To perform clinical trials in humans with culture-expanded and minimally manipulated cell therapy
This work package aims to focus on treatments for early arthritis in humans, by conducting clinical trials. The trials so far use cells from a patient and grow them in a laboratory and then return a higher number of cells into the disease area. We are using cartilage cells (chondrocytes), bone marrow cells (stem and stromal cells) and cells from fat (stem and stromal).
This type of clinical trial work allows the opportunity to collect the results or outcome of each new treatment and determine how it can be improved upon.
The trials allow not only for the collection of patient outcome but also images and tissue that can be analysed in great detail, which is the purpose of work packages 1 and 3. In this way we can gain a better understanding of disease and so how to direct the best approaches to be taken in the future.
In more detail
Cartilage cell (chondrocyte) implantation is known to reduce pain and improve knee function when implanted into areas of damaged knee cartilage.
The ASCOT trial aims to see if bone marrow-derived stromal cells (containing stem cells, known as BMSCs) will be able to repair this damage better than cartilage cells, or if a combination of BMSCs and cartilage cells is better.
To date we have enrolled over 70 participants into the study, of an overall target of 114. The participants do not know which type of cells have been implanted. All participants are seen by the consultant surgeon and the research nurse at 2 months (24 participants to date), 12 months (2 participants to date) and 15 months after their surgery. A series of assessments are used to monitor their progress, including measures of pain and function, MRI and CT scans to look at the structural quality of the regenerated cartilage, biopsies of repair cartilage will be collected during follow-up keyhole surgery to look at the type of cartilage formed, and recording of any side effects experienced.
A number of laboratory-based studies are running alongside the clinical aspects of the study. These will investigate the biological processes of the repair, look into identifying predictors of success or failure of the treatment, and assess the characteristics and genetics of both cell types.