CirrhosisNCT01224327Qingdao University50
Unknown
Phase 1
Umbilical Cord Mesenchymal Stem Cells Injection for Diabetic FootCritical Limb IschemiaMesenchymal Stem CellsUmbilical CordDiabetic FootNCT01216865Qingdao University50
Unknown
Phase 1
Umbilical Cord Mesenchymal Stem Cells Infusion for Ulcerative ColitisMesenchymal Stem CellsUmbilical CordUlcerative ColitisNCT01221428Qingdao University50
Unknown
Phase 1
Umbilical Cord Mesenchymal Stem Cells Infusion for Initial Type 1 Diabetes MellitusDiabetes Mellitus, Type 1Mesenchymal Stem CellsUmbilical CordDiabetes MellitusNCT01219465Qingdao University50
Unknown
Phase 1
Human Umbilical Cord-Mesenchymal Stem Cells for Hepatic CirrhosisHepatic CirrhosisNCT02652351Shenzhen Hornetcorn Bio-technology Company, LTD20