StimLabs, a provider of regenerative technologies and products, has enrolled first patient in its trial designed to assess the safety and efficacy of Revita human placental graft in diabetic foot ulcers (DFUs).
Image: StimLabs has started Revita human placental graft trial in diabetic foot ulcers. Photo: courtesy of rawpixel / Unsplash.
Revita is said to be the first amniotic placental membrane allograft to capture the complete intact membrane in a shelf-stable format.
The multi-center randomized, comparative and controlled trial will assess the efficacy of Revita full thickness placental allograft in improving wound closure rates and mean closure time in DFUs compared against current standards of wound care treatment.
StimLabs is carrying out the trial at primary institutions/centers in the US. The trial includes patients who suffer from type 1 or 2 diabetes with DFUs greater than 1cm2 and less than 25 cm2 for longer than four weeks prior to enrollment.
The company intends to recruit 40 patients in the trial, and they will be randomized to either the treatment or control group.
Revita’s 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.
The patent-pending Clearify process has been used to processs Revita to preserve all three layers of the biologic tissue and maintain the physiologic 3D architecture of the natural barrier membrane.
The Clearify process enables to eliminate unwanted constituents from the placental membrane and yield a safe sterile product.
StimLab founder and CEO John Daniel said: “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.”
Established in 2015, StimLabs has introduced a suite of amniotic-derived products and developed a product pipeline across a range of clinical applications.