Biologic augmentation of TMJ arthroscopy with bone marrow concentrate
Official title: Biologic Augmentation of Temporomandibular Joint Arthroscopy Using Bone Marrow Aspirate Concentrate (BMAC): A Proposed Clinical Trial
Run by Weill Medical College of Cornell University · NCT07536399 · Data updated 2026-11-12
This trial tests whether injecting bone marrow aspirate concentrate during TMJ arthroscopy helps reduce pain and joint damage more than standard corticosteroid injections in adults with TMJ pain not responding to conservative care.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | Weill Medical College of Cornell University Academic / other |
| Locations | 1 site (New York, New York) |
| Status | Recruiting |
| Started | May 1, 2026 |
| Main results expected | December 2027 |
| Study ends | June 2028 |
| Registry record updated | July 29, 2026 |
| Trial ID | NCT07536399 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18 to 75 with TMJ arthralgia who have not responded to at least 30 days of conservative therapy and have baseline pain of 30 or higher on a 100-mm visual analog scale.
✕Probably not a fit
Individuals who do not experience reduced inflammation or improved joint structure after BMAC may not see a benefit and could undergo standard care alternatives.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase 3 interventional trial compares Bone Marrow Aspiration Concentrate (BMAC) to corticosteroid injections when used during TMJ arthroscopy in adults with persistent TMJ arthralgia. Participants are randomized to receive either BMAC or corticosteroid, and will have three follow-up visits over six months plus two jaw MRI assessments. The study aims to determine if BMAC can reduce inflammation and structural changes in the TMJ compared with the standard approach. Primary outcomes include pain, function, and imaging findings, with safety monitoring throughout the trial.
Why it matters
Potential benefit: If successful, BMAC during TMJ arthroscopy could reduce pain and improve joint function compared with corticosteroid treatment.
How similar studies have gone: Previous studies in related joints suggest biologic marrow-derived therapies can impact inflammation and healing, but results vary and this approach in TMJ is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Participant is at least 18 years of age and not older than 75 years of age 2. Participant is willing and able to provide written informed consent to participant in this study 3. Participant has symptoms of TMJ arthralgia (pain) with significant temporomandibular joint pain and dysfunction despite at least 30 days of conservative therapy (NSAIDS, muscle relaxants, bite splints, PT, warm compresses, soft diet, etc.) 4. Participant has baseline pain of ≥30 on a 100mm visual analog scale (VAS) Exclusion Criteria: 1. Participant has not competed at least 30 days of conservative therapy 2. Participant was diagnosed with central or neuropathic pain disorder 3. Participant has a primary diagnosis of myofascial pain 4. Participant has fibromyalgia 5. Participant is pregnant or breastfeeding 6. Participant had traumatic injury to the masticatory muscles or temporomandibular joint within 12 months of screening 7. Participant who has the following contraindications to MRI: * Electrical implants such as cardiac pacemakers or perfusion pumps * Ferromagnetic implants such as aneurysm clips, surgical clips, prostheses, artificial heart, valves with steel parts, metal fragments, shrapnel, bullets, tattoos near the eye, or steel implants * History of seizures * Patients with GFR \< 15 ml/min/1.73m2 or who are on dialysis will be excluded from the study. * Allergy to contrast die
Where it's running
-
Weill Cornell Medical College - NewYork-Presbyterian Hospital
New York, New York, United States Recruiting
Study contacts
- Principal investigator: Gwendolyn Reeve, DMD — Weill Medical College of Cornell University
- Study coordinator: Jordan Augsburger
- Email: JOA7035@MED.CORNELL.EDU
- Phone: 212.746.5175
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.