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Allogeneic hMSC Injection in Patients With Hypoplastic Left Heart Syndrome

NCT02398604 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2021-07-19

No results posted yet for this study

Summary

This study is intended to evaluate the safety and feasibility of intramyocardial injection of allogeneic mesenchymal cells during the Bi-Directional Cavopulmonary Anastomosis (BDCPA) surgery for hypoplastic left heart syndrome (HLHS) pediatric patients.

Conditions

Interventions

DRUG

Allo-hMSCs

Allogeneic Human Mesenchymal Stem Cells

DRUG

Placebo

Placebo

Sponsors & Collaborators

Principal Investigators

  • Anthony Oliva, MD · Longeveron Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
30 Days
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-30
Primary Completion
2019-03-31
Completion
2019-03-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02398604 on ClinicalTrials.gov