Transcoronary Infusion of Cardiac Progenitor Cells in Pediatric Dilated Cardiomyopathy (TICAP-DCM)
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|ClinicalTrials.gov Identifier: NCT03129568|
Recruitment Status : Recruiting
First Posted : April 26, 2017
Last Update Posted : October 3, 2018
|Condition or disease||Intervention/treatment||Phase|
|Dilated Cardiomyopathy||Biological: CDC infusion||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||31 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Transcoronary infusion|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||A Randomized Phase 1 Trial of Cardiac Progenitor Cell Therapy in Children With Dilated Cardiomyopathy|
|Actual Study Start Date :||April 14, 2017|
|Estimated Primary Completion Date :||March 31, 2022|
|Estimated Study Completion Date :||March 31, 2023|
Experimental: CDC infusion
CDCs infusion by coronary intervention.
Biological: CDC infusion
Injection of CDCs (0.3 million per kg of body weight).
No Intervention: Observation (Control group)
Coronary angiogram without placebo infusion.
- Number of Participants with Major Cardiac Adverse Events Related to Transcoronary Infusion of CDCs. [ Time Frame: 6 months after CDC treatment ]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.
- Change in Ejection Fraction [ Time Frame: 6 months after protocol treatment ]To determine the changes in cardiac function by ejection fraction with cardiac MRI evaluation in CDC-treated participants compared with controls from baseline to 6 months of follow up.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03129568
|Contact: Hidemasa Oh, M.D., Ph.D.||+firstname.lastname@example.org|
|Contact: Shinichi Ohtsuki, M.D., Ph.D.||+email@example.com|
|Okayama University Hospital||Recruiting|
|Okayama, Japan, 700-8558|
|Contact: Hidemasa Oh, M.D., Ph.D. +81-086-235-6506 firstname.lastname@example.org|
|Contact: Shinichi Ohtsuki, M.D., Ph.D. +81-086-235-7250 email@example.com|
|Principal Investigator: Hidemasa Oh, M.D., Ph.D.|
|Study Chair:||Shigeru Uemura, M.D., Ph.D.||Shonan Tobu Clinic|