Tuesday, May 30, 2023
Regenative Labs (Regenative), a leading manufacturer of human cellular and tissue-based products (HCT/P), has announced an independent observational study sponsored by one of its clinical sites, the Pain and Sleep Therapy Center. The study has received approval from the Institutional Review Board (IRB) of the Institute of Cellular and Regenerative Medicine.
Dr. Ryan Robinson and NP Rachel Reynolds will lead this prospective cohort study, which aims to observe the benefits of using Wharton's jelly tissue allografts for treating cartilage defects in the temporomandibular joint (TMJ) and its implications on mastication and TMJ translation.
Temporomandibular disorder (TMD) is a heterogeneous group of orofacial musculoskeletal and neuromuscular conditions involving the temporomandibular joint complex, masticatory muscles, and skeletal components. TMD can be categorized as intra-articular or extra-articular. In the United States, TMD affects nearly 10 million patients annually and is recognized as the most common chronic orofacial pain disorder.
Common symptoms of TMD include persistent jaw pain, ear pain, headaches, referred pain to the neck and shoulders, and facial pain. These symptoms can be exacerbated by social, emotional, and cognitive triggers. Symptomatic pain results in the loss of approximately 18 million workdays annually for every 100,000 working adults.
The current standard of care for TMD involves resting the jaw muscles, avoiding use, massages, physical therapy, and medication management. In severe cases where other treatments fail, total joint replacement surgery is utilized. Regenative and its Wharton's jelly products offer an alternative to the current standard of care.
Rachel Reynolds MSN, FNP-C, expressed enthusiasm about the potential of Wharton's jelly for regenerative applications. She is thrilled that the IRB has
approved the study, as it will not only contribute to the growing body of evidence for Wharton's jelly application but also provide alternative interventions for individuals with TMJ dysfunction. Reynolds looks forward to offering cutting-edge technology to patients who may not achieve the same results with other treatments.
The primary objective of this study is to evaluate the safety of using Wharton's jelly tissue allografts as an alternative intervention for treatment-resistant TMD, instead of surgery or other invasive last-resort procedures. The secondary objective aims to assess the efficacy of this treatment and measure the overall change in pain-related symptoms, particularly related to bite force tolerance during mastication and lateral translation.
Patient outcomes will be assessed through a pain and symptom questionnaire administered at each visit, as well as CBCT scans and randomized MRI scans. The study investigators will publish an article at the end of the study, presenting a statistical evaluation of the changes in articular space, range of motion, intra-articular cartilage health, and patient-reported levels of pain before and after the application of Wharton's jelly to the TMJ, comparing them to the control group receiving standard care interventions.
Dr. Ryan P. Robinson, owner and Chief Clinical Director of the Pain and Sleep Therapy Center, emphasizes their commitment to providing advanced non-surgical treatments for craniofacial pain, including TMD. He highlights the ease of administering Wharton's jelly and its ability to create a healing environment within the jaw joint complex that surpasses other treatment modalities. Dr. Robinson is excited to pioneer regenerative medicine in the TMJ field and develop an advanced and progressive model of care for their patients.
This study is being conducted according to an approved protocol from the Institute of Regenerative and Cellular Medicine IRB. Informed consent is obtained from each study participant, and patient safety is ensured through a comprehensive medical examination and evaluation of medical history.