Stem cell trial for osteoarthritis launched
pharmafile | July 13, 2010 | News story | Research and Development | Arthritis Research UK, Stem cells, osteoarthritis
Stem cell therapy is to be used to treat patients with osteoarthritis in a new UK clinical trial.
Medical research charity Arthritis Research UK is funding a trial to test the effectiveness of stem cells derived from bone marrow (also known as mesenchymal stem cells) at repairing worn cartilage in osteoarthritis of the knee.
The trial will test out stem cells as well as cultured cartilage cells (chondrocytes) to see which is the most effective in treating osteoarthritis. Chondrocytes are currently used to repair small areas of cartilage damage, but not osteoarthritis. These cells are extracted from patients, grown in the lab and re-implanted back into the patient.
A combination of both types of cells will also be trialed with the aim of repairing damage to the joint, stopping osteoarthritis getting worse and delaying or even avoiding the need for knee replacement surgery.
Up to 70 people with established knee osteoarthritis will take part in the year-long trial, scheduled to start by the end of 2010, to be run at the Robert Jones and Agnes Hunt Orthopaedic Hospital in Oswestry, Shropshire, as part of a five-year £500,000 research programme.
The hospital has been at the forefront of using a surgical technique originally pioneered in Sweden called autologous chondrocyte implantation (ACI) using engineered cartilage cells taken from patients with cartilage problems – usually caused by sports injuries – for many years. They have also been using stem cells from bone marrow to repair fractured bone for the past four years.
But now a team led by scientist Sally Roberts, Professor of Orthopaedic Research, and James Richardson, Professor of Orthopaedic Surgery, whose academic base is at Keele University, are optimistic that the procedure of cartilage regeneration produces sufficient amounts of robust new cartilage cells for the technique to be extended to patients with osteoarthritis.
Stem cell transplantation surgery involves two operations and a period of six month’s convalescence and rehabilitation. In the first operation, a patient’s own cartilage or bone marrow stem cells are removed via keyhole surgery, and grown in the lab for three weeks. They are then re-implanted back into the area of damaged or worn cartilage where over several months they form new cartilage. The Oswestry team will follow up the patients for a year, and will look at the quality of the cartilage, and the patient’s ability to perform everyday activities.
Professor Richardson said the study offered a real chance to help osteoarthritis patients, for whom there is currently little effective treatment, apart from joint replacement.
“It’s great that Arthritis Research UK is funding this work in Oswestry to take things further. We are the first laboratory in the UK producing mesenchymal stem cells and chondrocytes for treating patients, so we are unique in being able to test the effectiveness of both types of cell therapy,” he added.
However, Professor Roberts warned that stem cells therapies, although promising, were not the answer to all health problems. “Stem cells are portrayed as ‘wonder cells’ that can do anything, but they can’t give you the joints of a 15 year old,” she said.
“At the moment they are not the ‘magic bullet’ and they don’t solve the underlying problem of osteoarthritis, which still needs to be addressed. They have been hyped up. They certainly have huge potential – we just need to learn how to harness it properly.”
Professor Richardson added: “The important thing is to run a randomised trial. If successful, we need to find out if it is cost-effective. If a few years can be saved, the benefit to the patient may be not to prevent the need for a joint replacement, but to prevent need for a revision of a joint replacement.”
The investigators stressed that the use of stem cell therapies to treat osteoarthritis is still experimental, and that routine clinical use is probably still several years away. Arthritis Research UK is planning to open a new national tissue engineering centre to focus research in this important area within the next 12 months.
Patients taking part in the trial will be recruited from orthopaedic departments from around the UK, on the advice of the local specialist.
Arthritis Research UK is funding the study over five years. As well as running the clinical trial, scientists will seek a better understanding of the biology of repair of ACI by studying biopsies of the repair tissue formed after surgery.
Andrew McConaghie
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