Biologic Augmentation of TMJ Arthroscopy Using BMAC

Biologic Augmentation of Temporomandibular Joint Arthroscopy Using Bone Marrow Aspirate Concentrate (BMAC): A Proposed Clinical Trial

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

Study Overview

• Status: Not yet recruiting
• Conditions: TMJ Pain; TMJ Arthralgia; TMJ - Oral &Maxillofacial Surgery; Oral and Maxillofacial Conditions
• Intervention / Treatment: Biological: Bone Marrow Aspirate Concentrate; Drug: Corticosteroid (CS)

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Jordan Augsburger; Phone Number: 212.746.5175; Email: joa7035@med.cornell.edu

Study Locations

• United States
  • New York
    • New York, New York, United States, 10024
      • Weill Cornell Medical College - NewYork-Presbyterian Hospital
      • Contact: Jordan Augsburger; Phone Number: 212.746.5175; Email: joa7035@med.cornell.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: BMAC Arm; Participants in this arm will receive BMAC injection during their TMJ arthroscopy procedure	Biological: Bone Marrow Aspirate Concentrate; Single dose injection of bone marrow fluid from the participant's anterior iliac crest (hip) into the TMJ area during arthroscopy.
Active Comparator: Corticosteroid Arm; Participants in this arm will receive steroid injection during their TMJ arthroscopy procedure	Drug: Corticosteroid (CS); Single dose injection of cortiosteroid into the TMJ area during arthroscopy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Maximum interincisal opening (MIO)	Distance measured on a ruler between the incisal edges in millimeters	Baseline , Procedure, 3 weeks post-op, 3 months post-op, 6 months post-op
Change in Pain Scores	Pain on Visual analogue score. Zero is equivalent to no pain and 10 indicates the worst possible pain.	Baseline, Procedure, 3 weeks post-op, 3 months post-op, 6 months post-op
Change in Jaw Functional Limitation Scale (JFLS) Score	JFLS is an 8 question survey on jaw functionality scored from 0 (no limitation) to 10 (severe limitation).	Baseline, Procedure, 3 weeks post-op, 3 months post-op, 6 months post-op

Collaborators and Investigators

• Sponsor: Weill Medical College of Cornell University
• Collaborators: Oral and Maxillofacial Surgery Foundation, Rosemont ,Illinois
• Investigators: Principal Investigator: Gwendolyn Reeve, DMD, Weill Medical College of Cornell University

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): June 1, 2028

Study Registration Dates

• First Submitted: April 10, 2026
• First Submitted That Met QC Criteria: April 10, 2026
• First Posted (Actual): April 17, 2026

Study Record Updates

• Last Update Posted (Actual): April 17, 2026
• Last Update Submitted That Met QC Criteria: April 10, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: BMAC; steroid; TMJ arthroscopy; bone marrow aspirate concentrate; TMJ pain; Oral and maxillofacial conditions
• Additional Relevant MeSH Terms: Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Adrenal Cortex Hormones
• Other Study ID Numbers: 25-08029208

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes