Retention of CD16+ monocytes in the ischaemic limb
Research type
Research Study
Full title
The Retention of Angiogenic CD16+ Monocytes in Critical Limb Ischaemia (ROAM-CLI)
IRAS ID
137422
Contact name
Bijan Modarai
Contact email
Sponsor organisation
King's College London
Research summary
Peripheral arterial disease affects 20% of individuals over 75. This can lead to critical limb ischaemia (CLI), which manifests as intractable pain, ulceration and gangrene. The quality of life in CLI is similar to terminal cancer. 1/3 of patients cannot be revascularised by conventional treatments and require amputation. Clinical trials using cell-therapy to stimulate blood vessel growth (angiogenesis) have the potential to salvage the limb but have shown modest benefits in man. It is widely acknowledged that the main reasons for this are: (i) cells injected into the ischaemic muscle are lost precipitously and; (ii) the most efficacious cell type to deliver has not yet been determined.
Our preclinical investigations have identified a subset of monocytes expressing the CD16 receptor (CD16+ monocyte) that are particularly effective in stimulating angiogenesiss, which is essential for the restoration of blood flow in the ischaemic limb. We aim to determine (i) the feasibility of isolating CD16+ monocytes from the blood of CLI patients and (ii) The retention of CD16+ monocytes when injected back into the ischaemic limb. These data from the proposed clinical study is essential for developing a novel therapeutic strategy that is more effective than current cell based treatments.
The proposed study is a physiological study to track the fate of CD16+ monocytes following delivery into the ischaemic limbs of 15 patients at Guy’s & St Thomas’ NHS Foundation Trust. We treat over 800 patients a year with peripheral vascular disease and recruitment is, therefore, feasible within the duration of the study.
REC name
London - London Bridge Research Ethics Committee
REC reference
14/LO/0474
Date of REC Opinion
19 May 2014
REC opinion
Further Information Favourable Opinion