The world’s first clinical trial for the treatment of patients with torn meniscal cartilage using a new type of stem cell bandage has received approval from the Medicines and Healthcare products Regulatory Agency, London. Those with knee injuries could benefit from this treatment if clinical trials are successful.
The Phase I trial will treat meniscal tear patients with a cell bandage product, seeded with the patient’s own, expanded, stem cells. The cell bandage, produced by Azellon Ltd, is focused on the research, development, and commercialization of an adult autologous stem cell technology.
The trial is designed primarily to test the safety profile of Azellon’s cell bandage in ten meniscal tear patients, but some information on whether or not it works will also be obtained.
The bandage, containing the patient’s own stem cells will be implanted in a simple surgical procedure using a specially designed instrument that helps to deliver the cells into the injured site as a first-line treatment in place of removal of the meniscus. Patients will be closely monitored for safety over a 5-year follow-up period.
“The approval we have received from the MHRA is an important milestone in the development of stem cell therapies in the UK,” said professor Anthony Hollander, Chief Scientific Officer at Azellon Ltd and Head of the School of Cellular and Molecular Medicine at the University of Bristol. “These cells hold much scientific and medical promise but we can only know if they work or not by testing them out in clinical trials.”
[Source: University of Bristol]