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Stem Cell Therapy

Stem Cell Therapy for Congenital Heart Disease

Phase 1
Waitlist Available
Led By Benjamin Peeler, MD
Research Sponsored by Timothy J Nelson, MD, PhD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of a congenital heart defect with functionally single right ventricle (such as HLHS, HLHS variants, unbalanced AV septal defect with R dominance, DORV with Hypoplastic LV) undergoing Fontan surgical palliation
At least 2 and less than or equal to 5 years of age at time of Fontan surgical palliation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up within 3 months post fontan surgery
Awards & highlights

Study Summary

This trial will test whether injecting stem cells into the heart during surgery can improve heart function.

Who is the study for?
This trial is for children aged 2-5 with a specific heart defect (like HLHS) who are undergoing Fontan surgery. They must have previously participated in a related clinical trial and have their own stem cells available. Kids can't join if they've had severe reactions to certain preservatives, other serious chronic diseases, cancer, recent urgent procedures, or conditions that could worsen their outcome.Check my eligibility
What is being tested?
The study tests the effects of injecting autologous mononuclear cells directly into the heart muscle during Fontan surgery on kids with single right ventricle defects. It aims to see if this treatment improves heart structure and function compared to those not receiving stem cells.See study design
What are the potential side effects?
Potential side effects aren't specified but may include typical risks associated with stem cell injections such as immune reactions or complications at the injection site. The procedure's impact will be closely monitored against any adverse changes in cardiac function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have a single functioning right ventricle and am undergoing Fontan surgery.
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I had the Fontan surgery between 2 and 5 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~within 3 months post fontan surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and within 3 months post fontan surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Short-term safety
Secondary outcome measures
Cumulative days hospitalization
High sensitivity Troponin T
Long term safety
+5 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Treatment ArmExperimental Treatment1 Intervention
Autologous (self) mononuclear cells derived from umbilical cord blood and that meet all release criteria are injected into the surface of the right heart muscle to achieve the target dose of 3 million cells per kilogram of body weight. This is a one time treatment at the time of Stage III Fontan surgery.
Group II: Control ArmActive Control1 Intervention
Control cohort not receiving the cell product, which will be enrolled and followed using the same inclusion/exclusion criteria and follow-up requirements as the treatment arm.

Find a Location

Who is running the clinical trial?

Children's of AlabamaOTHER
8 Previous Clinical Trials
2,945 Total Patients Enrolled
University of OklahomaOTHER
455 Previous Clinical Trials
97,580 Total Patients Enrolled
Children's Hospital of PhiladelphiaOTHER
708 Previous Clinical Trials
8,581,273 Total Patients Enrolled

Media Library

Autologous Mononuclear Cells (Stem Cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04907526 — Phase 1
Congenital Heart Disease Research Study Groups: Treatment Arm, Control Arm
Congenital Heart Disease Clinical Trial 2023: Autologous Mononuclear Cells Highlights & Side Effects. Trial Name: NCT04907526 — Phase 1
Autologous Mononuclear Cells (Stem Cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04907526 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is Autologous mononuclear cells considered a secure treatment option?

"Due to its Phase 1 status, which suggests limited evidence of safety and efficacy, the Autologous mononuclear cells received a score of 1 on our scale."

Answered by AI

Do I fulfill the criteria for participating in this research endeavor?

"This medical trial is seeking 30 participants with congenital heart disease, who are dependent on SRV and aged between 2 and 5."

Answered by AI

Are there any restrictions on the number of participants who can join this clinical investigation?

"In order to successfully conduct this trial, 30 eligible patients need to take part. These individuals may come from various sites such as Children's Hospital Colorado in Aurora or Children's Hospital Los Angeles in California."

Answered by AI

Are there any openings in this research study for new participants?

"Affirmative. On clinicaltrials.gov, this research is documented as actively seeking participants since its first posting on June 1st 2021 and subsequent edits until April 28th 2022. There are a total of 5 sites enrolling 30 individuals in the study."

Answered by AI

What are the available venues for this clinical investigation?

"This research is taking place at 5 clinical centres located in Aurora, Los Angeles and Rochester as well as two other cities. To reduce the amount of necessary travel for those participating in this study, it wise to pick a site nearest you."

Answered by AI

Does this clinical trial impose an age restriction, and if so, what is the cutoff?

"Eligible patients for this trial must be aged between 2 and 5 years old."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Intramyocardial Injection of Autologous UCB-MNC During Fontan Surgery for SRV Dependent CHD
Timothy J Nelson, MD, PhD 2021. "Intramyocardial Injection of Autologous UCB-MNC During Fontan Surgery for SRV Dependent CHD". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04907526.
~8 spots leftby Apr 2025
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