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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: Recruiting Phase 1 study, sponsored by Adia Med of Winter Park.
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, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Measured using the Visual Analog Scale (VAS-Average), a 0-10 scale assessing average low back pain intensity over the past week, with higher scores indicating greater pain severity.
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 |
What NCT07587047 shows while recruiting
NCT07587047 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (67% higher).
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 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07587047's enrollment target sits among peer trials
100 546th of 2000 higher than 1,411 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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