Mesenchymal Stromal Cells for Infants With Congenital Heart Disease (MedCaP)
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|ClinicalTrials.gov Identifier: NCT04236479|
Recruitment Status : Recruiting
First Posted : January 22, 2020
Last Update Posted : April 5, 2021
|Condition or disease||Intervention/treatment||Phase|
|Congenital Heart Disease (CHD)||Biological: BM-MSC||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||36 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Mesenchymal Stromal Cells Delivery Through Cardiopulmonary Bypass in Pediatric Cardiac Surgery|
|Actual Study Start Date :||July 29, 2020|
|Estimated Primary Completion Date :||April 2022|
|Estimated Study Completion Date :||April 2023|
Experimental: Bone marrow-derived mesenchymal stromal cell (BM-MSC)
The dose-escalation methods with a modified continual reassessment at the five dose levels (1x10^6, 10x10^6, 20x10^6, 40x10^6, 80x10^6 cells/kg) will be performed to determine safety and feasibility of allogeneic BM-MSC infusion during pediatric cardiac surgery and the maximum tolerated dose in infants with CHD.
Allogeneic bone marrow-derived mesenchymal stromal cell (BM-MSC) delivery through cardiopulmonary bypass (CPB) using a homogeneous population of infants with congenital heart disease (CHD) who will be undergoing a two-ventricle repair within the first six months of life.
- Number of subjects who experience serious adverse events, adverse events, and/or early treatment discontinuations. [ Time Frame: 45 days following the MSC administration ]Dose Limiting Toxicity is attributable to the MSC administration.
- Actual magnitude of differences in neuroimaging and neurodevelopmental variables will be measured after MSC delivery. [ Time Frame: 18 months ]Secondary objective will be measured by using the Pediatric Cardiac Critical Care Consortium (PC4) registry system.
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): NCT04236479
|Contact: Nobuyuki Ishibashi, MD||202-476-2388||NIshibas@childrensnational.org|
|Contact: Fahmida Hoq, MBBS, MSfirstname.lastname@example.org|
|United States, District of Columbia|
|Children's National Health System||Recruiting|
|Washington, District of Columbia, United States, 20010|
|Contact: Nobuyuki Ishibashi,, MD 202-476-2388 NIshibas@childrensnational.org|
|Principal Investigator: Richard Jonas, MD|
|Principal Investigator:||Richard Jonas, MD||CNMC|