Research led by Professor Eileen Ingham has revolutionised bioprocesses in the manufacture of tissue scaffolds.
These can be used in the treatment of injuries to the anterior cruciate ligament (ACL) in the knee and offer potentially better outcomes for patients.
A clinical need for a more effective process
Treating injuries to ACL currently requires transplants from healthy tendons elsewhere in the patient’s body or the use of tissue from a deceased donor. This can cause problems in the area of body providing the tendon and in the knee itself, because the donated tissue is starved of oxygen during transplantation which can kill the donated cells. Similarly, tissue from deceased donors already contains dead cells. In both cases, this can delay the healing process and recovery time for the patient.
An alternative approach is to strip porcine tendon of its cells to leave a scaffold that can be implanted into the patient, which their own cells can then repopulate. The porcine superflexor tendon is an ideal candidate, with the right length and strength to be used as an ACL replacement.
A bioprocess for removing the living cells was developed and evaluated over a six-month period in sheep, where it showed good functional performance and evidence of regeneration.
The goal was then to understand how variations in the manufacturing process affect the properties of the scaffold, with the aim of developing a product range that could be better matched to individual patient needs.
Translating the process for manufacture
This expertise was transferred to Tissue Regenix Group to inform their manufacturing process of a decellularised porcine tendon implant, OrthoPure XT. The company has conducted a clinical trial of OrthoPure XT in Europe.
It has given us a much deeper understanding of just how we can vary the manufacturing and sterilisation processes so that we can have a more stratified product range available.