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BMAC for Temporomandibular Joint Disorder

JA
Overseen ByJordan Augsburger
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Weill Medical College of Cornell University
Disqualifiers: Central pain disorder, Myofascial pain, Fibromyalgia, Pregnancy, others
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this 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

Who Is on the Research Team?

GR

Gwendolyn Reeve, DMD

Principal Investigator

Weill Medical College of Cornell University

Are You a Good Fit for This Trial?

Inclusion Criteria

I am between 18 and 75 years old.
I am willing and able to give written consent to join this study.
I have pain that is at least 30 out of 100 on a pain scale.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to receive either BMAC or CS injection during TMJ arthroscopy

1 day
1 visit (in-person)

Follow-up

Participants visit the clinic for follow-up assessments and MRIs

6 months
3 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

  • Bone Marrow Aspirate Concentrate (BMAC)
  • Corticosteroid (CS)

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Active Control

Group I: BMAC ArmExperimental Treatment1 Intervention
Group II: Corticosteroid ArmActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Weill Medical College of Cornell University

Lead Sponsor

Trials
1,103
Recruited
1,157,000+

Oral and Maxillofacial Surgery Foundation, Rosemont ,Illinois

Collaborator

Trials
1
Recruited
130+

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