Sign up to read this article for FREE!
After signing up, you'll start to receive regular news updates from us.
A Progress Update on ReN009 Stem Cell Therapy for Peripheral Arterial Disease
Want to listen to this article for FREE?
Complete the form below to unlock access to ALL audio articles.
Read time: 1 minute
PAD is a chronic and debilitating disease that progressively restricts blood flow in the limbs, causing cramping, chronic pain and in extreme cases, amputation. PAD is commonly associated with other conditions, including diabetes, obesity and stroke. At least 1 in 20 people over the age of 55 have some degree of PAD and it becomes more common with increasing age.
Pre-clinical efficacy testing of the ReN009 therapy has been conducted in collaboration with Professor Paolo Madeddu, Dr Rajesh Katare and colleagues at the Bristol Heart Institute, University of Bristol, UK.
Dr Katare is today presenting positive pre-clinical efficacy data with ReN009 at the prestigious American Heart Association Scientific Sessions 2010 in Chicago, running from 13-17 November.
In the study to be p resented, which follows on from a series of successful earlier pre-clinical efficacy studies undertaken by the Bristol team, ReNeuron’s lead CTX stem cell line was tested in a recognised diabetic mouse model of hind limb ischaemia. The diabetic mice exhibited a significant and dose-dependent recovery of blood flow to the ischaemic limb, with significantly increased re-vascularisation of the damaged tissue, when treated with the CTX cells.
ReNeuron is developing its ReN009 therapy as an allogeneic (non-patient specific) stem cell treatment for late-stage PAD, or critical limb ischaemia, in diabetic patients for whom PAD is a side-effect of their diabetes. PAD in diabetics is severe and progresses rapidly. Vascular surgery often has a poor outcome in these patients and in severe cases, amputation is the only clinical option available.
ReNeuron’s ReN009 therapy offers the potential to re-build the vasculature in the affected limb, thus restoring blood flow and avoiding the need for amputation in diabetic patients with critical limb ischaemia. In conjunction with its Clinical Advisory Board for ReN009 and its other clinical and regulatory advisers, the Company has established the late pre-clinical development pathway for the ReN009 programme, leading to a proposed multi-centre first-in-man clinical trial planned for early 2012.
The Company has commenced interactions with, and received guidance from, regulatory authorities in both the UK and the US.
The rate-limiting, long-term pre-clinical safety studies required are well underway and will run alongside the remaining pre-clinical studies and cell manufacturing campaign necessary to complete the regulatory data package to be submitted for clinical trial approvals in due course. The Company will provide further progress updates regarding the ReN009 programme at appropriate points in time over the coming year.
Pre-clinical efficacy testing of the ReN009 therapy has been conducted in collaboration with Professor Paolo Madeddu, Dr Rajesh Katare and colleagues at the Bristol Heart Institute, University of Bristol, UK.
Dr Katare is today presenting positive pre-clinical efficacy data with ReN009 at the prestigious American Heart Association Scientific Sessions 2010 in Chicago, running from 13-17 November.
In the study to be p resented, which follows on from a series of successful earlier pre-clinical efficacy studies undertaken by the Bristol team, ReNeuron’s lead CTX stem cell line was tested in a recognised diabetic mouse model of hind limb ischaemia. The diabetic mice exhibited a significant and dose-dependent recovery of blood flow to the ischaemic limb, with significantly increased re-vascularisation of the damaged tissue, when treated with the CTX cells.
ReNeuron is developing its ReN009 therapy as an allogeneic (non-patient specific) stem cell treatment for late-stage PAD, or critical limb ischaemia, in diabetic patients for whom PAD is a side-effect of their diabetes. PAD in diabetics is severe and progresses rapidly. Vascular surgery often has a poor outcome in these patients and in severe cases, amputation is the only clinical option available.
ReNeuron’s ReN009 therapy offers the potential to re-build the vasculature in the affected limb, thus restoring blood flow and avoiding the need for amputation in diabetic patients with critical limb ischaemia. In conjunction with its Clinical Advisory Board for ReN009 and its other clinical and regulatory advisers, the Company has established the late pre-clinical development pathway for the ReN009 programme, leading to a proposed multi-centre first-in-man clinical trial planned for early 2012.
The Company has commenced interactions with, and received guidance from, regulatory authorities in both the UK and the US.
The rate-limiting, long-term pre-clinical safety studies required are well underway and will run alongside the remaining pre-clinical studies and cell manufacturing campaign necessary to complete the regulatory data package to be submitted for clinical trial approvals in due course. The Company will provide further progress updates regarding the ReN009 programme at appropriate points in time over the coming year.
