RegMed XB stands for Regenerative Medicine Crossing Borders. It is a virtual institute of Dutch and Belgian public (universities and governments) and private (health foundations and companies) partners that will work together to develop regenerative medicine solutions to health challenges. Aart van Apeldoorn (Maastricht University) is involved in RegMed XB as a research leader for the type 1 diabetes moonshot project. By working with Medace he hopes to replace the insulin syringe with his innovative method – a cell container device.
Van Apeldoorn wants to bring a combination of an implant and cell therapy to the market for people with severe type I diabetes. The idea is to use stem cell technology for this purpose. “The Leiden University Medical Center is conducting research into how beta cells can grow from stem cells. The challenge is to get those cells in a better location in the body than in the liver, and somehow protect them against the immune system using a beta cell replacement implant. A kind of plastic housing for the cells. For this purpose, a prototype of the implant must now be developed, in order to be able to carry out the first studies in humans. “I can’t develop that prototype in my research lab at the university. It’s not clean enough there, and it’s not at the right level of quality control.”
In a pressure cooker trajectory of 12 months the team of Aart van Apeldoorn together with the Medace specialists will develop the necessary quality and regulatory documentation as well as translating the production process from lab to cleanroom. The endpoint of this collaboration will be a cell container device produced according to the applicable MDR (Medical Device Regulations) to be used in the clinical trial setting for the treatment of type I diabetes.
Medace’s role is to facilitate logistics, clean rooms and quality systems. “If I had to do all this myself, I could not afford it,” says Van Apeldoorn.