A study assessing the safety of an innovative medical device invented by a UCL researcher as a potential treatment for perianal fistulas has launched.
Perianal fistulas are a connection between the anal canal and the skin surface creating an abnormal passageway for the discharge of bodily fluids. Some fistulas can be treated with an operation to cut them open. However, this is not possible for many fistulas because the muscles that provide bowel control can be damaged.
This study will use a new wound filler called TIPS microspheres, invented by BRC supported Dr Richard Day from the UCL Division of Medicine. TIPS microspheres are tiny beads the size of a sugar grain that are intended to help wounds to heal. They are made from a material similar to that used for dissolvable stitches and so naturally dissolve inside the body over time.
When packed into a fistula the microspheres should provide a ‘scaffold’ structure that cells can easily grow between and into. As the microspheres slowly dissolve they are replaced by new tissue.
As a first in man feasibility study, the aim of this clinical trial is to demonstrate that the microspheres are safe when implanted into perianal fistulas in humans. Further studies are planned that will evaluate the use of TIPS microspheres for other types of fistula and applications involving drug or cell delivery.
This pioneering study is the first regulated device trial at the UCLH/UCL Joint Research Office to be performed to ISO14155 compliant Standard Operating Procedures. The study will involve 15 participants at UCLH and is sponsored by UCL with funding from the Wellcome Trust.