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The purpose of this study is to evaluate the efficacy and safety of intracoronary injection of JRM-001 after reconstructive surgery in pediatric patients with functional single ventricle
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Autologous cardiac stem cells (JRM-001) | Experimental |
| |
| Usual care | No Intervention |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Autologous cardiac stem cells (JRM-001) | Genetic | 3x 10^5 cells/kg, single treatment |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in ejection fraction (EF(%)) assessed by MRI from baseline | Baseline, 6 and 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in EF(%) assessed by echocardiograms from baseline | Screening, Baseline, 3, 6 and 12 months | |
| Change in EF(%) assessed by cardiac catheterization from baseline | Baseline, 6 and 12 months | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Metcela Inc. (former Japan Regenerative Medicine Co., Ltd.) | Contact | info@j-rm.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kanagawa Children's Medical Center | Recruiting | Kanagawa | Japan | |||
| Okayama University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25403163 | Background | Ishigami S, Ohtsuki S, Tarui S, Ousaka D, Eitoku T, Kondo M, Okuyama M, Kobayashi J, Baba K, Arai S, Kawabata T, Yoshizumi K, Tateishi A, Kuroko Y, Iwasaki T, Sato S, Kasahara S, Sano S, Oh H. Intracoronary autologous cardiac progenitor cell transfer in patients with hypoplastic left heart syndrome: the TICAP prospective phase 1 controlled trial. Circ Res. 2015 Feb 13;116(4):653-64. doi: 10.1161/CIRCRESAHA.116.304671. Epub 2014 Nov 17. | |
| 26232942 |
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| ID | Term |
|---|---|
| D018636 | Hypoplastic Left Heart Syndrome |
| D000080039 | Univentricular Heart |
| D006330 | Heart Defects, Congenital |
| ID | Term |
|---|---|
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
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| Change in Ea/Ees assessed by cardiac catheterization from baseline |
| Baseline, 6 and 12 months |
| Change in Ventricular Stiffness assessed by cardiac catheterization from baseline | Baseline, 6 and 12 months |
| Change in heart failure index from baseline | Baseline, 3, 6 and 12 months |
| Change in Quality of Life (QOL) index from baseline | Baseline, 6 and 12 months |
| Number of adverse events | Up to 12 months |
| Recruiting |
| Okayama |
| Japan |
| Saitama Prefectural Children's Medical Center | Recruiting | Saitama | Japan |
| Shizuoka Children's Hospital | Recruiting | Shizuoka | Japan |
| Background |
| Tarui S, Ishigami S, Ousaka D, Kasahara S, Ohtsuki S, Sano S, Oh H. Transcoronary infusion of cardiac progenitor cells in hypoplastic left heart syndrome: Three-year follow-up of the Transcoronary Infusion of Cardiac Progenitor Cells in Patients With Single-Ventricle Physiology (TICAP) trial. J Thorac Cardiovasc Surg. 2015 Nov;150(5):1198-1207, 1208.e1-2. doi: 10.1016/j.jtcvs.2015.06.076. Epub 2015 Jul 8. |
| 28052915 | Background | Ishigami S, Ohtsuki S, Eitoku T, Ousaka D, Kondo M, Kurita Y, Hirai K, Fukushima Y, Baba K, Goto T, Horio N, Kobayashi J, Kuroko Y, Kotani Y, Arai S, Iwasaki T, Sato S, Kasahara S, Sano S, Oh H. Intracoronary Cardiac Progenitor Cells in Single Ventricle Physiology: The PERSEUS (Cardiac Progenitor Cell Infusion to Treat Univentricular Heart Disease) Randomized Phase 2 Trial. Circ Res. 2017 Mar 31;120(7):1162-1173. doi: 10.1161/CIRCRESAHA.116.310253. Epub 2017 Jan 4. |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |