Allogeneic Chondroprogenitor Therapy (Phase II) (ACT2)

In the UK, approximately 4.11 million people have knee osteoarthritis (OA). Consequently 98,147 total knee replacements were performed in 2016 costing £510 million, a rise of 33% in 6 years. Around 10-16,000 people require treatment for cartilage defects every year, which if untreated, can progress to OA. With effective early treatment, OA could be prevented.

The National Institute for Clinical Excellence (NICE) have stated that the most cost-effective treatment for cartilage repair is autologous chondrocyte implantation (ACI). ACI is a 2-stage process used to treat cartilage defects in the knee: an initial knee arthroscopy (key-hole surgery) is performed and a cartilage biopsy obtained. The patient's own (autologous) cartilage cells (chondrocytes) are then extracted from the biopsy and grown in the laboratory. The cells are implanted in the cartilage defect at a second surgery ~4 to 6 weeks later. NICE approved ACI in Oct-17, but there has been little adoption by NHS centres due to the regulatory constraints and challenges of an autologous product.

Chondrocytes typically do not multiply in the body and when made to do so in the lab can lose their ability to produce cartilage, one potential reason for some ACI failures. However, there is a subpopulation of cells in cartilage called Chondroprogenitors (CPs) which behave more like stem cells and have the ability to be multiplied many times over without affecting their function. We plan to use donated cartilage tissue from organ donors to obtain CPs, which will then be multiplied and implanted into cartilage defects in a single surgery. Consequently, many patients could be treated from a single donor. This could streamline NHS adoption, improve patient access & reduce morbidity in a more cost-effective way compared to standard ACI.

Key objectives of the project are:
1: Optimise CP manufacture process: Initially we will establish a safe and effective supply of donor cartilage from NHSBT. The current...