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NCT06464588 · ClinicalTrials.gov registry record · Phase 1
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)
A Phase 1 study of Dilated Cardiomyopathy, sponsored by Emory University.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 36
- Enrollment target
- 5
- Study locations
NCT06464588: Recruiting Phase 1 study of Dilated Cardiomyopathy, sponsored by Emory University.
NCT06464588 is a Phase 1 study of Dilated Cardiomyopathy that is actively recruiting participants, run by Emory University. The registered enrollment target is 36 participants, below the 257-participant average among 6 other Dilated Cardiomyopathy trials with a reported enrollment target (86% lower). The trial reports 5 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06464588, a Phase 1 study of Dilated Cardiomyopathy, is actively recruiting participants, sponsored by Emory University.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 36 participants
- Enrollment target
- 5
- Study locations
Study Summary
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.
Primary Outcome
Proportion of participants with freedom from any Common Toxicity Criteria for Adverse Events (CTCAE) Grade 3 or greater AE that is probably or related to the IP throughout the duration of the study will be recorded. Results can vary from 0 to 100% and higher proportion correlates with better outcome. TCAE Grade 3 is defined as severe or medically significant not immediately life-threatening; hospitalization or prolongation of hospitalization. Grade 4 and 5 AEs include composite of: death, life
Conditions Studied
Interventions
- BIOLOGICAL Allogeneic Neonatal mesenchymal stromal cells (nMSCs)
Study Locations (5)
Georgia
- Hughes Spalding Children's Hospital - Atlanta
- Egleston Children's Hospital - Atlanta
- Emory Children's Center - Atlanta
- Emory University Hospital - Atlanta
- Scottish Rite Children's Hospital - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2025-07-14 |
| Est. Completion | 2027-07 |
| Phase | Phase 1 |
What NCT06464588 shows while recruiting
NCT06464588 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 257-participant average among 6 other Dilated Cardiomyopathy trials with a reported enrollment target (86% lower).
The record links to 1 condition, with Dilated Cardiomyopathy appearing as the primary indexed condition, and to 1 intervention - of which Allogeneic Neonatal mesenchymal stromal cells (nMSCs) is the first listed.
NCT06464588 lists 5 locations in 1 state (Georgia).
Frequently Asked Questions
What is clinical trial NCT06464588 about?
NCT06464588 is a clinical study titled "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)". 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...
What is the current status of trial NCT06464588?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2025-07-14. Estimated completion is 2027-07.
What conditions does trial NCT06464588 study?
This clinical trial studies the following conditions: Dilated Cardiomyopathy.
What interventions are being tested in trial NCT06464588?
The interventions under investigation include: Allogeneic Neonatal mesenchymal stromal cells (nMSCs) (BIOLOGICAL).
Who is sponsoring clinical trial NCT06464588?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06464588 being conducted?
This trial has 5 study locations across Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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