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Bellvitge University Hospital has been a pioneer, conducting 11 surgeries to repair the anterior cruciate ligament of the knee with a new technique using decellularized swine tissue to replace the patient’s own tendon, which is currently the standard procedure. This surgery is part of a clinical trial underway in 10 hospitals in Europe (three in Spain, three in the United Kingdom and two in Poland) chosen for their expertise in this type of operation.

The graft was developed by scientists at the Anglo-American company Tissue Regenix, a spin-off of the University of Leeds, and takes tissue from tendons in the hamstrings (the upper rear part of the leg) of pigs and puts it through a decellularization process. This process consists of extracting the DNA and cell material from the animal tissue, leaving an acellular tissue that can support and stimulate regeneration of the new ligament.

The head of this research at Bellvitge, Dr. Gabriel Oliver of the Knee Department in the Orthopedic Surgery and Trauma Unit, explains that swine tissue was chosen because their hamstrings and collagen are the most similar to human tissue. The technique is being applied after scientists showed, in several laboratory and animal studies, that the surgery has a very low risk of rejection.

Dr. Gabriel Oliver sees advantages in this new technique, as it is a way to avoid having to remove the patient’s own tendon. “In this case, the financial cost is zero, but the cost in terms of health is high and can be seen throughout the recovery process. The alternative so far has been samples from bone banks, which is subject to the availability of a suitable donor.” Oliver believes that the new material could be more affordable than the current surgery due to the greater availability of swine tissue, although the extent to which costs would drop is still to be determined.

This specialist also says that patient recovery could be faster and the immediate post-surgery results, for now, are much more positive: less swelling and pain and greater clinical and subjective satisfaction. What remains to be seen is the results of the final recovery. Dr. Oliver is cautious but expects the recovery process to be shortened by as much as two or three months, which would be a success.


Catalan leadership

Bellvitge is leading the clinical trial because the first two interventions took place at this hospital, on 3 December 2015. The first two patients were a 31-year-old man injured while playing football and a 32-year-old woman injured in a ski accident. Since December, nine more surgeries have been done.

With these 11 surgeries, Bellvitge has concluded its participation in the trial, which has a sample of 40 patients and must be multi-center. “We have done the most surgeries and have had the chance to be the first because we coordinated our efforts well and met all the requirements. The other centers began operating January,” explains Gabriel Oliver, who is also the Spanish delegate for the project. The other two centers in Spain are Hospital Clínico San Carlos de Madrid and Hospital Universitario de La Ribera in Valencia, which has already done its first surgery.

The patients participating in the project will be monitored for two years to assess their progress. If the results are good, researchers expect the technique to gain approval by 2017. “In my opinion, although I don’t have the data to back it up, it is highly likely that the project will work and that this operation will become standard practice,” says Oliver.

“This injury affects people who are relatively young and very active, like athletes. Data says between 10% and 30% of patients that undergo this surgery don’t return to the same level of physical activity as before the injury. We hope to improve these figures and I believe this new technique is a good candidate. We’re very excited,” concludes Oliver.

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