Pioneering stem cell bandage receives UK approval for clinical trial
Press release issued: 6 June 2011
Millions of people with knee injuries could benefit from a new type of stem cell bandage treatment if clinical trials are successful. The world’s first clinical trial for the treatment of patients with torn meniscal cartilage has received approval from the UK regulatory agency, the MHRA, to commence. The current treatment for the majority of tears is the removal of the meniscus, a procedure that often results in the early onset of osteoarthritis.
Millions of people with knee injuries could benefit from a new type of stem cell bandage treatment if clinical trials are successful. The world’s first clinical trial for the treatment of patients with torn meniscal cartilage has received approval from the UK regulatory agency, the MHRA1, to commence. The current treatment for the majority of tears is the removal of the meniscus, a procedure that often results 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 own, expanded, stem cells. The cell bandage, produced by Azellon Ltd, a University of Bristol spin-out company, is focused on the research, development and commercialisation of an adult autologous (patient's own) stem cell technology which in vitro (tissue culture) has shown great promise for the healing of meniscal tears.
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 five-year follow-up period.
Professor Anthony Hollander, Chief Scientific Officer at Azellon Ltd and Head of the School of Cellular and Molecular Medicine at the University of Bristol, said: “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.”
Professor Ashley Blom, Professor of Orthopaedic Surgery at the University of Bristol, added: “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.”
More than 900,000 patients have meniscal tears every year in Europe with perhaps 800,000 to one million meniscal repairs in US making the total market 1.7 million meniscal tears per year. Seven per cent of meniscal surgeries are repairs in the ‘red’ zone, the rest (1,581,000 tears) remain total or partial menisectomies. Meniscus tears normally occur in active and younger people (estimated 80 per cent of meniscal patients are younger than 50). Meniscus tear is a common sports injury and is especially prevalent amongst competitive athletes in football (including US and Australian rules), rugby and basketball. Patients who have partial or total menisectomy have an increased risk of developing osteoarthritis over the following 4.5 to eight years.
1. Medicines and Healthcare products Regulatory Agency (MHRA)
The MHRA is responsible for the regulation of medicines and medical devices and equipment used in healthcare and the investigation of harmful incidents.
2. Azellon Ltd
Azellon is a spin-out company from the University of Bristol focused on the research, development and commercialisation of an adult autologous (patient's own) stem cell technology which in vitro (tissue culture) has shown great promise for the healing of meniscal tears. http://www.azellon-ltd.com/
Azellon Ltd is now developing the first commercially practical applications of that same fundamental technology to create ‘cell bandages’ that can be transplanted into a damaged knee meniscus, helping to regenerate the joint, and saving the patient from future surgery and potentially debilitating osteoarthritis.
3. Professor Anthony Hollander, Chief Scientific Officer and co-founder of Azellon Ltd
Professor Anthony Hollander is based in the Department of Cellular and Molecular Medicine at the University of Bristol. Professor Hollander came to national prominence as part of the academic team that saved the life of Claudia Castillio, after developing the first tissue-engineered trachea (windpipe) using the patient’s own stem cells. This fully functioning airway was transplanted into the patient and saved her life.
4. What is meniscal tissue?
All joints have a thin layer of cartilage at the ends of the bones where they meet each other to prevent the bones from fracturing and to allow a smooth movement of the joint. However the knees have, in addition, two semi-lunar shaped pieces of fibrous cartilage called menisci, which act as shock-absorbers.