Critical limb ischaemia is the severe ‘end stage’ manifestation of peripheral arterial disease and is caused by chronic lack of blood supply to the leg due to obstruction of blood flow in the peripheral arteries. The condition is characterised by pain at rest and lesions of the leg. There are no effective therapeutics and as many as 50% of CLI patients currently have no treatment option other than limb amputation, as surgical re-vascularisation is contra-indicated or ineffective in these patients. These patients also represent the initial target patient population for the Company’s CTX stem cell therapy, which will be administered via straightforward intramuscular injection of the cells.
We have commenced a first clinical trial of CTX stem cell therapy in the UK. This is a 9-patient Phase I dose escalation study in patients with lower limb ischaemia. The straightforward nature of the treatment and design of the initial CTX phase I clinical trial should enable a relatively swift progression into a Phase II study, subject to the Phase I safety end-points being met.
For further information please refer to the clinical trials page.