RECRUITING

A Phase 1 Open-Label Study of the Safety of Intravenous Allogeneic Neonatal Mesenchymal Cells (nMSCs) in Young Adult (1A) and Pediatric (1B) Patients With Dilated Cardiomyopathy (DCM)

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a Phase 1 study to determine the safety and efficacy of allogeneic neonatal mesenchymal stromal cells (nMSCs) for the treatment of Dilated Cardiomyopathy. The purpose of the study is to help doctors and scientists learn if allogeneic neonatal mesenchymal stromal cells (nMSCs) infusions are a safe and effective way to improve cardiac function and left ventricular ejection fraction.

Official Title

A Phase 1 Open-Label Study of the Safety of Intravenous Allogeneic Neonatal Mesenchymal Cells (nMSCs) in Young Adult (1A) and Pediatric (1B) Patients With Dilated Cardiomyopathy (DCM)

Quick Facts

Study Start:2025-07
Study Completion:2027-07
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06464588

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:4 Years to 30 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

William Mahle, MD
CONTACT
404-256-2593
wmahle@emory.edu

Principal Investigator

William Mahle, MD
PRINCIPAL_INVESTIGATOR
Emory University

Study Locations (Sites)

Hughes Spalding Children's Hospital
Atlanta, Georgia, 30303
United States
Egleston Children's Hospital
Atlanta, Georgia, 30322
United States
Emory Children's Center
Atlanta, Georgia, 30322
United States
Emory University Hospital
Atlanta, Georgia, 30322
United States
Scottish Rite Children's Hospital
Atlanta, Georgia, 30342
United States

Collaborators and Investigators

Sponsor: Emory University

  • William Mahle, MD, PRINCIPAL_INVESTIGATOR, Emory University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-07
Study Completion Date2027-07

Study Record Updates

Study Start Date2025-07
Study Completion Date2027-07

Terms related to this study

Keywords Provided by Researchers

  • Dilated Cardiomyopathy
  • Neonatal Mesenchymal Cells (nMSCs)

Additional Relevant MeSH Terms

  • Dilated Cardiomyopathy