ROSWELL, Ga., June 19, 2018 /PRNewswire/ -- StimLabs, a leader in regenerative technologies and products that are revolutionizing patient care, today announced that the first patient has been enrolled in the company sponsored clinical trial assessing the safety and efficacy of Revita full thickness placental allograft placement following lumbar microdiscectomy procedures.
The multi-center randomized controlled trial will evaluate the efficacy of Revita in improving clinical outcomes, such as back and leg pain, post-microdiscectomy. Revita is the first amniotic tissue derived allograft to capture the complete, intact membrane in a shelf-stable format and is intended to be used as a barrier membrane for surgical applications.
Microdiscectomy is a routine procedure conducted to remove herniated vertebral disc material that is compressing the spine or spinal nerves. Common complications following microdiscectomy procedures using the current standard of care include scar tissue formation and reherniation. The use of a barrier membrane, such as Revita, during microdiscectomy procedures is expected to reduce the rate of occurrence for these types of complications and improve functional outcomes.
"We are pleased to enroll our first patient in our Revita efficacy trial for lumbar microdiscectomy," says John Daniel, CEO and founder. "The commencement of this study is an important step to supporting our commitment to providing safe and effective care through clinically-validated treatment."
The study is a randomized, controlled, single-blinded (patient) trial that will evaluate the efficacy of Revita full thickness placental allografts in improving leg and back pain post-microdiscectomy. The trial focuses on male and female patients undergoing lumbar microdiscectomy between 18 and 70 years of age. The target enrollment to obtain statistical significance is 182 patients. Patients will be randomized to either the treatment or control group. The treatment group, 91 patients, will undergo a typical microdiscectomy procedure with the addition of a Revita allograft used as a barrier membrane. The control group will undergo a typical microdiscectomy procedure followed by the current standard of care per facility protocols. The Oswestry Disability Index (ODI) and a 12-Item Short Form Survey (SF-12) will be used to quantitatively evaluate back and leg pain post-procedure. The study will also evaluate the rate of reherniation in both the treatment and control groups.
To learn more about the study, please visit www.clinicaltrials.gov.
Revita is the first placental membrane allograft to capture the complete intact membrane in a shelf-stable format. Revita is uniquely processed using the patent-pending Clearify™ process to preserve all three layers of the biologic tissue and maintain the physiologic 3D architecture of the natural barrier membrane. By capturing more native placental proteins, growth factors, and glycoproteins, Revita maximizes the capabilities of the placental tissue. The Clearify process gently removes unwanted constituents from the placental membrane, yielding a safe, sterile product. The processed full thickness membrane is presented in dehydrated form, cut into various sizes, and terminally sterilized for a variety of applications.
Revita is donated human tissue regulated by the United States Food and Drug Administration (FDA) as a human cell, tissue, or cellular or tissue-based product (HCT/P) under Section 361 of the Public Health Service (PHS) Act. Revita allografts are aseptically processed and terminally sterilized according to FDA current Good Tissue Practice requirements and the American Association of Tissue Banks (AATB) Standards for Tissue Banking (14th ed.). StimLabs is registered with the FDA as a Tissue Establishment, is accredited by the AATB, and meets all state and federal requirements for processing and distributing human tissue.
StimLabs, LLC, was founded in 2015 with a desire to advance the state of regenerative medicine. Within a year of its inception, StimLabs built and certified an ISO Class 7 clean room facility, conceptualized and launched a suite of amniotic-derived products, developed an extensive product pipeline across a range of clinical applications, and established a portfolio of intellectual property. StimLabs portfolio of products includes Ascent™, a shelf-stable injectable cell and protein allograft derived from human amniotic fluid, and Revita®, an intact human placental membrane allograft that preserves all layers of the native tissue in a shelf-stable format. These groundbreaking products apply to a wide range of clinical applications and provide a foundation on which StimLabs is developing new regenerative technologies at the intersection of pharmaceuticals, medical devices, and tissue transplants. For more information, visit www.stimlabs.com.