Cynata Therapeutics Limited announced that it has received approval from the UK Medicines and Healthcare products Regulatory Agency (MHRA) to proceed with its Phase 2 clinical trial of the CymerusTM mesenchymal stem cell (MSC) product CYP-002 in patients with critical limb ischaemia (CLI). CLI is an advanced stage of peripheral artery disease (PAD), which is a narrowing of arteries in the limbs, particularly the legs. The risk of PAD is increased in patients with diabetes, obesity or high blood pressure and also in people who smoke. CLI often results in amputation of the affected limb and is a major risk factor for cardiovascular events such as heart attack. The value of the global CLI treatment market has been forecasted to reach USD 5.4 billion by 2025. As previously announced, in a preclinical study in a mouse model of CLI, treatment with Cymerus MSCs led to significantly higher blood flow in the ischaemic limb and protection against muscle damage, fibrosis, and limb loss.