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Mesenchymal Stromal Cells

Mesenchymal Stromal Cells for Congenital Heart Disease

Phase 1

Waitlist Available

Led By Richard Jonas, MD

Research Sponsored by Catherine Bollard

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Scheduled to undergo reparative two-ventricle repair for congenital heart defects without aortic arch reconstruction

Neonatal and young infantile patients who are ≤ 3 months of age

Must not have

Birth weight less than 2.0 kg

Previous cardiac surgery

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 18 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will test whether it is safe to give infants with congenital heart disease BM-MSC cells through cardiopulmonary bypass, and whether this is a feasible method of delivery.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

As this is an early phase trial focusing on safety and feasibility, specific side effects of BM-MSC delivery through CPB are not detailed but may include typical risks associated with cell therapies such as immune reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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My child is 3 months old or younger.

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My parent or guardian can legally agree to my participation.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My birth weight was under 2.0 kg.

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I have had heart surgery before.

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I needed heart surgery as a baby for heart and large blood vessel issues.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 18 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~18 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 18 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of subjects who experience serious adverse events, adverse events, and/or early treatment discontinuations.

Secondary study objectives

Actual magnitude of differences in neuroimaging and neurodevelopmental variables will be measured after MSC delivery.

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

BM-MSC

2012

Completed Phase 1

~20

0 / 6Eligibility criteria met