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Stem Cell Therapy
Stem Cell Therapy for Single Ventricle Heart Conditions
Phase 1 & 2
Waitlist Available
Led By Sitaram M Emani, MD
Research Sponsored by Boston Children's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24 months
Awards & highlights
Study Summary
This trial is testing whether injecting mesenchymal precursor cells into the left ventricle of patients with hypoplastic left heart syndrome, unbalanced atrioventricular canal, or borderline left heart during their left ventricle recruitment or bidirectional Glenn procedure will improve the chances of those patients being converted to biventricular circulation.
Who is the study for?
This trial is for children under 5 with heart conditions like hypoplastic left heart syndrome, undergoing specific heart procedures. It's not for kids who've had myocardial tumors, certain valve issues, severe arrhythmias, allergies to DMSO or animal products, previous stem cell therapy for the heart, or recent other cell therapies.Check my eligibility
What is being tested?
The study tests if injecting mesenchymal precursor cells (MPCs) into the left ventricle during surgery can help convert single-ventricle hearts to two-chamber hearts. Kids will be randomly assigned to get MPCs or just standard care without MPCs during their procedure.See study design
What are the potential side effects?
Potential side effects are not detailed in this summary but may include reactions related to stem cell therapy such as immune responses or complications at the injection site.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Safety- Absence of PRA status change or local inflammation
Safety- Incidence of severe adverse events
Secondary outcome measures
Efficacy- improvement of LV end diastolic pressure
Efficacy- improvement of LV mass/volume ratio
Efficacy- rate of biventricular conversion
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Treatment ArmExperimental Treatment1 Intervention
Those randomized to the treatment arm will receive MPCs injected directly into the LV endocardium following clinical surgical maneuvers to recruit the LV (mitral valve repair, aortic valve repair, and/or resection of endocardial fibroelastosis) or BDG.
MPCs will be delivered directly into the LV endocardium via a 23-25 gauge needle following completion of all surgical procedures. A total dose of 20 million cells will be delivered, divided evenly into ~11 injections of 50 µL each. The total volume is not to exceed 2.0 mL.
Group II: Control ArmActive Control1 Intervention
Those subjects randomized to the control arm will receive standard LV recruitment or BDG with no injection.
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Who is running the clinical trial?
Boston Children's HospitalLead Sponsor
761 Previous Clinical Trials
5,579,711 Total Patients Enrolled
2 Trials studying Hypoplastic Left Heart Syndrome
240 Patients Enrolled for Hypoplastic Left Heart Syndrome
Sitaram M Emani, MDPrincipal InvestigatorBoston Children's Hospital
1 Previous Clinical Trials
16 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You are allergic to dimethyl sulfoxide (DMSO).You have or had tumors in your heart.You have a condition called aortic or mitral atresia.You have a history of serious heart rhythm problems.You have received stem cell therapy for heart repair in the past.People who have had specific heart surgeries and procedures may be included in the study.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment Arm
- Group 2: Control Arm
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 any opportunities for patients to partake in this research currently?
"The information on clinicialtrials.gov confirms that recruitment for this trial has ended; the initial post was made in November 2017 and the last edit happened in January 2022. Despite no longer recruiting subjects, 25 other clinical trials are still taking enrolment applications at this time."
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