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| Name | Class |
|---|---|
| Translational Research Center for Medical Innovation, Kobe, Hyogo, Japan | OTHER |
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A phase 1 prospective study to determine the procedural feasibility and safety and preliminary efficacy of intracoronary infusion of cardiosphere-derived cells (CDCs) in patients with dilated cardiomyopathy.
Five consecutive patients will be enrolled to a phase 1 study to verify the procedural feasibility and safety with the CDC infusion group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CDC infusion | Experimental | CDCs infusion by coronary intervention. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CDC infusion | Biological | Injection of CDCs (0.3 million per kg of body weight). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Major Cardiac Adverse Events Related to Transcoronary Infusion of CDCs. | Assessment of major adverse cardiac events include death, sustained/symptomatic ventricular tachycardia, aggravation of heart failure, acute coronary syndrome, unplanned cardiovascular operation for cardiac tamponade and infection in the first month after injection, and serially afterwards. | 6 months after CDC treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Ejection Fraction | To determine the changes in cardiac function by ejection fraction with cardiac MRI evaluation in CDC-treated participants from baseline to 6 months of follow up. | 6 months after protocol treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Shigeru Uemura, M.D., Ph.D. | Shonan Tobu Clinic | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Okayama University Hospital | Okayama | 700-8558 | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 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. | |
| 26232942 |
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| ID | Title | Description |
|---|---|---|
| FG000 | CDC Infusion | CDCs infusion by coronary intervention. CDC infusion: Injection of CDCs (0.3 million per kg of body weight). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Consecutive enrollment of 5 patients to receive CDC infusion
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| ID | Title | Description |
|---|---|---|
| BG000 | CDC Infusion | CDCs infusion by coronary intervention. CDC infusion: Injection of CDCs (0.3 million per kg of body weight). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Major Cardiac Adverse Events Related to Transcoronary Infusion of CDCs. | Assessment of major adverse cardiac events include death, sustained/symptomatic ventricular tachycardia, aggravation of heart failure, acute coronary syndrome, unplanned cardiovascular operation for cardiac tamponade and infection in the first month after injection, and serially afterwards. | Adverse events | Posted | Count of Participants | Participants | 6 months after CDC treatment |
|
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | CDC Infusion | CDCs infusion by coronary intervention. CDC infusion: Injection of CDCs (0.3 million per kg of body weight). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| heart failure | Cardiac disorders | Systematic Assessment |
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Single arm study without placebo control comparator
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Hidemasa Oh | Okayama University Hospital | 086-235-6506 | 6506 | hidemasa@okayama-u.ac.jp |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 9, 2020 | Sep 30, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D002311 | Cardiomyopathy, Dilated |
| ID | Term |
|---|---|
| D006332 | Cardiomegaly |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D009202 | Cardiomyopathies |
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Transcoronary infusion
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| 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. |
| 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. |
| 33298561 | Result | Hirai K, Ousaka D, Fukushima Y, Kondo M, Eitoku T, Shigemitsu Y, Hara M, Baba K, Iwasaki T, Kasahara S, Ohtsuki S, Oh H. Cardiosphere-derived exosomal microRNAs for myocardial repair in pediatric dilated cardiomyopathy. Sci Transl Med. 2020 Dec 9;12(573):eabb3336. doi: 10.1126/scitranslmed.abb3336. |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Cardiac Function | Mean | Standard Deviation | percentage of baseline ejection fraction |
|
| Counts |
|---|
| Participants |
|
|
| Secondary | Change in Ejection Fraction | To determine the changes in cardiac function by ejection fraction with cardiac MRI evaluation in CDC-treated participants from baseline to 6 months of follow up. | Changes in cardiac function | Posted | Mean | Standard Deviation | percentage of ejection fraction | 6 months after protocol treatment |
|
|
|
| 1 |
| 5 |
| 1 |
| 5 |
| 0 |
| 5 |
| infection | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| ischemic event | Cardiac disorders | Systematic Assessment |
|
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| D000083083 |
| Laminopathies |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |