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NCT07587047 · ClinicalTrials.gov registry record · Phase 1
Adia Med of Winter Park LLC Lower Back Pain Research Study
A Phase 1 study, sponsored by Adia Med of Winter Park.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 100
- Enrollment target
NCT07587047 is a Phase 1 study that is actively recruiting participants, run by Adia Med of Winter Park. The registered enrollment target is 100 participants.
The verdict
NCT07587047, a Phase 1 study, is actively recruiting participants, sponsored by Adia Med of Winter Park.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 100 participants
- Enrollment target
Study Summary
The goal of this clinical study is to evaluate the safety and preliminary efficacy of an investigational umbilical cord blood-derived stem cell and exosome infusion in adults with chronic lower back pain associated with degenerative spine disease. The primary questions this study aims to answer are whether the investigational infusion is safe and well tolerated and whether treatment may reduce pain and improve physical function and quality of life. Researchers will compare the investigational infusion to a placebo (saline solution) to evaluate potential treatment effects in participants with chronic mechanical lower back pain. Participants will receive either the investigational infusion or placebo intravenously during a study visit, complete pain, disability, and quality-of-life assessments, undergo magnetic resonance imaging (MRI) and laboratory testing, and attend follow-up evaluations over a 6-month period. Participants initially assigned to placebo may later receive the investigational treatment during an open-label crossover phase of the study.
Interventions
- BIOLOGICAL Umbilical Cord Blood-Derived Stem Cells and Exosomes
- OTHER Placebo IV
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2026-06-16 |
| Est. Completion | 2028-01 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07587047
The ClinicalTrials.gov registry entry for NCT07587047 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Adia Med of Winter Park, which has 3 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Umbilical Cord Blood-Derived Stem Cells and Exosomes is the first listed.
NCT07587047 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07587047 about?
NCT07587047 is a clinical study titled "Adia Med of Winter Park LLC Lower Back Pain Research Study". The goal of this clinical study is to evaluate the safety and preliminary efficacy of an investigational umbilical cord blood-derived stem cell and exosome infusion in adults with chronic lower back pain associated with degenerative spine disease. The primary questions this study aims to answer are ...
What is the current status of trial NCT07587047?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 100 participants. The study started on 2026-06-16. Estimated completion is 2028-01.
What interventions are being tested in trial NCT07587047?
The interventions under investigation include: Umbilical Cord Blood-Derived Stem Cells and Exosomes (BIOLOGICAL), Placebo IV (OTHER).
Who is sponsoring clinical trial NCT07587047?
This trial is sponsored by Adia Med of Winter Park, which has 3 total clinical trials registered on ClinicalTrials.gov.
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