Mesenchymal Stromal Cells Delivery Through Cardiopulmonary Bypass in Pediatric Cardiac Surgery

NCT04236479 Phase 1 ACTIVE_NOT_RECRUITING

The proposed study will be a prospective, open-label, single-center, safety and feasibility phase 1 trial of allogeneic bone marrow-derived mesenchymal stromal cell (BM-MSC) delivery though 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

Details

Lead sponsor	Catherine Bollard
Phase	Phase 1
Status	ACTIVE_NOT_RECRUITING
Enrolment	17
Start date	2020-07-29
Completion	2026-09

Conditions

• Congenital Heart Disease (CHD)

Interventions

• BM-MSC

Primary outcomes

• Number of subjects who experience serious adverse events, adverse events, and/or early treatment discontinuations. — 45 days following the MSC administration
  Dose Limiting Toxicity is attributable to the MSC administration.

Countries

United States