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Stem Cell Therapy for Hypoplastic Left Heart Syndrome
Phase 2
Waitlist Available
Led By James Tweddell, M.D.
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
Less than 13 months of age at time of Stage II surgical repair
Diagnosis of HLHS or HLHS variant with single right ventricular dependent CHD having undergone Stage I surgical repair and undergoing Stage II surgical repair.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approx 4 years
Awards & highlights
Study Summary
This trial is testing a stem cell treatment for children with HLHS. Researchers want to see if there are changes in the heart's structure/function following this stem cell-based therapy and compared to children that have not had cell-based therapy.
Who is the study for?
This trial is for children under 13 months old with Hypoplastic Left Heart Syndrome or a similar condition, who've had Stage I surgery and are set for Stage II. They must have their own umbilical cord blood cells available for treatment. Kids with severe chronic diseases, pulmonary hypertension, recent urgent procedures without recovery, cancer history, or syndromic features can't participate.Check my eligibility
What is being tested?
The study tests injecting autologous (self-donated) mononuclear cells from umbilical cord blood into the heart muscle during Stage II surgery in kids with certain heart conditions. It aims to see if this stem cell therapy improves heart structure/function compared to those without such treatment.See study design
What are the potential side effects?
Potential side effects aren't specified but may include reactions related to the injection procedure or the body's response to its own cells being reintroduced. Close monitoring will occur due to the experimental nature of this therapy.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I was younger than 13 months when I had my Stage II surgery.
Select...
I have HLHS or a similar condition and am between my first and second heart surgeries.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ approx 4 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approx 4 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Right Ventricular Cardiac Function measured by apical fractional area change (FAC)
Change in Right Ventricular Cardiac Function measured by circumferential strain.
Heart Function Tests
+1 moreSecondary outcome measures
Change in arrhythmia medication
Change in ejection fraction
Change in heart failure medication
+8 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: TreatmentExperimental Treatment2 Interventions
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 1-3 million cells per kilogram body weight . This is a one time treatment at the time of Stage II Glenn surgery .
Group II: ControlActive Control1 Intervention
Clinical data will be collected before, during and after the Stage II surgical standard of care procedure. Requires additional imaging studies at 3 months that are not standard of care in addition to some blood tests that would be beyond standard of care. Information will be collected to document the clinical outcomes and will be compared with the information from the group receiving the investigational treatment used in this study.
Find a Location
Who is running the clinical trial?
Timothy J Nelson, MD, PhDLead Sponsor
4 Previous Clinical Trials
74 Total Patients Enrolled
2 Trials studying Hypoplastic Left Heart Syndrome
34 Patients Enrolled for Hypoplastic Left Heart Syndrome
University of OklahomaOTHER
455 Previous Clinical Trials
97,515 Total Patients Enrolled
2 Trials studying Hypoplastic Left Heart Syndrome
34 Patients Enrolled for Hypoplastic Left Heart Syndrome
Children's Hospital of PhiladelphiaOTHER
708 Previous Clinical Trials
8,581,180 Total Patients Enrolled
5 Trials studying Hypoplastic Left Heart Syndrome
394 Patients Enrolled for Hypoplastic Left Heart Syndrome
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have previously participated in a UCB collection protocol and used your own UCB-MNC product for treatment.I have a history of cancer.My medical records show I have severe pulmonary hypertension.I was younger than 13 months when I had my Stage II surgery.You have other symptoms outside of the heart that are part of a specific condition.Your doctor has documented other health issues that make it likely for you to have severe complications or a very poor outcome during or after the surgical repair, which are not directly related to the stem cell treatment or its injection.I have HLHS or a similar condition and am between my first and second heart surgeries.I haven't had any emergency procedures in the last 15 days, or if I did, I am fully recovered.You have had a reaction to DMSO in the past.You have a serious long-term illness, as determined by your doctor.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment
- Group 2: Control
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.
Where are the sites offering this trial located in this state?
"This clinical research is being conducted in Oklahoma University Medical Center, located in Oklahoma City, Children's Hospital of Los Angeles and Children's Hospital Colorado situated in Aurora. Additionally, 8 other medical sites are included as part of the trial."
Answered by AI
What goals are the researchers hoping to accomplish with this trial?
"The central goal of this research project, to be assessed at the baseline and 3 months post-Stage II surgery, is an alteration in Right Ventricular Cardiac Function as evaluated by apical fractional area change (FAC). Other secondary objectives include fluctuations in heart failure medication mentioned on a concomitant medication diary from consent onwards; total time until death between Stage II surgery and passing away; and changes in oxygen saturation measured by pulse oximetry device for home assessments."
Answered by AI
Is Stage II Surgical repair a viable option with minimal risks for individuals?
"The safety of Stage II Surgical repair scored a 2 because there is limited clinical data available to support its effectiveness, though some evidence has been found in regards to the treatment's security."
Answered by AI
Is there an ongoing recruitment process for participants in this experiment?
"As per the records on clinicaltrials.gov, recruitment for this particular trial has been suspended since April 28th 2022. Despite that, there are still 1393 other trials actively looking to bring in new participants."
Answered by AI
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