A Wave of Regenerative Therapies are Being Developed to Treat Patient Needs


Artificial body parts have been around for some time. Patients have access to artificial limbs, hearts, eyes, skin and more thanks to the innovation of biomedical engineers. As technology improves, so do the advancements in these man-made devices.

But there’s a new trend in personalized medicine that is capable of harnessing parts of a patient’s own body, typically with autologous cells, to develop regenerative therapies. Of late there have been a number of companies involved in this groundbreaking area. One of the companies leading the charge is Utah-based PolarityTE. This week the company announced that its preclinical OsteoTE product “regenerated complex, hierarchically-organized, corticocancellous bone within critically-sized bone defects in standard preclinical large animal models.” Not only that, but the company said OsteoTE regenerated bone with function and composition reflective of native bone. The company said this is something that has never been seen before.

OsteoTE uses bone from the patient as a base for its regeneration process. The bone is prepared and used to treat the defect in less than 24 hours, the company announced.

Denver Lough, chairman and chief executive officer of PolarityTE, said the results of the preclinical OsteoTE studies mirror those that were seen with the company’s SkinTE product, which has been designed to regenerate full-thickness, fully-functional skin. Lough said the OsteoTE studies are a confirmation of the company’s platform technologies.

“We believe there are substantial limitations of the existing treatment options across the numerous applications of OsteoTE, including treatment of bone defects and nonhealing bone within craniomaxillofacial, orthopedic, spine, hand, and foot/ankle specialties. We look forward to continued development and commercialization of products that will change the practice of medicine,” Lough said in a statement.

PolarityTE is so confident in the capabilities of OsteoTE that it is planning for an initial limited-market release of OsteoTE in late 2018. PolarityTE said it will target specialty markets in a stepwise fashion, similar to what it did with SkinTE.  Last fall PolarityTE registered SkinTE with the U.S. Food and Drug Administration in order to accelerate commercialization.

PolarityTE’s technology uses parts of the patient’s body to support the regenerative process as opposed to artificially manipulated individual cells. From the healthy autologous tissue, PolarityTE is able to create a “self-propagating product designed to enhance and stimulate the patient’s own cells to regenerate the target tissues.”

PolarityTE is part of a growing number of companies that are developing these regenerative treatments for body parts. Another company nearing what it hopes will be approval from the U.S. Food and Drug Administration is Massachusetts-based Histogenics. The company has initiated a Phase III clinical trial in the United States under a Special Protocol Assessment with the U.S. Federal Drug Administration to study its proprietary NeoCart replacement cartilage technology. Top-line, one-year superiority data is expected to be reported in the third quarter of 2018, followed by a potential Biologics License Application (BLA) filing. If all goes as hoped, Histogenics could launch NeoCart by 2019.

Like other personalized medicine programs, Histogenics’ technology harnesses the body’s own cells to engineer a treatment, in this case, new cartilage that can be surgically placed in a patient’s knee to alleviate knee pain from osteoarthritis. NeoCart is a cartilage-like, tissue-engineered implant created from a patient’s own cartilage cells.

Last year Amgen leaped into the world of regenerative medicine with the intention of developing a complex therapy for lost neuronal tissue due to neurodegeneration and neurotrauma. Amgen forged an agreement with Fortuna Fix to use a patient's own neural stem cells (autologous) produced by direct reprogramming ("drNPCs") in order to replace lost neuronal tissue.

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