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| Name | Class |
|---|---|
| Ruijin Hospital | OTHER |
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B2278 is a human umbilical cord mesenchymal stem cell (HucMSCs) injection derived from the umbilical cord. It has the advantages of stronger immune regulation, stronger expansion capacity, lower immunogenicity, and greater accessibility. The preliminary research results indicated that the B2278 injection promote the polarization of macrophages towards a reparative state through paracrine action, directly promote angiogenesis and inhibited inflammatory responses, thereby exerting effects on myocardial repair and treatment of heart failure, and it is also safe and well-tolerated.
This trial is a multi-center I/II phase clinical trial of the human umbilical cord mesenchymal stem cell injection solution, aiming to explore the dosage and regimen for the intramyocardial injection of B2278 in combination with coronary artery bypass grafting surgery for the treatment of chronic heart failure caused by chronic ischemic cardiomyopathy, and to evaluate the safety, tolerance and efficacy of allogeneic intramyocardial injection of the human umbilical cord mesenchymal stem cell injection solution in patients with chronic ischemic heart failure.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CABG combined with low-dose B2278 | Experimental | CABG combined with B2278 at a dose of 1.0×10^7 cells per patient, intramyocardial injection into the epicardium |
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| CABG combined with midium-dose B2278 | Experimental | CABG combined with B2278 at a dose of 5.0×10^7 cells per patient, intramyocardial injection into the epicardium |
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| CABG combined with high-dose B2278 | Experimental | CABG combined with B2278 at a dose of 2.0×10^8 cells per patient, intramyocardial injection into the epicardium |
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| Only CABG | Experimental | Only CABG surgery |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mesenchymal stem cells(HucMSCs) | Drug | B2278 is mesenchymal stem cells derived from human umbilical cord. |
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| Measure | Description | Time Frame |
|---|---|---|
| In phase I, primary outcome will be measured with safety events including DLT, AE, SAE, TEAE, and MACE. In phase II, primary outcome will be measured with the change in LVEF based on CMR detection after 6 months of administration. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| The changes in left ventricular ejection fraction (LVEF), left ventricular end-diastolic volume (LVEDV), and left ventricular end-systolic volume (LVESV) on CMR compared to the baseline. | 6 months | |
| The changes from baseline of LVEF, left ventricular end-systolic diameter (LVESD), left ventricular end-diastolic diameter (LVEDD), LVEDV, LVESV on UCG |
| Measure | Description | Time Frame |
|---|---|---|
| The change in troponin I (TnI) compared to the baseline | 28 days, 3 months and 6months | |
| The changes from the baseline of high-sensitivity C-reactive protein (hs-CRP), TNF-α, IL-1, and IL-6 | 28 days, 3 months and 6 months |
Inclusion Criteria:
Major exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qiang Zhao | Contact | 86+13701695256 | Zq11607@rjb.com.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine | Recruiting | Shanghai | Shanghai Municipality | 20000 | China |
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| CABG | Procedure | only CABG |
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| 28 days, 3 months and 6 months |
| The proportion of participants with improved LVEF (the proportion of participants whose LVEF increased by ≥10% compared to the baseline and whose LVEF was >40% based on CMR and/or UCG); | 3 months and 6 months |
| The distribution of the New York Heart Association (NYHA) cardiac function classification | 28 days, 3 months and 6 months |
| The proportion of participants with NYHA classification ≤ II level | 28 days, 3months and 6months |
| The changes in the 6-minute walk test (6MWT) results compared to the baseline | 28 days, 3 months and 6months |
| The changes in the Minnesota Heart Failure Quality of Life Questionnaire (MLHFQ) from the baseline | 28 days, 3months and 6months |
| The change in the result of amino-terminal pro-brain natriuretic peptide (NT-proBNP) compared to the baseline | 28 days, 3months and 6months |
| The proportion of participants whose heart failure worsened (requiring hospitalization or emergency treatment due to the aggravation of heart failure symptoms and signs) | 3 months and 6months |
| The changes in perfusion and metabolism of ischemic myocardium during the injection stage as measured by myocardial nuclear imaging (SPECT + PET) compared to the baseline (applicable only to those who have undergone nuclear imaging for determination) | 6 months |
| Changhai Hospital | Not yet recruiting | Shanghai | Shanghai Municipality | China |
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| Shanghai Chest Hospital | Not yet recruiting | Shanghai | Shanghai Municipality | China |
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| Shanghai General Hospital | Recruiting | Shanghai | Shanghai Municipality | China |
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