In Situ Terapia Celular, a startup based in Ribeirão Preto (state of São Paulo, Brazil), has developed a biodressing for smart treatment of wounds and burns. The project was supported by FAPESP’s Innovative Research in Small Business Program (PIPE).
Outwardly resembling a contact lens, the biodressing is produced by a 3D bioprinter using stem cells and a hydrogel. It is more effective than currently available alternatives because it can be applied directly to human skin. The firm has filed for approval of the clinical trial and registration of the product by ANVISA, Brazil’s national health surveillance authority.
“When applied to a highly inflamed wound or burn, it inhibits secretion of certain substances involved in the inflammatory process,” says Carolina Caliári Oliveira, the startup’s founder.
The umbilical cord stem cells used in the biodressing have the potential to stimulate skin tissue regeneration. The skin is the largest organ in the human body. “The key innovation in this entire process was integration of the techniques deployed, ensuring that stem cells and biomaterial perform effectively, as demonstrated by laboratory testing,” Oliveira said.
The firm was able to realize its business plan, she added, thanks to the indigenous development of a bioprinter by another Brazilian startup, 3D Biotechnology Solutions, also with support from PIPE-FAPESP (more at: agencia.fapesp.br/32254/).
“This greatly facilitated development of our own product by reducing the cost of the printing process. We wouldn’t be able to import a bioprinter,” Oliveira said.
3D printing has also proved decisive for the firm to plan a future biodressing production line. “We have finished building all the requisite infrastructure,” she said.
Initially, the biodressing will be offered to private hospitals.
According to Oliveira, in addition to the biotech innovation, the product has several competitive advantages over existing biodressings on the market. “Its cost-benefit ratio is outstanding and it is easy to apply,” she said. “Some of the existing dressings are painful. Our biodressing is just placed lightly on the wound. Being highly innovative and entirely indigenous, it’s going to be accessible to patients who need this kind of treatment.”
Chronic wounds in diabetics and patients with bad circulation can lead to amputation of extremities or even a lower member. “Our product could potentially be used by 5 million people in Brazil who suffer from chronic wounds or severe burns,” Oliveira estimated.
She originally set out, in 2016, to develop a personalized cellular therapy, but a course correction proved necessary, as often happens to startups. “We soon realized that developing a personalized cellular therapy wouldn’t lead us to a scalable product like this biodressing, given the use of umbilical cord stem cells,” she recalled.
The startup is developing other products based on the use of extracellular vesicles derived from the production of stem cells in the laboratory.
“We plan to use them in a less complex product such as an ointment that can also help heal simpler wounds or hypertrophic scars [thick raised scars formed as an abnormal response to wound healing due to overproduction of collagen],” Oliveira said.
Featured image: Developed by startup In Situ from stem cells and a hydrogel, the product is bioprinted and placed lightly on the skin (photo: In Situ)
Provided by FAPESP