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Evaluation of Lomecel-B™ Injection in Patients With Hypoplastic Left Heart Syndrome: A Phase IIb Clinical Trial. (ELPISII)

Primary Purpose

Hypoplastic Left Heart Syndrome

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Lomecel-B medicinal signaling cells
Sponsored by
Ann & Robert H Lurie Children's Hospital of Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypoplastic Left Heart Syndrome focused on measuring Hypoplastic Left Heart Syndrome, Pediatrics, Heart Defects, Congenital Cardiovascular Diseases, Stem Cells

Eligibility Criteria

undefined - 12 Months (Child)All SexesDoes not accept healthy volunteers

Inclusion:

All participants must have HLHS (includes all types) requiring Stage II palliation (Glenn or Hemi-Fontan operation).

Exclusion:

  1. Requirement for ongoing mechanical circulatory support immediately prior to Stage II palliation within 5 days
  2. Need for concomitant surgery for aortic coarctation or tricuspid valve repair or Endocardial fibroelastosis (EFE) resection or left ventricle recruitment procedures
  3. Undergoing the Stage I (Norwood) procedure that does not have HLHS

  4. Serum positivity for: human immunodeficiency virus (HIV); hepatitis B virus surface antigen (HBV BsAg); and/or viremic hepatitis C virus (HCV). This criterion can be ascertained by one of three ways:

    1. Documented history of mother's testing conducted during pregnancy
    2. Documented history of participants testing.
    3. If above documentation is not available blood will be obtained from participant at Screening/Baseline.
  5. Parent/guardian that is unwilling or unable to comply with necessary follow-up
  6. Unsuitability for the study based on the Investigator's clinical opinion
  7. Known hypersensitivity to dimethyl sulfoxide (DMSO)
  8. Presence of a pacemaker, or anticipated placement of a pacemaker, at the time of the Stage II palliation

Sites / Locations

  • Children's Hospital of Los AngelesRecruiting
  • Children's Healthcare of AtlantaRecruiting
  • Advocate Children's HospitalRecruiting
  • Ann & Robert H. Lurie Children's Hospital of ChicagoRecruiting
  • Boston Children's HospitalRecruiting
  • Cincinnati Children's Hospital Medical CenterRecruiting
  • UTHealth-McGovern Medical SchoolRecruiting
  • Primary Children's Hospital/University of UtahRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Lomecel B Group

No Study Intervention Control Group

Arm Description

Participants randomized to receive Lomecel-B injections during their Stage II palliation.

Participants randomized to receive no study intervention during their Stage II palliation.

Outcomes

Primary Outcome Measures

Change in right ventricular ejection fraction (RVEF)
Efficacy will be reported as change in right ventricular ejection fraction (RVEF) assessed as a percentage and will be measured via cardiac magnetic resonance (CMR) imaging.

Secondary Outcome Measures

Change in right ventricular ejection fraction (RVEF)
Efficacy will be reported as change in right ventricular ejection fraction (RVEF) assessed as a percentage and will be measured via cardiac magnetic resonance (CMR) imaging.
Change in right ventricular mass index at diastole
Efficacy will be reported as change in right ventricular mass index at diastole assessed as g/m^2 and will be measured via serial cardiac magnetic resonance (CMR) imaging.
Change in right ventricular end-diastolic volume index (RVEDVI)
Efficacy will be reported as change in right ventricular end diastolic volume index (RVEDVI) assessed as ml/m^2 and will be measured via serial cardiac magnetic resonance (CMR) imaging.
Change in right ventricular end-systolic volume index (RVESVI)
Efficacy will be reported as change in right ventricular end systolic volume index (RVESVI) assessed as ml/m^2 and will be measured via serial cardiac magnetic resonance (CMR) imaging.
Change in right ventricular global longitudinal strain and strain rate
Efficacy will be reported as change in right ventricular global longitudinal strain and strain rate assessed as % and s^-1 respectively and will be measured via serial cardiac magnetic resonance (CMR) imaging.
Change in right ventricular global circumferential strain and strain rate
Efficacy will be reported as the change in right ventricular global circumferential strain and strain rate as % and s^-1 respectively, and will be measured via serial cardiac magnetic resonance (CMR) imaging.
Change in right atrial volume index
Efficacy will be reported as the change in right atrial volume index as ml/m^2 and will be measured via serial cardiac magnetic resonance (CMR) imaging.
Change in right ventricular work index
Efficacy will be reported as the change in right ventricular work index as (mmHg x mL x beats) / min and will be measured via serial cardiac magnetic resonance (CMR) imaging.
Change in tricuspid regurgitation severity
Efficacy will be reported as change in the categorical qualitative assessment of tricuspid valve regurgitation (trivial, mild, moderate, severe) and will be measured via transthoracic echocardiography.
Change in RV compliance/diastolic function
Efficacy will be reported as change in diastolic function as measured by the tricuspid E/E' ratio, evaluating the tricuspid inflow E and A velocities and ratio, and tricuspid annular DTI E'A' velocities. Function reported as normal diastolic function (no abnormalities in these measures), mildly impaired diastolic function (1 abnormal measure), moderately impaired diastolic function (2 abnormal measures), and severely impaired diastolic function (3 abnormal measures). These measures will be measured via transthoracic echocardiography.
Change in weight
Efficacy measured as change in participant's weight in kg and will be measured serially to assess change in somatic growth.
Change in length (height)
Efficacy measured as change in participant's length (height) in cm and will be measured serially to assess change in somatic growth.
Change in head circumference
Efficacy measured as change in participant's head circumference in cm and will be measured serially to assess change in somatic growth.
Change in N-Terminal Pro-Brain Natriuretic Peptide (NT-proBNP)
Efficacy measured as change in N-Terminal Pro-Brain Natriuretic Peptide (NT-proBNP) in pg/ml and will be measured serially by blood draw.
Change in modified Ross Heart Failure Classification score
The Ross Heart Failure Classification provides a global assessment of heart failure severity in infants. Efficacy measured as change in classification and will be measured serially via physician's assessment using the modified Ross Heart Failure Classification; classifications defined as Class 1 (no limitations of physical activity); Class 2 (may experience symptoms during moderate exercise but not during rest); Class 3 (symptoms with minimal exertion that interfere with normal daily activity); Class 4 (unable to carry out physical activity/has symptoms at rest that worsen with exertion).
Change in PedsQL™ Infant Scales
The PedsQL™ Infant Scales is a generic health related quality of life instrument specifically for healthy and ill infants ages 1-24 months. Efficacy measured as change in PedsQL total improvement score and will be measured serially by parental proxy-report. Higher scores are indicative of better quality of life.
Freedom from unplanned catheter intervention needed to address the pulmonary arteries or aorta.
Efficacy measured as the number and percentage of participants who do not undergo unplanned catheter interventions to address pulmonary arteries or the aorta.
Change in biomarkers/cytokines
Efficacy measured as change in biomarkers/cytokines in pg/ml and/or ng/ml and will be measured serially by blood draw.
Participants experiencing treatment emergent serious adverse events (TE-SAEs)
Safety will be reported as the number of participants experiencing treatment emergent serious adverse events (TE-SAEs) assessed by treating physician within the 30 days following study procedure. These include: greater than 30 seconds of sustained/symptomatic ventricular tachycardia requiring intervention; cardiogenic shock; unplanned cardiovascular operation for bleeding due to right ventricular intramyocardial injection site bleeding in the first five days after stage II palliation; worsening of cardiac function; local infection or systemic infection; need for new permanent pacemaker; death.
Participants experiencing major adverse cardiac events (MACE)
Safety will be reported as the number of participants with adjudicated events including cardiovascular morbidity; need for transplantation; re-hospitalizations; cardiovascular mortality; all-cause mortality.

Full Information

First Posted
June 8, 2021
Last Updated
April 1, 2023
Sponsor
Ann & Robert H Lurie Children's Hospital of Chicago
Collaborators
National Heart, Lung, and Blood Institute (NHLBI), The University of Texas Health Science Center, Houston, Longeveron Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04925024
Brief Title
Evaluation of Lomecel-B™ Injection in Patients With Hypoplastic Left Heart Syndrome: A Phase IIb Clinical Trial.
Acronym
ELPISII
Official Title
Evaluation of Lomecel-B™ Injection in Patients With Hypoplastic Left Heart Syndrome: A Phase IIb Clinical Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 25, 2021 (Actual)
Primary Completion Date
March 2025 (Anticipated)
Study Completion Date
August 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ann & Robert H Lurie Children's Hospital of Chicago
Collaborators
National Heart, Lung, and Blood Institute (NHLBI), The University of Texas Health Science Center, Houston, Longeveron Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to test whether Lomecel-B™ works in treating patients with hypoplastic left heart syndrome (HLHS) and to gather additional information about the safety of Lomecel-B. Lomecel-B contains human mesenchymal stem cells (MSCs) as the active ingredient. MSCs are special cells in the body that are able to change into other types of cells, such as heart, blood, and muscle cells. MSCs are found in various tissues of the body, such as the bone marrow, which is the spongy tissue inside of your bones. Lomecel-B uses MSCs from bone marrow of unrelated young healthy donors. These are called "allogeneic", and do not require donor matching to the patient.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypoplastic Left Heart Syndrome
Keywords
Hypoplastic Left Heart Syndrome, Pediatrics, Heart Defects, Congenital Cardiovascular Diseases, Stem Cells

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
38 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Lomecel B Group
Arm Type
Experimental
Arm Description
Participants randomized to receive Lomecel-B injections during their Stage II palliation.
Arm Title
No Study Intervention Control Group
Arm Type
No Intervention
Arm Description
Participants randomized to receive no study intervention during their Stage II palliation.
Intervention Type
Biological
Intervention Name(s)
Lomecel-B medicinal signaling cells
Intervention Description
A single administration of Lomecel-B will be performed via 6-10 intramyocardial injections into the right ventricle during the participant's standard of care stage II palliation. Dosing is based on body weight. Each patient will be given 2.5 x 10^5 cells per kg of body weight. The entire dose of the cells will be roughly 600 microliters.
Primary Outcome Measure Information:
Title
Change in right ventricular ejection fraction (RVEF)
Description
Efficacy will be reported as change in right ventricular ejection fraction (RVEF) assessed as a percentage and will be measured via cardiac magnetic resonance (CMR) imaging.
Time Frame
Baseline, 12 Months
Secondary Outcome Measure Information:
Title
Change in right ventricular ejection fraction (RVEF)
Description
Efficacy will be reported as change in right ventricular ejection fraction (RVEF) assessed as a percentage and will be measured via cardiac magnetic resonance (CMR) imaging.
Time Frame
Baseline, 6 Months
Title
Change in right ventricular mass index at diastole
Description
Efficacy will be reported as change in right ventricular mass index at diastole assessed as g/m^2 and will be measured via serial cardiac magnetic resonance (CMR) imaging.
Time Frame
Baseline, 12 Months
Title
Change in right ventricular end-diastolic volume index (RVEDVI)
Description
Efficacy will be reported as change in right ventricular end diastolic volume index (RVEDVI) assessed as ml/m^2 and will be measured via serial cardiac magnetic resonance (CMR) imaging.
Time Frame
Baseline, 12 Months
Title
Change in right ventricular end-systolic volume index (RVESVI)
Description
Efficacy will be reported as change in right ventricular end systolic volume index (RVESVI) assessed as ml/m^2 and will be measured via serial cardiac magnetic resonance (CMR) imaging.
Time Frame
Baseline, 12 Months
Title
Change in right ventricular global longitudinal strain and strain rate
Description
Efficacy will be reported as change in right ventricular global longitudinal strain and strain rate assessed as % and s^-1 respectively and will be measured via serial cardiac magnetic resonance (CMR) imaging.
Time Frame
Baseline, 12 Months
Title
Change in right ventricular global circumferential strain and strain rate
Description
Efficacy will be reported as the change in right ventricular global circumferential strain and strain rate as % and s^-1 respectively, and will be measured via serial cardiac magnetic resonance (CMR) imaging.
Time Frame
Baseline, 12 Months
Title
Change in right atrial volume index
Description
Efficacy will be reported as the change in right atrial volume index as ml/m^2 and will be measured via serial cardiac magnetic resonance (CMR) imaging.
Time Frame
Baseline, 12 Months
Title
Change in right ventricular work index
Description
Efficacy will be reported as the change in right ventricular work index as (mmHg x mL x beats) / min and will be measured via serial cardiac magnetic resonance (CMR) imaging.
Time Frame
Baseline, 12 Months
Title
Change in tricuspid regurgitation severity
Description
Efficacy will be reported as change in the categorical qualitative assessment of tricuspid valve regurgitation (trivial, mild, moderate, severe) and will be measured via transthoracic echocardiography.
Time Frame
Baseline, 12 Months
Title
Change in RV compliance/diastolic function
Description
Efficacy will be reported as change in diastolic function as measured by the tricuspid E/E' ratio, evaluating the tricuspid inflow E and A velocities and ratio, and tricuspid annular DTI E'A' velocities. Function reported as normal diastolic function (no abnormalities in these measures), mildly impaired diastolic function (1 abnormal measure), moderately impaired diastolic function (2 abnormal measures), and severely impaired diastolic function (3 abnormal measures). These measures will be measured via transthoracic echocardiography.
Time Frame
Baseline, 12 Months
Title
Change in weight
Description
Efficacy measured as change in participant's weight in kg and will be measured serially to assess change in somatic growth.
Time Frame
Baseline, 12 Months
Title
Change in length (height)
Description
Efficacy measured as change in participant's length (height) in cm and will be measured serially to assess change in somatic growth.
Time Frame
Baseline, 12 Months
Title
Change in head circumference
Description
Efficacy measured as change in participant's head circumference in cm and will be measured serially to assess change in somatic growth.
Time Frame
Baseline, 12 Months
Title
Change in N-Terminal Pro-Brain Natriuretic Peptide (NT-proBNP)
Description
Efficacy measured as change in N-Terminal Pro-Brain Natriuretic Peptide (NT-proBNP) in pg/ml and will be measured serially by blood draw.
Time Frame
Baseline, 12 Months
Title
Change in modified Ross Heart Failure Classification score
Description
The Ross Heart Failure Classification provides a global assessment of heart failure severity in infants. Efficacy measured as change in classification and will be measured serially via physician's assessment using the modified Ross Heart Failure Classification; classifications defined as Class 1 (no limitations of physical activity); Class 2 (may experience symptoms during moderate exercise but not during rest); Class 3 (symptoms with minimal exertion that interfere with normal daily activity); Class 4 (unable to carry out physical activity/has symptoms at rest that worsen with exertion).
Time Frame
Baseline, 12 Months
Title
Change in PedsQL™ Infant Scales
Description
The PedsQL™ Infant Scales is a generic health related quality of life instrument specifically for healthy and ill infants ages 1-24 months. Efficacy measured as change in PedsQL total improvement score and will be measured serially by parental proxy-report. Higher scores are indicative of better quality of life.
Time Frame
Baseline, 12 Months
Title
Freedom from unplanned catheter intervention needed to address the pulmonary arteries or aorta.
Description
Efficacy measured as the number and percentage of participants who do not undergo unplanned catheter interventions to address pulmonary arteries or the aorta.
Time Frame
Baseline, 12 Months
Title
Change in biomarkers/cytokines
Description
Efficacy measured as change in biomarkers/cytokines in pg/ml and/or ng/ml and will be measured serially by blood draw.
Time Frame
Baseline, 12 Months
Title
Participants experiencing treatment emergent serious adverse events (TE-SAEs)
Description
Safety will be reported as the number of participants experiencing treatment emergent serious adverse events (TE-SAEs) assessed by treating physician within the 30 days following study procedure. These include: greater than 30 seconds of sustained/symptomatic ventricular tachycardia requiring intervention; cardiogenic shock; unplanned cardiovascular operation for bleeding due to right ventricular intramyocardial injection site bleeding in the first five days after stage II palliation; worsening of cardiac function; local infection or systemic infection; need for new permanent pacemaker; death.
Time Frame
30 days post Stage II palliation
Title
Participants experiencing major adverse cardiac events (MACE)
Description
Safety will be reported as the number of participants with adjudicated events including cardiovascular morbidity; need for transplantation; re-hospitalizations; cardiovascular mortality; all-cause mortality.
Time Frame
Baseline, 12 Months

10. Eligibility

Sex
All
Maximum Age & Unit of Time
12 Months
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion: All participants must have HLHS (includes all types) requiring Stage II palliation (Glenn or Hemi-Fontan operation). Exclusion: Requirement for ongoing mechanical circulatory support immediately prior to Stage II palliation within 5 days Need for concomitant surgery for aortic coarctation or tricuspid valve repair or Endocardial fibroelastosis (EFE) resection or left ventricle recruitment procedures Undergoing the Stage I (Norwood) procedure that does not have HLHS Serum positivity for: human immunodeficiency virus (HIV); hepatitis B virus surface antigen (HBV BsAg); and/or viremic hepatitis C virus (HCV). This criterion can be ascertained by one of three ways: Documented history of mother's testing conducted during pregnancy Documented history of participants testing. If above documentation is not available blood will be obtained from participant at Screening/Baseline. Parent/guardian that is unwilling or unable to comply with necessary follow-up Unsuitability for the study based on the Investigator's clinical opinion Known hypersensitivity to dimethyl sulfoxide (DMSO) Presence of a pacemaker, or anticipated placement of a pacemaker, at the time of the Stage II palliation
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kathleen Van't Hof
Phone
312-227-1549
Email
KVantHof@luriechildrens.org
First Name & Middle Initial & Last Name or Official Title & Degree
Shelly Sayre
Phone
713-500-9529
Email
Shelly.L.Sayre@uth.tmc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sunjay Kaushal, MD, PhD
Organizational Affiliation
Ann & Robert H Lurie Children's Hospital of Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital of Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90027
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carly Weaver
Phone
323-361-8631
Email
cweaver@chla.usc.edu
First Name & Middle Initial & Last Name & Degree
Brandi Scott
Phone
323-361-7086
Email
bscott@chla.usc.edu
First Name & Middle Initial & Last Name & Degree
Ram Subramanyan, MD, PhD
Facility Name
Children's Healthcare of Atlanta
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emily Klingman, MSN, RN
Phone
404-785-7153
Email
emily.klingman@choa.org
First Name & Middle Initial & Last Name & Degree
Emily Elston
Phone
404-785-0535
Email
emily.elston@choa.org
First Name & Middle Initial & Last Name & Degree
William Mahle, MD
Facility Name
Advocate Children's Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60453
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bonnie Hughes, RN/BSN/CCRC
Phone
708-296-2214
Email
bonnie.hughes@aah.org
First Name & Middle Initial & Last Name & Degree
Mary Murray, RN/BSN/CCRC
Phone
708-684-4576
Email
mary.murray@aah.org
First Name & Middle Initial & Last Name & Degree
Narutoshi Hibino, MD
First Name & Middle Initial & Last Name & Degree
Rohit Loomba, MD
Facility Name
Ann & Robert H. Lurie Children's Hospital of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carmen Diaz-Leos
Phone
312-227-5395
Email
cdiazleos@luriechildrens.org
First Name & Middle Initial & Last Name & Degree
Stephanie Brazis
Phone
312-227-0201
Email
sbrazis@luriechildrens.org
First Name & Middle Initial & Last Name & Degree
Sunjay Kaushal, MD, PhD
Facility Name
Boston Children's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Bamgbose
Email
Michael.Bamgbose@cardio.chboston.org
First Name & Middle Initial & Last Name & Degree
Jonah Leighton
Phone
617-919-4457
Email
Jonah.Leighton@childrens.harvard.edu
First Name & Middle Initial & Last Name & Degree
Sitaram Emani, MD
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sarah Speed
Phone
513-803-7022
Email
Sarah.Speed@cchmc.org
First Name & Middle Initial & Last Name & Degree
Mariah Palmer
Phone
304-654-4437
Email
Mariah.Preast@cchmc.org
First Name & Middle Initial & Last Name & Degree
David Morales, MD
Facility Name
UTHealth-McGovern Medical School
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rebecca Sam
Phone
713-500-5746
Email
Rebecca.M.Sam@uth.tmc.edu
First Name & Middle Initial & Last Name & Degree
Rosie Munoz
Phone
713-500-7510
Email
Rosie.Munoz@uth.tmc.edu
First Name & Middle Initial & Last Name & Degree
Damien LaPar, MD
Facility Name
Primary Children's Hospital/University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84113
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Linda Lambert, ARPN
Phone
801-587-7523
Email
Linda.lambert@hsc.utah.edu
First Name & Middle Initial & Last Name & Degree
Adil Husain, MD
First Name & Middle Initial & Last Name & Degree
Edem Binka, MD

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36950450
Citation
Kaushal S, Hare JM, Hoffman JR, Boyd RM, Ramdas KN, Pietris N, Kutty S, Tweddell JS, Husain SA, Menon SC, Lambert LM, Danford DA, Kligerman SJ, Hibino N, Korutla L, Vallabhajosyula P, Campbell MJ, Khan A, Naioti E, Yousefi K, Mehranfard D, McClain-Moss L, Oliva AA, Davis ME. Intramyocardial cell-based therapy with Lomecel-B during bidirectional cavopulmonary anastomosis for hypoplastic left heart syndrome: the ELPIS phase I trial. Eur Heart J Open. 2023 Jan 11;3(2):oead002. doi: 10.1093/ehjopen/oead002. eCollection 2023 Mar.
Results Reference
background
Links:
URL
http://www.elpistrial.org
Description
ELPIS II study website
URL
https://clinicaltrials.gov/ct2/show/NCT03525418
Description
Earlier phase I study (ELPIS)

Learn more about this trial

Evaluation of Lomecel-B™ Injection in Patients With Hypoplastic Left Heart Syndrome: A Phase IIb Clinical Trial.

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