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NCT03818737 · ClinicalTrials.gov registry record · Phase 3
Multicenter Trial of Stem Cell Therapy for Osteoarthritis (MILES)
A Phase 3 study, sponsored by Emory University.
- Completed
- Registry status
- Phase 3
- Development phase
- 475
- Enrollment target
NCT03818737: Completed Phase 3 study, sponsored by Emory University.
NCT03818737 is a Phase 3 study that has completed, run by Emory University. The registered enrollment target is 475 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (38% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03818737, a Phase 3 study, has completed, sponsored by Emory University.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 475 participants
- Enrollment target
Study Summary
The study is a multicenter trial conducted to compare the effectiveness of an injection of a corticosteroid control to mesenchymal stem cell (MSC) preparations from autologous bone marrow concentrate (BMAC), adipose derived stem cells in the form of Stromal Vascular Fraction (SVF), and third-party human mesenchymal stem cells manufactured from umbilical cord tissue (UCT) for the treatment of unilateral Knee Osteoarthritis (OA). The study will be conducted in 4 sites in the United States, and a total of 480 participants will be enrolled in this study.
Primary Outcome
Pain assessment was performed using the Visual Analog Pain Scale (VAS-pain). The VAS-pain is self-completed by the participant. The respondent is asked to place a line perpendicular to the VAS line at the point that represents their pain intensity. Using a ruler, the score is determined by measuring the distance in millimeters (mm) on the line between the "no pain" anchor and the participant's mark, providing a range of scores from 0-100. The recommended cut points for VAS are: no pain (0-4 mm),
Interventions
- DRUG Corticosteroid injection
- BIOLOGICAL Bone Marrow Derived MSCs
- BIOLOGICAL Adipose-derived MSCs
- BIOLOGICAL Umbilical Cord Tissue (UCT) MSCs
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 475 participants |
| Start Date | 2019-03-28 |
| Est. Completion | 2022-05-31 |
| Phase | Phase 3 |
What the finished NCT03818737 record still lists
NCT03818737 is an interventional study that assigns participants to a tested intervention. The registered 475 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (38% lower).
The record links to 0 conditions, and to 4 interventions - of which Corticosteroid injection is the first listed.
NCT03818737 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03818737 about?
NCT03818737 is a clinical study titled "Multicenter Trial of Stem Cell Therapy for Osteoarthritis (MILES)". The study is a multicenter trial conducted to compare the effectiveness of an injection of a corticosteroid control to mesenchymal stem cell (MSC) preparations from autologous bone marrow concentrate (BMAC), adipose derived stem cells in the form of Stromal Vascular Fraction (SVF), and third-party h...
What is the current status of trial NCT03818737?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 475 participants. The study started on 2019-03-28. Estimated completion is 2022-05-31.
What interventions are being tested in trial NCT03818737?
The interventions under investigation include: Corticosteroid injection (DRUG), Bone Marrow Derived MSCs (BIOLOGICAL), Adipose-derived MSCs (BIOLOGICAL), Umbilical Cord Tissue (UCT) MSCs (BIOLOGICAL).
Who is sponsoring clinical trial NCT03818737?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03818737's enrollment target sits among peer trials
475 808th of 2000 higher than 1,191 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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