20 Participants NeededMy employer runs this trial

BMAC for Temporomandibular Joint Disorder

JA
Overseen ByJordan Augsburger
Age: 18+
Sex: Any
Trial Phase: Phase 3
Sponsor: Weill Medical College of Cornell University
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?

This trial tests a new treatment using Bone Marrow Aspirate Concentrate (BMAC) for individuals with temporomandibular joint disorder (TMJ pain) that hasn't improved with other treatments. Researchers aim to determine if BMAC injections during TMJ surgery can reduce inflammation and damage compared to the usual corticosteroid (CS) injections. Participants will be randomly assigned to receive either BMAC or steroids during their procedure. Suitable candidates for this trial should have ongoing TMJ pain and dysfunction despite trying treatments like pain relievers or physical therapy for at least 30 days. As a Phase 3 trial, this study represents the final step before FDA approval, offering a chance to contribute to potentially groundbreaking treatment advancements.

Do I have to stop taking my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, since the trial involves comparing BMAC to corticosteroid injections, it's possible that some medications might need to be adjusted. Please consult with the trial coordinators for specific guidance.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Bone Marrow Aspirate Concentrate (BMAC) is usually well-tolerated for joint issues. One study found that BMAC injections improved symptoms of temporomandibular joint (TMJ) disorders without causing major side effects. Another study demonstrated that a single BMAC injection was safe and improved knee osteoarthritis, suggesting it might also be safe for other joints like the TMJ. BMAC aims to ease symptoms and help repair joint tissues. While these results are encouraging, they rely on previous studies. Participants should consider this information when deciding whether to join the trial.12345

Why do researchers think this study treatment might be promising for TMJ?

Researchers are excited about the use of Bone Marrow Aspirate Concentrate (BMAC) for treating Temporomandibular Joint (TMJ) Disorder because it introduces a regenerative approach to healing. Unlike standard treatments like corticosteroid injections that focus mainly on reducing inflammation and pain, BMAC is derived from the patient's own bone marrow and contains cells that have the potential to repair and regenerate joint tissues. This could mean longer-lasting relief and improved joint function compared to current options. By harnessing the body's natural healing processes, BMAC offers a promising alternative for patients suffering from TMJ disorders.

What evidence suggests that this trial's treatments could be effective for TMJ disorder?

Research suggests that Bone Marrow Aspirate Concentrate (BMAC) may help treat jaw joint disorders. In this trial, participants in the BMAC arm will receive BMAC injections during their TMJ arthroscopy procedure. Studies have shown that BMAC can repair damage from jaw joint arthritis, leading to improved jaw movement and reduced pain. In one study, patients who received BMAC injections reported greater improvement in jaw function and pain relief than those who did not. Another study found that individuals with jaw joint disorders experienced better outcomes after receiving BMAC injections. While these findings are encouraging, further research is needed to confirm its effectiveness in larger groups.23567

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?

This trial is for adults aged 18–75 with ongoing jaw joint pain (TMJ disorder) that hasn't improved after at least a month of standard treatments like medications, splints, or physical therapy. Participants must be able to give consent and have moderate or worse pain.

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)

Trial Overview

The study compares two treatments during TMJ arthroscopy: one group gets an injection of Bone Marrow Aspirate Concentrate (BMAC), while the other receives a corticosteroid injection. Patients are randomly assigned to each group and followed for six months.

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+

Citations

Bone marrow aspirate concentrate – A novel approach to ...

Bone marrow aspirate concentrate (BMAC) is able to reverse the degenerative effects of TMJ OA. However, further studies are mandatory with larger population and ...

Arthrocentesis for temporomandibular joint disorders - PMC

Clinical studies have demonstrated the effectiveness of arthrocentesis in managing temporomandibular joint disorders (TMDs). However, there is a lack of ...

3.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/37748708/

Bone marrow aspirate concentrate - A novel approach to ...

Conclusion: Bone marrow aspirate concentrate (BMAC) is able to reverse the degenerative effects of TMJ OA however,further studies are mandatory ...

Bone Marrow Aspirate Concentrate – A Novel approach to ...

Similarly, Fayed et al. found that, after 1 week and 1 month, the test group showed significantly greater improvements in mandibular function and reduced ...

BMAC for Temporomandibular Joint Disorder

The goal of this clinical trial is to learn about the efficacy of using Bone Marrow Aspirate Concentrate (BMAC) during temporomandibular joint ( ...

Clinical Outcomes of Autologous Bone Marrow Aspirate ...

The purpose of this study is collect a longitudinal case series of patient reported outcomes following BMAC injections for musculoskeletal conditions including ...

7.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/31601466/

1-year results of a randomized clinical trial

Intra-articular TMJ BMNc injection improved clinical outcomes in TMD treatment. The Results of this first human-model study are promising.