Biologic Augmentation of TMJ Arthroscopy Using BMAC

NCT07536399 | Not Yet Recruiting Phase 3 FDA Drug

• 1 other identifier: 25-08029208
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn about the efficacy of using Bone Marrow Aspirate Concentrate (BMAC) during temporomandibular joint (TMJ) arthroscopy compared to standard arthroscopic procedures with corticosteroid (CS) injections in patients with pain (arthralgia) of the temporomandibular joint (TMJ) that has failed to respond to conservative treatment. The main question it aims to answer: Does BMAC injection reduce the amount of inflammation and structural damage in the TMJ? Researchers will compare BMAC injection to corticosteroid injections see if BMAC injection helps . Participants will :

• Be randomized to receive either BMAC or CS injection during TMJ arthroscopy
• Visit the clinic for 3 follow up visits over 6 months and answer questionnaires
• have 2 MRIs of their jaw

Conditions

TMJ - Oral &Maxillofacial Surgery; Oral and Maxillofacial Conditions; TMJ Pain; TMJ Arthralgia

Keywords

TMJ pain; Oral and maxillofacial conditions; TMJ arthroscopy; bone marrow aspirate concentrate; BMAC; steroid

Outcome Measures

Primary Outcomes (1)

• Change from Baseline in Kellenberger score at 6 Months.

  Participant MRIs will be given a Kellenberger score of 0-13. A higher Kellenberger scores indicate a higher degree of inflammation and damage.

  Baseline; 6 months

Secondary Outcomes (3)

• Change in Maximum interincisal opening (MIO)

  Baseline , Procedure, 3 weeks post-op, 3 months post-op, 6 months post-op

• Change in Pain Scores

  Baseline, Procedure, 3 weeks post-op, 3 months post-op, 6 months post-op

• Change in Jaw Functional Limitation Scale (JFLS) Score

  Baseline, Procedure, 3 weeks post-op, 3 months post-op, 6 months post-op

Study Arms (2)

BMAC Arm

EXPERIMENTAL

Participants in this arm will receive BMAC injection during their TMJ arthroscopy procedure

Biological: Bone Marrow Aspirate Concentrate

Corticosteroid Arm

ACTIVE COMPARATOR

Participants in this arm will receive steroid injection during their TMJ arthroscopy procedure

Drug: Corticosteroid (CS)

Interventions

Bone Marrow Aspirate Concentrate BIOLOGICAL

Single dose injection of bone marrow fluid from the participant's anterior iliac crest (hip) into the TMJ area during arthroscopy.

BMAC Arm

Corticosteroid (CS) DRUG

Single dose injection of cortiosteroid into the TMJ area during arthroscopy.

Corticosteroid Arm

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participant is at least 18 years of age and not older than 75 years of age
• Participant is willing and able to provide written informed consent to participant in this study
• 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.)
• Participant has baseline pain of ≥30 on a 100mm visual analog scale (VAS)

You may not qualify if:

• Participant has not competed at least 30 days of conservative therapy
• Participant was diagnosed with central or neuropathic pain disorder
• Participant has a primary diagnosis of myofascial pain
• Participant has fibromyalgia
• Participant is pregnant or breastfeeding
• Participant had traumatic injury to the masticatory muscles or temporomandibular joint within 12 months of screening
• 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

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• Oral and Maxillofacial Surgery Foundation, Rosemont ,Illinois: collaborator

Study Sites (1)

Weill Cornell Medical College - NewYork-Presbyterian Hospital

New York, New York, 10024, United States

Location

MeSH Terms

Interventions

Adrenal Cortex Hormones

Intervention Hierarchy (Ancestors)

Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Gwendolyn Reeve, DMD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jordan Augsburger

CONTACT

212.746.5175; JOA7035@MED.CORNELL.EDU

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2026
• First Posted: April 17, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: April 17, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)