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 |
|---|---|
| Rohto Pharmaceutical Co., Ltd. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Ischemic cardiomyopathy undergoing coronary artery bypass surgery
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group of subjects undergoing cell transplantation | Experimental |
| |
| Group of subjects undergoing sham operation | Sham Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ADR-002K administration | Biological | ADR-002K administration |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with Adverse event | Safety assessment related to adverse events and this product | 26 weeks |
| Amount of change in late gadolinium contrast-enhanced area at the time of screening and 6 months after surgery | Efficacy (Exploratory) | 26 weeks |
| Number of complication associated with drug administration method | Feasibility of drug administration method | 26 weeks |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Daisuke Mori, Ph.D | Contact | +81-6-6879-3154 | daimolion@gmail.com | |
| Masao Sasai, Ph.D | Contact | +81-6-6879-3154 | sasai-masao@tissue.med.osaka-u.ac.jp |
| Name | Affiliation | Role |
|---|---|---|
| Daisuke Mori, Ph.D | Osaka University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Osaka University Hospital | Recruiting | Suita | Osaka | 5650871 | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39623426 | Derived | Kawamura T, Yoshioka D, Kawamura A, Misumi Y, Taguchi T, Mori D, Saito S, Yamauchi T, Hata H, Miyagawa S. Safety and therapeutic potential of allogeneic adipose-derived stem cell spray transplantation in ischemic cardiomyopathy: a phase I clinical trial. J Transl Med. 2024 Dec 2;22(1):1091. doi: 10.1186/s12967-024-05816-1. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided