Regenerative medicine start-up Upside Biotechnologies has signed a Cooperative Research and Development Agreement (CRADA) with the US Army Medical Research and Materiel Command (USAMRMC) based in Fort Detrick, Maryland.
The CRADA initiates a collaboration on both the scientific and regulatory aspects of Upside’s engineered skin product development.
New Zealand-based Upside is developing an advanced, world-class skin replacement treatment for patients suffering major burns.
This regenerative medicine company’s technology enables a small sample of unburnt patient skin to be grown in the laboratory into large areas of full thickness skin.
This lab-grown skin can be used as skin grafts in patients with major burns who do not have enough uninjured skin to provide conventional skin grafts.
Upside skin is produced faster than any competitive product in development. It is supplied in larger sheets with handling characteristics preferred by burns surgeons.
Upside CEO Dr. Robert Feldman says the USAMRMC has an unparalleled depth of experience in the development and treatment of major burns.
“This US Army input will be hugely valuable to Upside and will fully assist us in successfully progressing our product to the benefit of all burn sufferers, including US warriors,” Dr. Feldman says.
“The USAMRMC is pleased to provide guidance to Upside Biotechnologies as it navigates the US FDA approval process for a novel skin replacement product,” says Susan Taylor, product manager for the Tissue Injury and Regenerative Medicine Project Management Office at the US Army Medical Materiel Development Activity, USAMRMC.
“This product may provide a critical solution in the treatment of service members who have sustained severe burns. Our goal is to help Upside move this product as quickly and as safely as possible through the regulatory process, so it is available to our wounded service members.”
Upside uses a combination of a proprietary, specially-designed culture chamber with methods for speeding cellular growth to achieve its superior product.
The skin is grown on a mesh that confers superior handling.
The 12-step technology and process for culturing the companies engineered skin product is as follows:
- Digest cells from a sample of skin
- Culture cells in flasks
- Transfer skin cells from flasks to Upside’s culture chambers
- Seal chambers
- Cells attach to coated synthetic mesh held on frame (orange in diagram)
- Turn over chambers
- Frame holding mesh and cells falls to bottom
- Cells are now next to a gas permeable membrane
- Gas passing through membrane gives signal for epithelial cells to differentiate
- Skin ready to be transported to patient in same chambers
The US Army Medical Research and Materiel Command is the Army’s medical materiel developer, with responsibility for medical research, development, and acquisition and medical logistics management.
The USAMRMC’s expertise in these critical areas helps establish and maintain the capabilities the Army needs to fight and win on the battlefield.