Clinical trial NCT02439541: Human Umbilical-Cord-Derived Mesenchymal Stem Cell Therapy in Ischemic Cardiomyopathy
Official title: Safety and Efficacy of Human Umbilical-Cord-derived Mesenchymal Stem Cell Transplantation in Ischemic Cardiomyopathy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Chronic Ischemic Heart Disease
Heart Failure
Angina
Keywords: cellular therapy
Chronic ischemic heart disease
phase 1/2 clinical study
human umbilical cord mesenchymal stem cell
ischemic heart disease
allogeneic stem cell transplantation
Lead sponsor: Affiliated Hospital to Academy of Military Medical Sciences
Sponsor class: OTHER
Collaborators: name: Ivy Institute of Stem Cells Co. Ltd
First posted: 2015-05-08
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Phase I-II Clinical Trial-Safety and efficacy of umbilical cord derived mesenchymal stem cells (UC-MSCs) in patients with chronic heart ischemia cohort and perspective study.

Detailed description: Phase I-II Clinical Trial-Safety and efficacy of umbilical-cord-derived mesenchymal stem cell (UC-MSC) in patients with chronic heart ischemia cohort and prospective study.

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.

Eligibility criteria: Inclusion Criteria:

* Age between 18 and 80 y
* 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 liver or renal dysfunction or hemorrhagic diseases not suitable for PCI.
* 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

Primary outcomes:
measure: Number and nature of adverse events
timeFrame: Within the first year after intracoronary infusion
measure: Incidence of major adverse coronary events (MACE)
timeFrame: Within the first year after intracoronary infusion
Secondary outcomes:
measure: Exercise Time and Level
timeFrame: Post cell transplantation: 1, 3, 6, 12 months
measure: Quantify myocardium perfusion measured by SPECT
timeFrame: Post cell transplantation: 6, 12 months
measure: Assessment of heart function by left ventricular ejection fraction
timeFrame: Post cell transplantation: 1, 3, 6，12 months
measure: Clinical Improvement in NYHA Classification
timeFrame: 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Department of cardiology,Affiliated Hospital to Academy of Military Medical Sciences
Study officials:
affiliation: 307-IVY Translational Medicine Center
name: Bing Liu, M.D
role: STUDY_CHAIR
affiliation: Department of cardiology,Affiliated Hospital to Academy of Military Medical Sciences
name: Xiaozhong Zhang, M.D
role: PRINCIPAL_INVESTIGATOR
References: