Rgenerative medicine and tissue engineering are hot terms that clinicians and scientists love to use in tandem. According to the Association for the Advancement of Blood and Biotherapies (AABB), regenerative medicine can be defined as the replacement or “regeneration” of human cells, tissues or organs to restore or establish normal function. Tissue engineering, according to the National Institute of Biomedical Imaging and Bioengineering, involves combining scaffolds, cells, and biologically active molecules into functional tissues to assemble functional constructs that restore, maintain, or enhance damaged tissues or whole organs.
Although there is a lot of excitement around the proposed possibility of growing new organs and tissues from artificial constructs for direct patient care, the reality is that we are still trying to understand many of the mechanisms that could make this more realistic and accessible technology. A large group of biomedical researchers across many disciplines are actively working — and have been for decades — to attempt to resolve these mechanistic dilemmas and bring the best possible outcomes to patients in need.
A particular area of interest in regenerative medicine applications is skin wound healing. Millions of people around the world suffer from debilitating, and sometimes life-threatening, complex wounds that cannot be effectively closed and treated with surgery alone. Tissue engineering platforms are constantly trying to harness effective constructs to calm the damaging immune cells wreaking havoc on the patient’s body while promoting the repair immune cells needed at the site of injury to promote healing.
Although great progress has been made in recent years, we are still lagging behind in the clinic with these patients. PolarityTE, headquartered in Salt Lake City, is trying to change that.
The PolarityTE team is putting its efforts (and funding) to the test with multi-center clinical trials to test its skin regeneration platform, SkinTE, the only FDA-registered product capable of regenerating full-thickness skin with all layers and appendages. Treatment with SkinTE also produced function and histology comparable to native skin while limiting contracture, which may improve quality of life. The platform works by processing a small, full-thickness tissue sample from a patient before designing a tissue product to apply to the same patient, enabling fully autologous (self-with-self-tissue) reconstruction.
“It is estimated that approximately 1% of the Western population will be affected by venous leg ulcers (VLUs) in their lifetime,” says Nikolai Sopko, scientific director of PolarityTE. “The incidence and prevalence of VLU continue to increase with the aging of the population. We believe these data strongly support the potential of SkinTE to deliver meaningful and positive outcomes for VLU patients and their healthcare providers seeking solutions to these widespread and debilitating wounds.
SkinTE is PolarityTE’s first regenerative tissue product and is currently the subject of an Investigational New Drug (IND) application with the United States Food and Drug Administration. PolarityTE is currently pursuing the first of two pivotal studies on SkinTE required to support a Biologics License Application (BLA) for a chronic skin ulcer indication. This is an exciting breakthrough as it allows PolarityTE to begin pivotal Phase 3 trials for its SkinTE product in chronic skin ulcers.
“The clearance of our IND is a critical milestone for PolarityTE and a testament to the talent and hard work of our entire team,” said Richard Hague, President and CEO of PolarityTE. “Importantly, our strategy to pursue a complex chronic skin ulcer indication, which includes the most difficult and expensive wounds, is based on the lessons learned from our previous commercial experience as 361 HCT/P and our previous non-INDIANA [diabetic foot ulcers] UDF and [venous leg ulcers] VLU [randomized control trials] ECR, which gives us a lot of confidence as we look forward to starting our first pivotal study in the very near future. »
If this technology succeeds in these multi-center longitudinal trials, SkinTE could provide a viable and safe solution for patients to directly apply tissue engineering and regenerative medicine innovation very soon, which many thought was still years away from reality. This would be a significant step forward for the field and hopefully inspire similar advances in overlapping applications by harnessing the ability of the patient’s body to self-regenerate safely and effectively.