Hypoplastic Left Heart SyndromePhase 2NCT03779711

Intramyocardial Injection of Autologous Umbilical Cord Blood Derived Mononuclear Cells During Surgical Repair of Hypoplastic Left Heart Syndrome

A Phase 2 study testing Autologous (self) mononuclear cells derived from umbilical cord blood and Stage II Surgical repair in people with Hypoplastic Left Heart Syndrome, run by Timothy J Nelson, MD, PhD at 8 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

Who is it for?: Ages Up to 12 months
Conditions the study is for: Hypoplastic Left Heart Syndrome
What is being tested?: Autologous (self) mononuclear cells derived from umbilical cord blood and Stage II Surgical repair
Type of treatment: Injection or infusion, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 95 participants
Where: 8 sitesUnited States
Study dates: 6 Jun 2019to Feb 2026
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Up to 12 months
All sexes
No healthy volunteers
Child

Who may be able to join

Diagnosis of HLHS or HLHS variant with single right ventricular dependent CHD having undergone Stage I surgical repair and undergoing Stage II surgical repair.
Less than 13 months of age at time of Stage II surgical repair
Previous participation in the UCB collection protocol with autologous UCB-MNC product that is acceptable for use (treatment arm only)

Who cannot join

History of DMSO reaction (treatment arm only).
Parent(s) and/or legal guardian(s) unwilling to have their child participate or unwilling to follow the study procedures.
Severe chronic diseases at the discretion of the treating physician.
Extensive extra-cardiac syndromic features.
Known history of cancer.
Any of the following complications of his/her congenital heart disease:

Show all 9Show fewer

Any condition requiring urgent, or unplanned interventional procedure within 15 days prior to Stage II surgical repair, unless complete and full cardiac recovery is documented by site investigator
Severe pulmonary hypertension (reported in the medical record as >70% systemic pressure)
Other clinical concerns as documented by a site investigator that would predict (more likely to happen than not to happen) a risk of severe complications or very poor outcome, not directly related to the stem cell product or its injection procedure, during or after Stage II surgical repair.

Trial locations and contacts

8 sites in 1 country.

City, postcode or hospital

8 sites in 1 country

United States8 sites

Children's Hospital Colorado
Aurora, Colorado, 80045
Children's of Alabama
Birmingham, Alabama, 35233
Cincinnati Children's Hospital and Medical Center
Cincinnati, Ohio, 45529
Children's Hospital of Los Angeles
Los Angeles, California, 90027
Children's Hospitals of Minnesota
Minneapolis, Minnesota, 55404
Ocshner Medical Center
New Orleans, Louisiana, 70121
Oklahoma University Medical Center
Oklahoma City, Oklahoma, 73104
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

Official title: Phase IIb Study of Intramyocardial Injection of Autologous Umbilical Cord Blood Derived Mononuclear Cells During Stage II Surgical Repair of Right Ventricular Dependent Variants of Hypoplastic Left Heart Syndrome (AutoCell-S2)

Researchers want to better understand what happens to the heart when the stem cells are injected directly into the muscle of the right side of the heart during the Stage II palliative surgery for single ventricle patients with hypoplastic left heart syndrome (HLHS) or HLHS variant. 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.

Read the detailed description

This is a Phase IIb trial to determine if the delivery of the autologous UCB-MNC product into the myocardium of the right ventricle of the heart at the time of Stage II surgical repair will provide an improvement in cardiac function, reaching growth and developmental milestones, and quality of life, while also providing a reduction in the cumulative days of hospitalization following Stage II surgical repair. Long-term improvement in cardiac function, reaching growth and developmental milestones, reaching Stage III surgical repair pre-op work-up, prolonging time to cardiac transplantation or death, and improving quality of life will also be determined.

Conditions: Hypoplastic Left Heart Syndrome
Being tested: Autologous (self) mononuclear cells derived from umbilical cord blood, Stage II Surgical repair
Keywords: Hypoplastic Left Heart Syndrome, HLHS, Congenital Heart Disease, Umbilical Cord Blood, UCB, Cord blood, Stem cells, Regenerative therapy, Stage II Glenn, Glenn Surgery, single ventricle
Medical subject headings: Hypoplastic Left Heart Syndrome, Heart Defects, Congenital, Univentricular Heart

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Autologous (self) mononuclear cells derived from umbilical cord bloodBiological
The investigational product will be delivered into the right myocardium via sub-epicardial injections of 0.1 mL per kg body weight to achieve the target dose of 1-3 million TNC per kg body weight.at the time of Stage II surgical repair.
Stage II Surgical repairProcedure or surgery
This operation usually is performed about six months after Stage I surgery to divert half of the blood to the lungs when circulation through the lungs no longer needs as much pressure from the ventricle. The shunt to the pulmonary arteries is disconnected and the right pulmonary artery is connected directly to the superior vena cava, the vein that brings deoxygenated blood from the upper part of the body to the heart. This sends half of the deoxygenated blood directly to the lungs without going through the ventricle.

Study groups in NCT03779711
Study group	Role	What they receive
Treatment	Experimental	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 . Receives: Biological: Autologous (self) mononuclear cells derived from umbilical cord blood; Procedure: Stage II Surgical repair
Control	Active comparator	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. Receives: Procedure: Stage II Surgical repair

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in Right Ventricular Cardiac Function Measured by Apical Fractional Area Change (FAC)
Right ventricular cardiac function as measured by echocardiogram that includes studies for apical fractional area change (FAC). Measured by percent.
Measured: baseline, 3 months post-Stage II surgery
Change in Right Ventricular Cardiac Function Measured by Circumferential Strain.
Right ventricular cardiac function as measured by echocardiogram that includes studies for circumferential strain. Measured by percent.
Measured: baseline, 3 months post-Stage II surgery
Change in Right Ventricular Cardiac Function Measured by Longitudinal Strain.
Right ventricular cardiac function as measured by echocardiogram that includes studies for longitudinal strain. Measured by percent.
Measured: baseline, 3 months post-Stage II surgery
Change in Right Ventricular Cardiac Function Measured by Apical Fractional Area Change (FAC)
Right ventricular cardiac function as measured by echocardiogram that includes studies for apical fractional area change (FAC). Measured by percent.
Measured: baseline, 12 months post-Stage II surgery

Secondary outcomes (12)

Change in Right Ventricular Cardiac Function Measured by Apical Fractional Area Change (FAC)
Right ventricular cardiac function as measured by echocardiogram that includes studies for apical fractional area change (FAC). Measured by percent.
Measured: baseline pre-op, hospital discharge from Stage II surgery (an average of 1-6 weeks)
Cumulative Days of Hospitalization
Cumulative days of hospitalization per patient following discharge for the Stage II surgical repair.
Measured: 1-month post Stage II surgery
Change in Weight
Change in weight between baseline and 3-months post Stage II surgery. Weight as measured by scale provided as part of standard of care by subject's provider. Measured at home by subject's caregiver using the same scale for every home measurement of body weight. Caregivers will be instructed by the site to use the same scale for every home measurement of body weight. Scales will vary based on the institution's standard name/type used.
Measured: baseline, 3-months post Stage II surgery
Change in Heart Rate
Change in heart rate between baseline and 3-months post Stage II surgery. Heart rate as measured at home by subject's caregiver as standard of care per subject's provider. Caregivers will be instructed by the site staff on the best way to perform.
Measured: baseline, 3-months post Stage II surgery
Change in Oxygen Saturation
Change in oxygen saturation between baseline and 3-months post Stage II surgery. Oxygen saturation as measured at home by subject's caregiver using the pulse oximetry device provided as standard of care by subject's provider. Caregivers will be instructed by the site to use the same pulse oximetry device for every home measurement of oxygen saturation.
Measured: baseline, 3-months post Stage II surgery
Change in Weight
Weight as measured by scale provided as part of standard of care by subject's provider. Measured at home by subject's caregiver using the same scale for every home measurement of body weight. Caregivers will be instructed by the site to use the same scale for every home measurement of body weight. Scales will vary based on the institution's standard name/type used.
Measured: baseline, every 6 months post-Stage II surgery
Change in Arrhythmia and Heart Failure Medication
Changes in arrhythmia and heart failure medications will be recorded by caregiver on the concomitant medication diary throughout the subject's participation in the study starting at the time of consent.
Measured: 3-months post-surgery
Stage III Surgical Repair
The number of research subjects eligible for Stage III surgical repair
Measured: Stage III surgery pre-op, approx. 4 years
Total Time Until Listed for Cardiac Transplantation
The number of days between Stage II surgery and listed on cardiac transplantation list.
Measured: up to Stage III surgery pre-op, approx. 4 years
Change in Right Ventricular Cardiac Function Measured by Apical Fractional Area Change (FAC)
Right ventricular cardiac function as measured by echocardiogram that includes studies for apical fractional area change (FAC). Measured by percent.
Measured: baseline, Stage III surgery pre-op
Total Time Until Death
The number of days between Stage II surgery and death occurrence
Measured: approx 4 years
Cumulative Days of Hospitalization
Cumulative days of hospitalization per patient following discharge for the Stage II surgical repair.
Measured: 3-months post Stage II surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Jun 2019Feb 2026

First posted19 Dec 2018
Study start6 Jun 2019
Primary completion22 May 2022
Study completionFeb 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Hypoplastic Left Heart SyndromeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 95 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03779711
Sponsor's protocol ID: 18-004753
Status last verified: Jun 2025
First submitted: 4 Dec 2018
Last updated: 8 Jul 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Gallego-Navarro C, Jaggers J, Burkhart HM, Carlo WF, Morales DL, Qureshi MY, Rossano JW, Hagen CE, Seisler DK, Peral SC, Nelson TJ. Autologous umbilical cord blood mononuclear cell therapy for hypoplastic left heart syndrome: a nonrandomized control trial of the efficacy and safety of intramyocardial injections. Stem Cell Res Ther. 2025 May 1;16(1):215. doi: 10.1186/s13287-025-04316-3.
PubMed 40312733

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingObservational study
Long-term Safety Study Following to JRM-001 Treatment in Pediatric Patients With Congenital Heart Disease
Single Ventricle, Hypoplastic Left Heart Syndrome (HLHS)
RecruitingPhase 3
Cardiac Stem/Progenitor Cell Infusion in Univentricular Physiology (APOLLON Trial)
Hypoplastic Left Heart Syndrome, Single Ventricle
RecruitingObservational study
Prenatal Maternal Mental Health and Neurodevelopment in Congenital Heart Disease
Congenital Heart Disease, Cyanotic Congenital Heart Disease
Enrolling by invitation
Fetal Aortic Valvuloplasty for Evolving Hypoplastic Left Heart Syndrome
Hypoplastic Left Heart Syndrome
Active, not recruitingObservational study
Long-term Outcomes of Children With Hypoplastic Left Heart Syndrome and the Impact of Norwood Shunt Type
Heart Defects

All Hypoplastic Left Heart Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Phase IIb Study of Intramyocardial Injection of Autologous Umbilical Cord Blood Derived Mononuclear Cells During Stage II Surgical Repair of Right Ventricular Dependent Variants of Hypoplastic Left Heart Syndrome (AutoCell-S2)
ClinicalTrials.gov ID: NCT03779711
Acronym / sponsor ID: 18-004753
Conditions: Hypoplastic Left Heart Syndrome
Keywords: Hypoplastic Left Heart Syndrome, HLHS, Congenital Heart Disease, Umbilical Cord Blood, UCB, Cord blood, Stem cells, Regenerative therapy
Phase: Phase 2
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 95 participants (actual)
Lead sponsor: Timothy J Nelson, MD, PhDUniversity, hospital or other
Collaborators: University of Oklahoma, Children's Hospital of Philadelphia, Children's Hospital Los Angeles, Children's Hospital Colorado, Children's Hospitals and Clinics of Minnesota, Ochsner Health System, Children's of Alabama, Children's Hospital Medical Center, Cincinnati
Study start: 6 Jun 2019 (actual)
Primary completion: 22 May 2022 (actual)
Study completion: Feb 2026 (estimated)
First posted: 19 Dec 2018 (actual)
Results: Posted 8 Jul 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Treatment	Experimental	Biological: Autologous (self) mononuclear cells derived from umbilical cord blood, Procedure: Stage II Surgical repairAutologous (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 .
Control	Active comparator	Procedure: Stage II Surgical repairClinical 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.

Who may qualify

Ages: Up to 12 months
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (3 listed)

Diagnosis of HLHS or HLHS variant with single right ventricular dependent CHD having undergone Stage I surgical repair and undergoing Stage II surgical repair.
Less than 13 months of age at time of Stage II surgical repair
Previous participation in the UCB collection protocol with autologous UCB-MNC product that is acceptable for use (treatment arm only)

Key exclusion criteria (9 listed)

History of DMSO reaction (treatment arm only).
Parent(s) and/or legal guardian(s) unwilling to have their child participate or unwilling to follow the study procedures.
Severe chronic diseases at the discretion of the treating physician.
Extensive extra-cardiac syndromic features.
Known history of cancer.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Autologous (self) mononuclear cells derived from umbilical cord bloodThe investigational product will be delivered into the right myocardium via sub-epicardial injections of 0.1 mL per kg body weight to achieve the target dose of 1-3 million TNC per kg body weight.at the time of Stage II surgical repair.	Biological	Treatment
Stage II Surgical repairThis operation usually is performed about six months after Stage I surgery to divert half of the blood to the lungs when circulation through the lungs no longer needs as much pressure from the ventricle. The shunt to the pulmonary arteries is disconnected and the right pulmonary artery is connected directly to the superior vena cava, the vein that brings deoxygenated blood from the upper part of the body to the heart. This sends half of the deoxygenated blood directly to the lungs without going through the ventricle.	Procedure or surgery	Control, Treatment

Primary outcome

Change in Right Ventricular Cardiac Function Measured by Apical Fractional Area Change (FAC)
Time frame: baseline, 3 months post-Stage II surgery
Right ventricular cardiac function as measured by echocardiogram that includes studies for apical fractional area change (FAC). Measured by percent.
Change in Right Ventricular Cardiac Function Measured by Circumferential Strain.
Time frame: baseline, 3 months post-Stage II surgery
Right ventricular cardiac function as measured by echocardiogram that includes studies for circumferential strain. Measured by percent.
Change in Right Ventricular Cardiac Function Measured by Longitudinal Strain.
Time frame: baseline, 3 months post-Stage II surgery
Right ventricular cardiac function as measured by echocardiogram that includes studies for longitudinal strain. Measured by percent.
Change in Right Ventricular Cardiac Function Measured by Apical Fractional Area Change (FAC)
Time frame: baseline, 12 months post-Stage II surgery
Right ventricular cardiac function as measured by echocardiogram that includes studies for apical fractional area change (FAC). Measured by percent.

12 secondary outcomes

Change in Right Ventricular Cardiac Function Measured by Apical Fractional Area Change (FAC)
Time frame: baseline pre-op, hospital discharge from Stage II surgery (an average of 1-6 weeks)
Cumulative Days of Hospitalization
Time frame: 1-month post Stage II surgery
Change in Weight
Time frame: baseline, 3-months post Stage II surgery
Change in Heart Rate
Time frame: baseline, 3-months post Stage II surgery
Change in Oxygen Saturation
Time frame: baseline, 3-months post Stage II surgery
Change in Weight
Time frame: baseline, every 6 months post-Stage II surgery
Change in Arrhythmia and Heart Failure Medication
Time frame: 3-months post-surgery
Stage III Surgical Repair
Time frame: Stage III surgery pre-op, approx. 4 years
Total Time Until Listed for Cardiac Transplantation
Time frame: up to Stage III surgery pre-op, approx. 4 years
Change in Right Ventricular Cardiac Function Measured by Apical Fractional Area Change (FAC)
Time frame: baseline, Stage III surgery pre-op
Total Time Until Death
Time frame: approx 4 years
Cumulative Days of Hospitalization
Time frame: 3-months post Stage II surgery

Results and safety

Results posted to the registry on 8 Jul 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment	50	40
Control	45	41

Primary outcome: Change in Right Ventricular Cardiac Function Measured by Apical Fractional Area Change (FAC)

Time frame: baseline, 3 months post-Stage II surgery. Least squares mean (95% Confidence Interval). Unit: percentage of area

Measure	Treatment n = 40	Control n = 41
Value	-2.2258 (-3.8988 to -0.5527)	-2.5116 (-4.1641 to -0.8590)

Treatment vs Control: p = 0.8095, ANCOVA

Population analysed: All enrolled subjects with both a baseline and 3-month Fractional Area Change value as assessed by Echocardiogram.

Primary outcome: Change in Right Ventricular Cardiac Function Measured by Circumferential Strain.

Time frame: baseline, 3 months post-Stage II surgery. Least squares mean (95% Confidence Interval). Unit: percentage of area

Measure	Treatment n = 30	Control n = 35
Value	1.3412 (-0.3101 to 2.9925)	0.1704 (-1.3582 to 1.6990)

Treatment vs Control: p = 0.3029, ANCOVA

Population analysed: All enrolled subjects with both baseline and 3-month circumferential strain values as assessed by echocardiogram.

Primary outcome: Change in Right Ventricular Cardiac Function Measured by Longitudinal Strain.

Time frame: baseline, 3 months post-Stage II surgery. Least squares mean (95% Confidence Interval). Unit: percentage of area

Measure	Treatment n = 39	Control n = 39
Value	0.5394 (-.06073 to 1.6860)	-1.2407 (-2.3873 to -0.09402)

Treatment vs Control: p = 0.0323, ANCOVA

Population analysed: All enrolled subjects with both baseline and 3-month longitudinal strain values as assessed by echocardiogram.

Primary outcome: Change in Right Ventricular Cardiac Function Measured by Apical Fractional Area Change (FAC)

Time frame: baseline, 12 months post-Stage II surgery. Least squares mean (95% Confidence Interval). Unit: percentage of area

Measure	Treatment n = 33	Control n = 32
Value	-3.8975 (-5.6808 to -2.1143)	-4.4310 (-6.2419 to -2.6201)

Treatment vs Control: p = 0.6765, ANCOVA

Population analysed: All enrolled subjects with both baseline and 12-month fractional area changes values, as assessed by echocardiogram.

12 secondary outcomes are reported in the full results.

Adverse events

Time frame: 4 years. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment	38 of 50 (76%)	48 of 50 (96%)	4 of 50
Control	27 of 45 (60%)	45 of 45 (100%)	3 of 45

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 40312733Gallego-Navarro C, Jaggers J, Burkhart HM, Carlo WF, Morales DL, Qureshi MY, Rossano JW, Hagen CE, Seisler DK, Peral SC, Nelson TJ. Autologous umbilical cord blood mononuclear cell therapy for hypoplastic left heart syndrome: a nonrandomized control trial of the efficacy and safety of intramyocardial injections. Stem Cell Res Ther. 2025 May 1;16(1):215. doi: 10.1186/s13287-025-04316-3.
Mayo Clinic Clinical TrialsLink provided by the sponsor.
Individual participant dataSharing planned: No

Related trials for Hypoplastic Left Heart Syndrome

RecruitingObservational study
Long-term Safety Study Following to JRM-001 Treatment in Pediatric Patients With Congenital Heart Disease
Single Ventricle, Hypoplastic Left Heart Syndrome (HLHS)
RecruitingPhase 3
Cardiac Stem/Progenitor Cell Infusion in Univentricular Physiology (APOLLON Trial)
Hypoplastic Left Heart Syndrome, Single Ventricle
RecruitingObservational study
Prenatal Maternal Mental Health and Neurodevelopment in Congenital Heart Disease
Congenital Heart Disease, Cyanotic Congenital Heart Disease
Enrolling by invitation
Fetal Aortic Valvuloplasty for Evolving Hypoplastic Left Heart Syndrome
Hypoplastic Left Heart Syndrome
Active, not recruitingObservational study
Long-term Outcomes of Children With Hypoplastic Left Heart Syndrome and the Impact of Norwood Shunt Type
Heart Defects

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Frank Cetta, MD principal investigator

Mayo Clinic

Harold M. Burkhart, M.D. principal investigator

Children's Hospital Oklahoma University Medical Center

Joseph W. Rossano, M.D. principal investigator

Children's Hospital of Philadelphia

8 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 8 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Right Ventricular Cardiac Function Measured by Apical Fractional Area Change (FAC) (time frame: baseline, 3 months post-Stage II surgery). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03779711, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2025.