ROSWELL, Ga., Feb. 1, 2019 /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's clinical trial assessing the safety and efficacy of Revita as a wound covering for diabetic foot ulcers (DFUs).
The multi-center randomized, controlled study will evaluate the efficacy of Revita in improving wound closure rates in DFUs as compared to current standards of wound care treatment. Revita is the first amniotic allograft to capture the complete, intact membrane in a shelf-stable format.
"We are thrilled to commence patient enrollment in this key DFU study," said John Daniel, Founder and CEO of StimLabs. "As the first intact, shelf-stable placental membrane, Revita has set a new standard for amniotic tissue products, and the clinical outcomes we've seen across the country have been exceptional. This study will build on the evidence we've collected to date, and validate the feedback we've received. We're also excited to leverage the power of Tissue Analytics for this study. This unique platform uses machine learning to more accurately evaluate wound characteristics, increasing the accuracy and integrity of our outcomes data."
Diabetes is on the rise and affects approximately 30 million people in the United States1. As many as 25% of patients with diabetes will develop a DFU within their lifetime.2 Of that total, up to 24% of those individuals' condition will lead to an amputation.3 Amputated patients have around a 50% survival rate.4 In addition to these outcomes, DFUs are also a major financial burden on the health care system. Care for DFUs costs public and private payers approximately $9–13 billion annually, in addition to the costs associated with diabetes itself.5
The study is a randomized, comparative, controlled trial that will evaluate the efficacy of Revita full thickness placental allograft in improving wound closure rates and mean closure time in diabetic foot ulcers (DFUs) as compared to current standards of wound care treatment. The trial will be conducted at primary institutions/centers in the United States. This trial focuses on patients who suffer from Type 1 or 2 Diabetes with diabetic foot ulcer(s) greater than 1cm2 and less than 25 cm2 for longer than 4 weeks prior to enrollment. The target enrollment is 40 patients, and patients will be randomized to either the Treatment or Control group. Additional study outcome measures include time to closure, number of patients with 50% ulcer volume decrease by day 28, and percent healed in the open label phase.
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™, dehydrated cell and protein concentrate (dCPC) injectable, and Revita®, an intact human placental membrane allograft that preserves all layers of the native tissue in a shelf-stable format. These innovative 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.
- American Diabetes Association. Statistics About Diabetes. 2018 Mar.
- Singh N, Armstrong DG, Lipsky BA. Preventing foot ulcers in patients with diabetes. JAMA2005;293:217–228pmid:15644549
- Alexiadou, Management of Diabetic Foot Ulcers. 2012 Apr 20.
- Armstrong DG, Wrobel J, Robbins JM. Guest editorial: are diabetes-related wounds and amputations worse than cancer? Int Wound J 2007;4:286–287pmid:18154621
- Rice, et al. Burden of Diabetic Foot Ulcers for Medicare and Private Insurers 2014 Mar; 37(3): 651-658
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