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NCT04484077 · ClinicalTrials.gov registry record · Phase 1
hCT-MSC Infusion in Adults With Autism Spectrum Disorder
A Phase 1 study, sponsored by Joanne Kurtzberg, MD.
- Completed
- Registry status
- Phase 1
- Development phase
- 8
- Enrollment target
NCT04484077 is a Phase 1 study that has completed, run by Joanne Kurtzberg, MD. The registered enrollment target is 8 participants.
The verdict
NCT04484077, a Phase 1 study, has completed, sponsored by Joanne Kurtzberg, MD.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 8 participants
- Enrollment target
Study Summary
The purpose of the study is to determine the safety and tolerability of a single intravenous dose of Human Umbilical Cord Tissue Derived Mesenchymal Stromal Cells (hCT-MSC) in adults with autism spectrum disorder (ASD). hCT-MSC is a cell product isolated from umbilical cord tissue. The cells from the cord tissue are processed and expanded in the laboratory and then infused intravenously in a single dose per participant. Participants will be ages 18-35 years, with ASD and a full-scale IQ \>70 without an identified genetic cause of autism. Participants will have an in-person baseline visit and remote follow up visits at 6 and 12 months. In addition to the primary endpoints evaluating safety, the study will evaluate changes in social communications skills after hCT-MSC administration.
Interventions
- BIOLOGICAL hCT-MSC
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 8 participants |
| Start Date | 2022-01-24 |
| Est. Completion | 2024-04-29 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04484077
The ClinicalTrials.gov registry entry for NCT04484077 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 8 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Joanne Kurtzberg, MD, which has 15 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which hCT-MSC is the first listed.
NCT04484077 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04484077 about?
NCT04484077 is a clinical study titled "hCT-MSC Infusion in Adults With Autism Spectrum Disorder". The purpose of the study is to determine the safety and tolerability of a single intravenous dose of Human Umbilical Cord Tissue Derived Mesenchymal Stromal Cells (hCT-MSC) in adults with autism spectrum disorder (ASD). hCT-MSC is a cell product isolated from umbilical cord tissue. The cells from th...
What is the current status of trial NCT04484077?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 8 participants. The study started on 2022-01-24. Estimated completion is 2024-04-29.
What interventions are being tested in trial NCT04484077?
The interventions under investigation include: hCT-MSC (BIOLOGICAL).
Who is sponsoring clinical trial NCT04484077?
This trial is sponsored by Joanne Kurtzberg, MD, which has 15 total clinical trials registered on ClinicalTrials.gov.
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