PENSACOLA, Fla., May 30, 2023 /PRNewswire/ — Regenative Labs (Regenative), a leading HCT/P manufacturer, announces one of its observational study clinical sites, the Pain and Sleep Therapy Center, has sponsored its own independent study approved by the Institutional Review Board (IRB) of the Institute of Cellular and Regenerative Medicine.
Dr. Ryan Robinson and NP Rachel Reynolds will lead this prospective, single-site cohort study. The study will observe the benefits of applying Wharton’s jelly tissue allografts to cartilage defects in the temporomandibular joint and the implications on Mastication and TMJ translation.
Temporomandibular disorder (TMD) is a heterogeneous group of orofacial musculoskeletal and neuromuscular conditions involving the temporomandibular joint complex and surrounding masticatory muscles and skeletal components. TMD may be classified as intra-articular or extra-articular. Nearly 10 million patients suffer from TMD in the US annually, and it is recognized numerically as the most common chronic orofacial pain disorder.
Common disorder symptoms include persistent jaw pain, ear pain, headaches, referred pain to the neck and shoulders, and facial pain. Social, emotional, and cognitive triggers may exacerbate these symptoms. Nearly 18 million workdays are lost annually for every 100,000 working adults with symptomatic pain.
The current standard of care treatment for TMD includes simply resting the jaw muscle by avoiding use, massages and physical therapy, and medication management. When all other treatments fail, total joint replacement surgery is utilized in severe cases.
Regenative and the application of its Wharton’s jelly products offers an alternative to the current standard of care.
“Working with Wharton’s jelly has opened my eyes to the future for regenerative applications. We are so excited to have obtained IRB approval to not only help strengthen the growing body of evidence for Wharton’s jelly application but to also help the population of TMJ dysfunction sufferers who deserve more alternative interventions. I am thrilled to be able to offer cutting-edge technology to patients who would not get the same results with other care,” shared Rachel Reynolds MSN, FNP-C.
This study seeks to evaluate the safety of Wharton’s jelly tissue allograft applications as an alternative intervention for treatment-resistant TMD to surgery or other invasive last-resort procedures. The secondary objective aims to assess the efficacy and patient’s overall change in pain-related symptoms that pertain to bite force tolerance with mastication and lateral translation.
Patient outcomes will be assessed through a pain and symptom questionnaire that participants will answer at each visit, a CBCT scan, and randomized MRI scans. At the end of the study, the investigators will publish an article with a statistical evaluation of the change in articular space, range of motion, intra-articular cartilage health, and patient-reported levels before and after a Wharton’s jelly application to the TMJ compared to control group patients only receiving the standard care interventions.
“As the founder of the Pain and Sleep Therapy Center, my team and I pride ourselves on offering cutting-edge nonsurgical treatment for patients struggling with craniofacial pain, including TMD. Wharton’s jelly is easy to administer and has produced an environment for healing within the jaw joint complex better than we have seen with any other treatment modality. We are excited to be pioneers in bringing regenerative medicine into the TMJ world and create an advanced, progressive model for our patients,” concluded owner and Chief Clinical Director Ryan P. Robinson, DDS
This study is conducted and guided by an approved protocol from the Institute of Regenerative and Cellular Medicine IRB. Informed consent is obtained from each study participant. Patient safety will be maintained through informed consent, a comprehensive medical exam, and a history evaluation.
About Regenative Labs: Regenative Labs produces regenerative medicine products to address the root cause of a patient’s tissue defect using Wharton’s jelly innovations rather than masking the pain with other treatments. Regenative Labs works closely with scientists, physicians, hospitals, and surgery centers to constantly monitor and improve patient progress and outcomes for new product development. Formed by veteran industry professionals familiar with daily challenges of innovations in healthcare, the company provides non-addictive, non-invasive options for patients. Regenative Labs’ expert product research and development team complies with FDA guidelines of minimal manipulation for homologous use. The company adheres to AATB and FDA guidelines. Learn more at Regenative’s website: www.regenativelabs.com
About Dr. Ryan Robinson/Rachel Reynolds and the Pain and Sleep Therapy Center: Dr. Robinson is Delaware’s first doctor triple-boarded in Craniofacial Pain and Dental Sleep Medicine. After many years of treating the airway in his general dental practice, Dr. Robinson decided to open up a specialty practice to address the community’s needs. This new practice, called The Pain and Sleep Therapy Center of Delaware Valley, focuses on finding the origin of the problem as opposed to treating it with medications and “band-aid” fixes that have become so routine in today’s medical system. Originally, Rachel Reynolds is from upstate New York, where she completed her Bachelor of Nursing and Master of Nursing at Binghamton University. Prior to completing her Master, Rachel worked in Neurology as a registered nurse focusing on patients who dealt with chronic pain and headaches.