Mesenchymal Stromal Cells for Congenital Heart Disease

Recruiting in Palo Alto (17 mi)

Overseen byRichard Jonas, MD

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Catherine Bollard

No Placebo Group

Trial Summary

What is the purpose of this trial?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

Eligibility Criteria

This trial is for infants ≤ 3 months old with congenital heart disease needing a two-ventricle repair but no aortic arch reconstruction. Parents must consent. Infants under 2 kg, with syndromes, severe extracardiac anomalies, prior heart surgery or hypoxic events, or at risk from study participation are excluded.

Inclusion Criteria

I am scheduled for a heart surgery to fix defects without needing to repair the aortic arch.

My child is 3 months old or younger.

My parent or guardian can legally agree to my participation.

Exclusion Criteria

Your test results show that you may have a higher chance of having problems if you join the study.

My birth weight was under 2.0 kg.

You have had a serious lack of oxygen in the past.

+4 more

Participant Groups

The MedCaP trial tests the safety and feasibility of delivering allogeneic bone marrow-derived mesenchymal stromal cells (BM-MSC) to infants with CHD during cardiopulmonary bypass in their first six months.

1Treatment groups

Experimental Treatment

Group I: Bone marrow-derived mesenchymal stromal cell (BM-MSC)Experimental Treatment1 Intervention

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.