Xintela Granted U.S. Patent for XSTEM Treatment of Difficult-to-Heal Wounds and Skin Defects
The patent strengthens Xintela’s U.S. protection for XSTEM as a regenerative treatment for chronic wounds and skin damage, supported by preclinical results showing improved healing and reduced scarring and by ongoing clinical development in hard-to-heal ulcers and burns.
Key points
- Xintela has received a U.S. patent covering use of its stem cell product XSTEM for skin defects and difficult-to-heal wounds.
- The patent includes chronic wounds, venous and diabetic leg ulcers, pressure ulcers, and methods aimed at reducing fibrosis and scarring.
- Xintela says the patent builds on preclinical wound-healing data and follows a Phase I/IIa study in venous leg ulcers, with additional studies being planned.
Xintela has been granted a U.S. patent for the use of its stem cell product XSTEM for treatment and regeneration of skin defects, including difficult-to-heal chronic wounds. The patent, US 12,599,633, protects XSTEM in the United States until 7 June 2043.
What the patent covers
The patent covers methods for treating and regenerating skin defects, including chronic wounds, venous and diabetic leg ulcers, and pressure ulcers. It also covers prevention of skin fibrosis and reduction of scar formation. The patent was developed in collaboration with Professor Folke Sjöberg and colleagues at Linköping University Hospital, who are co-inventors.
Preclinical and clinical work
Xintela’s dermatology program is based on its collaboration with the Burn Centre in Linköping, one of Sweden’s two national burn centres. In two preclinical pig studies, XSTEM showed wound healing with newly formed skin tissue that closely resembled normal skin and less scarring than control, according to the company.
Results from the second study, presented at ISCT Europe 2024, reportedly showed that XSTEM could be detected in newly formed skin tissue two weeks after administration. The company also says XSTEM cells differentiated into skin cells, or keratinocytes, in cell cultures, supporting a regenerative role.
Xintela has also completed a Phase I/IIa clinical study of XSTEM for difficult-to-heal venous leg ulcers. The company is planning additional clinical studies with Linköping University Hospital in other difficult-to-heal wounds, including burns.
“We are very pleased that the USPTO has now granted this patent, which provides important protection for XSTEM in one of the world’s largest pharmaceutical markets. The patent is the result of close and productive collaboration with the Burn Center in Linköping and confirms the strength of our stem cell technology. Difficult-to-heal wounds cause enormous suffering for patients and constitute a significant burden on healthcare systems globally, and we believe XSTEM has the potential to make a real difference for these patients”, says Xintela’s CEO Evy Lundgren-Åkerlund.
Corresponding patent applications are pending or granted in other jurisdictions, including Europe.
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