Stem Cell Bandage Enters Clinical Trials

Researchers in the United Kingdom have reached a critical milestone in the long-term international effort of bringing stem cell research to practical application. A group of experts will soon begin the world's first clinical trials using stem cell bandages, designed specifically for knee injuries.

At this time, the new medical aids are targeted specifically at patients who suffer from torn meniscal cartilage, a very painful wound affecting a critical cartilage in the knee. If the new approach is successful, then new ways of addressing the condition might become available.

Right now, the most often-used method of treatment is the surgical removal of the meniscus, which is a procedure that significantly boosts sufferers' risk of experiencing an early onset of osteoarthritis.

MHRA1, the UK regulatory agency, has already given its seal of approval for the clinical trials, which may ultimately benefit millions of people suffering from this condition. It will also prevent many from going on to develop osteoarthritis, which carries its own risks.

The cell bandage product that will soon start Phase I clinical trials, will also be seeded with expanded stem cells, collected from the patients receiving the treatment themselves. The bandage is being produced by University of Bristol spin-out company Azellon Ltd.

Adult autologous stem cell, as in cells cultivated from patients themselves, have shown tremendous capabilities in treating meniscal tears inside lab cultures. It now remains to be seen whether the same correlation applies in real-life as well.

Ten meniscal tear patients will be used during the first trials, but experts with the company says that the study is designed to assess the safety of the bandages. Determining whether or not the product actually works or not will be discerned at a later date.

A five-year follow-up effort will monitor the patients, in a bid to determine whether any long-term health effects are produced. If not, then experts will turn their attention to determining the efficiency level of the new bandages, and the improvements that may be needed.

“The approval we have received from the MHRA is an important milestone in the development of stem cell therapies in the UK. 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,” says Anthony Hollander.

The professor is the Chief Scientific Officer at Azellon Ltd., and also the Head of the School of Cellular and Molecular Medicine at the University of Bristol.

“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, adds Ashley Blom.

The expert holds an appointment as a professor of orthopaedic surgery at the University of Bristol. She explains that nearly 1.7 million meniscal tears are registered around the world every year.