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| Name | Class |
|---|---|
| Ivy Institute of Stem Cells Co. Ltd | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| UCMSC group | Experimental | Patients in this arm received umbilical cord MSCs by intracoronary injection |
|
| Control group | No Intervention | Patients in this arm did not receive any intervention. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| UCMSC group | Biological | Human umbilical cord MSCs are transplanted by intracoronary infusion(1×10^7) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number and nature of adverse events | Evidence for new clinical/biological abnormalities. | Within the first year after intracoronary infusion |
| Incidence of major adverse coronary events (MACE) | 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. | Within the first year after intracoronary infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Exercise Time and Level | Exercise time and level as assessed via six minute walk test. | Post cell transplantation: 1, 3, 6, 12 months |
| Quantify myocardium perfusion measured by SPECT | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xiaozhong Zhang, M.D | Contact | +86-010-66947136 | zxz947136@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Bing Liu, M.D | 307-IVY Translational Medicine Center | Study Chair |
| Xiaozhong Zhang, M.D | Department of cardiology,Affiliated Hospital to Academy of Military Medical Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of cardiology,Affiliated Hospital to Academy of Military Medical Sciences | Recruiting | Beijing | 100071 | China |
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| ID | Term |
|---|---|
| D006333 | Heart Failure |
| D000787 | Angina Pectoris |
| D017202 | Myocardial Ischemia |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D002637 | Chest Pain |
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| Post cell transplantation: 6, 12 months |
| Assessment of heart function by left ventricular ejection fraction | Change in left ventricular ejection fraction was assessed with echocardiography after cell implantation. | Post cell transplantation: 1, 3, 6，12 months |
| Clinical Improvement in NYHA Classification | 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". | 1 year |
| D010146 |
| Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |