Orthobiologics

Stem cell products have the potential to treat many medical conditions and diseases. However for almost all orthopaedic stem cell products there is limited clinical research around effectiveness, and therefore it is not yet known whether there are any benefits in relation to musculoskeletal and orthopaedic conditions — or importantly if such products are safe to use.

Stem cells obtained from processed fat or bone marrow and injected into joints to have a medical (rather than surgical) effect are considered to be a somatic cell therapy and, therefore, are defined as an advanced therapy medicinal product (ATMP).  In the UK, unproven medicines, including stem cell therapies, that do not have Marketing Authorisation can be manufactured under GMP (Good Manufacturing Practice) conditions and supplied legally but they require: 

1. A HTA (Human Tissue Authority) licence to procure cells for therapeutic use and;
2. A MHRA (Medicines and Healthcare products Regulatory Agency) manufacturing licence for unlicensed medicinal products (Specials Scheme) 

In late 2019, the MHRA announced that, in combination with the HTA, they will be commencing a review of the use of bone marrow aspirate and fat cells in orthopaedic procedures. They have invited healthcare providers to contribute to this review. HCA UK fully support this review and hope that it will lead to a safe regulatory framework around the use of advanced orthobiologics, including the use of fat tissue and bone marrow aspirate.

At this time, HCA UK believe that it is not appropriate to undertake either of these procedures without the required HTA and MHRA licensing in place (ensuring all regulatory requirements are met). HCA UK also believe that a robust governance framework should be established in order to deliver an advanced stem cell treatment service for orthopaedic patients seeking regenerative treatments. 

HCA UK continues to deliver Ortho biological treatments which already have clinical evidence around effectiveness including:

Autologous chondrocyte implantation (ACI) is a proven surgical technique where harvested autologous cartilage cells that have been grown in culture and supplied under specific Marketing Authorisation are transplanted to repair symptomatic cartilage defects of the knee (NICE approved – Ref: Technology appraisal guidance [TA477])

Platelet Rich Plasma (PRP) injections which involve the harvesting of autologous whole blood, often performed in the Outpatient Centre. Platelets are separated from other blood cells and their concentration is increased during a centrifugation process. The high concentration of platelets and bioactive factors are re-injected under image guidance into the injury site to promote tissue regeneration, mediated by the release of several growth factors and cytokines stored in the granules of platelets.

PRP is NICE approved for certain conditions such as knee osteoarthritis (Ref: [IPG637]) tendinopathy (Ref: [IPG438]) where clinicians undertaking the procedure make special arrangements  for clinical governance, consent, and audit or research.