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.
https://painandsleepcenter.com/
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SOURCE Regenative Labs