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Full thickness skin regeneration is a thing thanks to a new FDA-registered product being developed by PolarityTE.

PolarityTE is testing the only FDA-registered product capable of regenerating full-thickness skin

Regenerative medicine and tissue engineering are hot-topic terms that clinicians and scientists love to throw around in tandem. According to the Association for the Advancement of Blood and Biotherapies (AABB), regenerative medicine may be defined as replacing or “regenerating” human cells, tissues, or organs to restore or establish normal function. Tissue engineering, per the National Institute of Biomedical Imaging and Bioengineering, refers to combining scaffolds, cells, and biologically active molecules into functional tissues to assemble functional constructs that restore, maintain, or improve damaged tissues or whole organs.

Though there is much excitement around the proposed ability to grow new organs and tissues from engineered constructs for direct patient care, the reality is that we are still trying to understand many of the mechanisms that could make this technology more realistic and accessible. A vast group of biomedical researchers across many disciplines are actively working—and have been for decades—to try and solve these mechanistic dilemmas and bring the best possible outcomes to patients in need. 

One area of particular interest in regenerative medicine applications is cutaneous (skin) wound healing. Millions of people worldwide suffer from debilitating, and sometimes fatal, 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 that wreak havoc on the patient’s body while promoting necessary reparative immune cells to the site of injury to promote healing. 

While great strides have been made in recent years, we are still falling short in the clinic with these patients. PolarityTE, headquartered in Salt Lake City, is trying to change that. 

The team at PolarityTE is putting their efforts (and financing) to the test with multi-center clinical trials to test their skin regenerative platform, SkinTE—the only FDA-registered product capable of regenerating full-thickness skin with all layers and appendages. Treatment with SkinTE has also produced function and histology comparable to native skin while limiting contracture, which may improve quality of life. The platform functions by processing a small, full-thickness tissue sample from a patient before engineering a tissue product to be applied to the same patient, allowing for a fully autologous (self-with-self tissue) reconstruction.

“It is estimated that approximately 1 percent of the western population will be affected by venous leg ulcers (VLUs) in their lifetime,” says PolarityTE’s chief scientific officer Nikolai Sopko. “The incidence and prevalence of VLUs continue to increase with an aging population. We believe that these data strongly support the potential of SkinTE to deliver meaningful and positive outcomes for VLU patients and their healthcare providers who are seeking solutions to these highly prevalent and debilitating wounds.”

SkinTE is PolarityTE’s first regenerative tissue product and is now on an open investigational new drug application (IND) with the US Food and Drug Administration. PolarityTE is currently pursuing the first of two pivotal studies on SkinTE needed to support a biologics license application (BLA) for a chronic cutaneous ulcer indication. This is an exciting advancement, as it allows PolarityTE to commence pivotal Phase 3 trials for their SkinTE product in chronic cutaneous 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,” says Richard Hague, president and CEO of PolarityTE. “It is important to note that our strategy to pursue a complex chronic cutaneous ulcer indication, which includes the most challenging and cost-intensive wounds, is based on the learnings from our prior commercial experience as a 361 HCT/P and from our previous non-IND [diabetic foot ulcers] DFU and [venous leg ulcers] VLU [randomized control trials] RCTs, which gives us a great deal of confidence as we look forward to commencing our first pivotal study in the very near future.”

Should this technology prove successful in these longitudinal, multi-center trials, SkinTE could provide a viable, safe solution for patients to directly apply tissue engineering and regenerative medicine innovation very soon—something that many have thought is still years away from reality. This would be a significant step forward for the field and would hopefully inspire similar advances in overlapping applications by harnessing the patient’s body’s ability to safely and effectively self-regenerate.

Jeremie is an experienced MedTech and healthcare consultant, research scientist, entrepreneur, and clinician-in-training. He is passionate about identifying clinical shortcomings and developing patient-centered solutions through novel therapeutic approaches, healthcare delivery optimization, and translational research innovation.