Human Umbilical-Cord-Derived Mesenchymal Stem Cell Therapy in Ischemic Cardiomyopathy (UCMSC-Heart)
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|ClinicalTrials.gov Identifier: NCT02439541|
Recruitment Status : Unknown
Verified March 2016 by Affiliated Hospital to Academy of Military Medical Sciences.
Recruitment status was: Recruiting
First Posted : May 8, 2015
Last Update Posted : March 16, 2016
|Condition or disease||Intervention/treatment||Phase|
|Chronic Ischemic Heart Disease Heart Failure Angina||Biological: UCMSC group||Phase 1 Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Safety and Efficacy of Human Umbilical-Cord-derived Mesenchymal Stem Cell Transplantation in Ischemic Cardiomyopathy|
|Study Start Date :||May 2015|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||December 2018|
Experimental: UCMSC group
Patients in this arm received umbilical cord MSCs by intracoronary injection
Biological: UCMSC group
Human umbilical cord MSCs are transplanted by intracoronary infusion(1×10^7)
No Intervention: Control group
Patients in this arm did not receive any intervention.
- Number and nature of adverse events [ Time Frame: Within the first year after intracoronary infusion ]Evidence for new clinical/biological abnormalities.
- Incidence of major adverse coronary events (MACE) [ Time Frame: Within the first year after intracoronary infusion ]Major adverse coronary events (MACE) were defined as cardiac death, non-fatal myocardial infarction, or rehospitalization for acute coronary syndrome and for congestive heart failure.
- Exercise Time and Level [ Time Frame: Post cell transplantation: 1, 3, 6, 12 months ]Exercise time and level as assessed via six minute walk test.
- Quantify myocardium perfusion measured by SPECT [ Time Frame: Post cell transplantation: 6, 12 months ]The efficacy of UC-MSC treatment was quantified by the differences between the two groups and from baseline to 6 and 12 months in perfusion images, as measured by SPECT.
- Assessment of heart function by left ventricular ejection fraction [ Time Frame: Post cell transplantation: 1, 3, 6，12 months ]Change in left ventricular ejection fraction was assessed with echocardiography after cell implantation.
- Clinical Improvement in NYHA Classification [ Time Frame: 1 year ]The NYHA scale ranges from 1 (best)"Mild- no limitation of physical activity due to heart failure" to 4 (worst) "Severe-Unable to carry out any physical activity without discomfort due to heart failure".
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02439541
|Contact: Xiaozhong Zhang, M.Dfirstname.lastname@example.org|
|Department of cardiology,Affiliated Hospital to Academy of Military Medical Sciences||Recruiting|
|Beijing, China, 100071|
|Contact: Xiaozhong Zhang, M.D +86-010-66947136 email@example.com|
|Study Chair:||Bing Liu, M.D||307-IVY Translational Medicine Center|
|Principal Investigator:||Xiaozhong Zhang, M.D||Department of cardiology,Affiliated Hospital to Academy of Military Medical Sciences|