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Muscle Regeneration for Incontinence

Incontinence is a significant unmet clinical need. Cell therapy offers a promising solution to restoring the function of muscles that provide continence. Early clinical studies have reported mixed results, with some studies showing no improvement in muscle function. This is likely due to the cells being delivered in a sub-optimal condition due to their manipulation outside the body and delivery as a suspension, an unnatural state for a muscle cell.

To address this, we are developing highly porous biodegradable TIPS microcarriers that are used as a substrate to grow patients' own muscle progenitor cells (myoblasts) in vitro, before delivering them, still anchored to microcarriers, into the defective muscle. The microcarriers are designed to slowly degrade as the myoblasts integrate with the host muscle, forming new functional tissue that will restore continence.

We are evaluating the beneficial effects of delivering cells attached to the microcarriers compared with conventional delivery methods.

People involved:

Professor Richard Day

Dr Alex Popov

Dr Francesco Saverio Tedesco, UCL Division of Biosciences

Dr Daniel Stuckey, UCL Division of Medicine

Professor Charles Knowles, Queen Mary University London

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A Novel Medicial Device for Fistula Repair

Fistulas are abnormal connections between two epithelialized surfaces e.g. blood vessels, bladder, intestines, or other hollow organs. The goal of fistula surgery is to close the fistula whilst trying to avoid damage to the surrounding tissue. A range of materials have been used to fill fistulas in an attempt to promote healing but all of these have failed because the material becomes dislodged and falls out or results in an infection.

We are developing novel highly porous microspheres to overcome this problem. When packed into a fistula the microspheres provide a 'scaffold' that cells can easily grow between and into. As the microspheres slowly dissolve they are replaced by new tissue.

Funding from the Wellcome Trust has enabled GMP scale-up of our manufacturing process and testing of the microspheres as a class III medical device (the highest classification for a medical device covering high-risk products that require the greatest level of assessment) in a phase I/II first-in-man clinical safety study at UCL H.

The microspheres are UCL's first biomaterial for regenerative medicine granted approval for clinical use in a regulated device trial by the Medicines and Healthcare Products Regulatory Agency (MHRA).

People involved:

Dr Richard Day

Dr Dan Fullen, UCL Translational Research Office

Mr James Crosbie, University College London Hospital

Dr David Brealey, University College London Hospital

Dr Rachel Evans, University College London Hospital

Professor Charles Knowles, Queen Mary University London