Human Umbilical-Cord-Derived Mesenchymal Stem Cell Therapy in Ischemic Cardiomyopathy
NCT ID: NCT02439541
Last Updated: 2016-03-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
40 participants
INTERVENTIONAL
2015-05-31
2018-12-31
Brief Summary
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Detailed Description
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Forty patients will be selected and divided into two groups according to patients' willingness to stem cell treatment. The patients who are willing to receive stem cell transplantation will receive UC-MSCs by coronary injection. The patients in control group will not receive any intervention.
Every patient will maintain their standard treatment of chronic heart ischemia, with maximum tolerated dosage without side effects.
The day of infusion will be considered day zero. From that moment, followup will be divided into 0-1,1-3, 3-6, and 6-12 months.
Clinical results will be analyzed after completion of 12 months of followup.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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UCMSC group
Patients in this arm received umbilical cord MSCs by intracoronary injection
UCMSC group
Human umbilical cord MSCs are transplanted by intracoronary infusion(1×10\^7)
Control group
Patients in this arm did not receive any intervention.
No interventions assigned to this group
Interventions
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UCMSC group
Human umbilical cord MSCs are transplanted by intracoronary infusion(1×10\^7)
Eligibility Criteria
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Inclusion Criteria
* No option for PCI or CABG (Angiographies evaluated by an independent interventional cardiologist).
* Maximal tolerable angina and heart failure medication
* NYHA functional classification (I-III)
* Signed informed consent
Exclusion Criteria
* Severe cerebral ischemic stroke or cerebral hemorrhage within 6 month.
* History with malignant disease within 5 y of inclusion or suspected malignity
* Severe heart failure (NYHA functional classification IV)
* Diminished functional capacity for other reasons such as COPD, alcoholic cardiomyopathy, or viral myocarditis
* Clinical significant anemia, leukopenia, leukocytosis,or thrombocythemia
* Clinical significant abnormal prothrombin or partial thromboplastin time or anticoagulation treatment that cannot be paused during treatment
* Patients with reduced immune response or treated with immunosuppressive medication
* Combined with severe infectious diseases
* Pregnant or fertile women
* Socially and mentally disabilities
18 Years
80 Years
ALL
No
Sponsors
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Ivy Institute of Stem Cells Co. Ltd
INDUSTRY
Affiliated Hospital to Academy of Military Medical Sciences
OTHER
Responsible Party
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Principal Investigators
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Bing Liu, M.D
Role: STUDY_CHAIR
307-IVY Translational Medicine Center
Xiaozhong Zhang, M.D
Role: PRINCIPAL_INVESTIGATOR
Department of cardiology,Affiliated Hospital to Academy of Military Medical Sciences
Locations
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Department of cardiology,Affiliated Hospital to Academy of Military Medical Sciences
Beijing, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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307-IVY-SC-001
Identifier Type: -
Identifier Source: org_study_id
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