Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The study is designed to assess the safety and efficacy of allogeneic human umbilical cord-derived mesenchymal stem cells (hUC-MSCs) with injectable collagen scaffold transplanted into patients with chronic ischemic cardiomyopathy.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| hUC-MSCs+Injectable collagen scaffold+CABG | Experimental |
| |
| hUC-MSCs+CABG | Active Comparator |
| |
| CABG | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hUC-MSCs+Injectable collagen scaffold+CABG | Biological | Patients underwent Coronary Artery Bypass Surgery (CABG) with 10^8 allogeneic human umbilical cord mesenchymal stem cells (hUC-MSCs) in collagen scaffold injecting in the infarct region. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of treatment-emergent adverse events | Adverse events (AEs), serious adverse events (SAEs) and changes in vital signs, electrocardiogram (ECG) and laboratory values were measured. | up to 24 months after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Myocardial blood flow | Change in myocardial blood flow evaluated by Cardiac magnetic resonance imaging (MRI). | 1, 3, 6, 12 and 24 months |
| Left ventricle ejection fraction (LVEF) | Change in LVEF as measured by ultrasonic cardiogram (UCG) and Cardiac magnetic resonance imaging (MRI). |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jianwu Dai, Ph.D. | Chinese Academy of Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | Nanjing | Jiangsu | 210008 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32910197 | Derived | He X, Wang Q, Zhao Y, Zhang H, Wang B, Pan J, Li J, Yu H, Wang L, Dai J, Wang D. Effect of Intramyocardial Grafting Collagen Scaffold With Mesenchymal Stromal Cells in Patients With Chronic Ischemic Heart Disease: A Randomized Clinical Trial. JAMA Netw Open. 2020 Sep 1;3(9):e2016236. doi: 10.1001/jamanetworkopen.2020.16236. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| hUC-MSCs+CABG | Biological | Patients underwent Coronary Artery Bypass Surgery (CABG) with 10^8 allogeneic human umbilical cord mesenchymal stem cells (hUC-MSCs) injecting in the infarct region. |
|
| CABG | Procedure | Patients underwent CABG alone. |
|
| 1, 3, 6, 12 and 24 months |
| Infarct size | Change in infarct size evaluated by Cardiac magnetic resonance imaging (MRI). | 1, 3, 6, 12 and 24 months |
| New York Heart Association (NYHA) Functional Classification | Change in clinical symptoms evaluated by NYHA. | 1, 3, 6, 12 and 24 months |
| Canadian Cardiovascular Society (CCS) Angina Grading Scale | Change in clinical symptoms evaluated by CCS. | 1, 3, 6, 12 and 24 months |