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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18 months
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I am scheduled for a heart surgery to fix defects without needing to repair the aortic arch.
Select...
My child is 3 months old or younger.
Select...
My parent or guardian can legally agree to my participation.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 18 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of subjects who experience serious adverse events, adverse events, and/or early treatment discontinuations.
Secondary outcome measures
Actual magnitude of differences in neuroimaging and neurodevelopmental variables will be measured after MSC delivery.
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
Find a Location
Who is running the clinical trial?
Catherine BollardLead Sponsor
13 Previous Clinical Trials
314 Total Patients Enrolled
Richard Jonas, MDPrincipal InvestigatorCNMC
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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.I am scheduled for a heart surgery to fix defects without needing to repair the aortic arch.I have had heart surgery before.My child is 3 months old or younger.I have a condition that affects my appearance or physical development.I needed heart surgery as a baby for heart and large blood vessel issues.You have serious non-heart related birth defects.My parent or guardian can legally agree to my participation.
Research Study Groups:
This trial has the following groups:- Group 1: Bone marrow-derived mesenchymal stromal cell (BM-MSC)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there opportunities for enrolment in this trial currently?
"The current information on clinicaltrials.gov reveals that the trial is open for recruitment, with initial posting of July 29th 2020 and most recent update occurring May 11th 2022."
Answered by AI
To what extent is this clinical trial being populated by participants?
"Indeed, the details on clinicaltrials.gov reveal that this experiment is presently looking for participants. It was originally posted on July 29th 2020 and most recently revised May 11th 2022. The research team seeks to recruit 36 subjects from a single medical centre."
Answered by AI
To what extent would administering BM-MSC to patients be considered risk-free?
"As a Phase 1 trial, the level of clinical data to support BM-MSC's safety and efficacy is limited, consequently receiving a score of 1 from our team at Power."
Answered by AI
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