This is a guest post by Elizabeth Scanlan.
A large-scale clinical trial across six European countries will this year begin to test the use of adult stem cells as a treatment for knee osteoarthritis.Professor Christian Jorgensen of the University Hospital Montpellier in France, who is sponsor of the trial, said “Ambitious as it sounds, we are aiming to deliver an effective treatment for the debilitating and incurable condition of osteoarthritis within as little as five years,“ according to a National University of Ireland Galway press release.
Osteoarthritis is a painful condition that affects over 70 million Europeans, causing individual physical impairment and burdening healthcare resources. Currently there is no treatment that alters its progression and many patients undergo total joint replacement surgery. In the trial, called ADIPOA2, patients who have not responded to standard therapy will be treated with stem cells derived from their own fatty tissue.
Adipose tissue is taken from patients’ abdomens using a minimally invasive liposuction procedure. This tissue is processed and the cells (termed adipose derived mesenchymal stromal cells) are grown, harvested and prepared for injection. Patients are injected with stem cells originating from their own tissue samples and subsequent assessment for pain, stiffness and physical functioning is compared with results from patients treated with a placebo.
An earlier ‘first in man’ trial ADIPOA1, completed at the end of 2014, established the safety of adult stem cells in this context and gave promising indications that the treatment improved pain and joint function. This second, more extensive project builds on the earlier work and aims to further confirm safety, determine whether the treatment provides statistically significant improvement in patient condition and improve understanding of how adult stem cells work at the molecular level.
“From our perspective rigorous, objective and definitive proof about stem cell therapies can only emerge from carefully conducted, well-controlled, multicentre clinical trials. We do not make any claims that are not based on strong evidence. We also work in a fully regulated environment and would only seek to provide these treatments to patients with approval from national and Europe-wide regulatory authorities. Every stem cell treatment should have the same conditions attached,“commented Professor Frank Barry, the coordinator of the project from the Regenerative Medicine Institute (REMEDI) at the National University of Ireland Galway.
“This is a significant project for many reasons,” Christoph Schuhmacher, Clinical Operations Director at the European Clinical Research Infrastructure Network (ECRIN) said, “primarily, it will advance regenerative medicine by providing validated clinical data to the field, but it will also coordinate consistent production of high-quality stem cells in multiple centres and look at the stem cell mechanism of action.”
ECRIN is involved in project, regulatory and data management for the trial, facilitating cooperation across multiple countries.
The trial will be carried out in ten hospitals and involve 150 patients. Eighteen partners from Ireland, France, the UK, Germany, Italy and the Netherlands will participate. Professor Frank Barry from the Regenerative Medicine Institute (REMEDI) at the National University of Ireland Galway is coordinating the project and the University Hospital, Montpellier is the sponsor. This project has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement number 643809.