The world’s first clinical trial for the treatment of patients with torn meniscal cartilage has received approval to commence from MHRA, the UK’s regulatory agency.
The current treatment for the majority of tears is the removal of the meniscus, a procedure that can result in the early onset of osteoarthritis.
The Phase I trial, one of the first in the UK to be approved using stem cells, will treat meniscal tear patients with a cell bandage product, seeded with the patient’s stem cells.
The cell bandage, produced by Azellon, a Bristol University spin-out company, is focused on the research, development and commercialisation of an adult autologous stem cell technology, which in tissue culture has shown promise for the healing of meniscal tears.
The bandage, containing the patient’s stem cells, will be implanted in a 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 then be monitored for over a five-year follow-up period.
Ashley Blom, professor of Orthopaedic Surgery at Bristol University, said: ‘The effective repair of meniscal tears would represent a significant advance in treatment, particularly for younger patients and athletes, by reducing the likelihood of early onset osteoarthritis, and would offer an exciting new treatment option for surgeons.’
According to Bristol University, there are approximately 1.7 million meniscal tears per year in Europe and the US alone.