Researchers at King's have been awarded £2.1m in funding to take a new regenerative, cell-based therapy for leg pain caused by reduced blood flow to clinical trial.
The funding will support a first-in-human study in patients with intermittent claudication, a common and debilitating condition characterised by pain when walking that limits mobility and significantly affects quality of life.
The grant, funded by the Medical Research Council (MRC) Developmental pathway funding scheme (DPFS), will support a 24-participant Phase 1b/2a clinical trial to evaluate the safety and efficacy of the treatment.
Peripheral arterial disease (PAD) affects more than 200 million people worldwide, with intermittent claudication accounting for a large group of patients who continue to have symptoms despite recommended treatment and supervised exercise. While surgical and endovascular procedures, including bypass surgery, angioplasty, or stenting, are effective for advanced cases, these invasive treatments carry a risk of complication, may fail and are often not justified in patients with moderate symptoms. This leaves many patients with limited treatment options and represents a major unmet clinical need.
Led by Dr Ashish Patel, Reader in Vascular Surgery and Sciences and Consultant Vascular Surgeon at Guy's and St Thomas' NHS Foundation Trust, the study will test MON002, an advanced cell therapy generated from the patient's own blood. Monocytes, a type of white blood cell, are collected from the blood and then programmed in the laboratory using clinical-grade mesenchymal stem cells, which are supportive regenerative cells, to induce a phenotype that promotes blood vessel growth. The cells are then injected into the muscle in the affected leg, where they are intended to stimulate remodelling and enlargement of existing blood vessels.
In the study, participants with walking pain and an impaired quality of life will be randomised and receive either a placebo or treatment. They will then undergo regular six-minute walks tests, quality-of-life questionnaires and biomarker analysis to understand how the treatment is affecting them. Those who received the placebo will also be given the opportunity to receive the therapy after the initial stage of the study is completed.
This study targets a group of patients with persistent symptoms and limited effective treatment options. The aim is to generate robust early-phase clinical data to determine whether a regenerative approach can meaningfully improve function and quality of life."
Dr Ashish Patel, Reader in Vascular Surgery and Sciences, King's College London and Consultant Vascular and Endovascular Surgeon, Guy's and St Thomas' NHS Foundation Trust
This award builds on more than a decade of our mechanistic and translational work on monocyte-based therapies in peripheral arterial disease and allows us to take this programme into an early-phase clinical study with a clear route to further development."
Bijan Modarai, Professor of Vascular Surgery, King's College London, Honorary Consultant Vascular and Endovascular Surgeon, Guy's and St Thomas' NHS Foundation Trust and study Co-Investigator
