Efficacy study of CTX0E03 injected into the brain of stroke patients
Research type
Research Study
Full title
A Phase II Efficacy Study of Intracerebral CTX0E03 DP In Patients with Stable Paresis of the Arm Following an Ischaemic Stroke.
IRAS ID
118562
Contact name
Keith Muir
Contact email
Sponsor organisation
ReNeuron Ltd
Eudract number
2012-003482-18
Clinicaltrials.gov Identifier
Duration of Study in the UK
4 years, 1 months, 0 days
Research summary
In the UK, around 150,000 people suffer a stroke every year and a quarter of a million adults live with long-term disability as a result of stroke. The majority of strokes (80%) are termed “ischaemic”. An ischaemic stroke is caused by an interruption of blood flow to the brain resulting in cell death and damage. Following a stroke, most people experience at least some degree of recovery in the first 6 months, most rapidly and largely defined in the first few weeks. However, up to 30% of patients are left with persistent disability of some degree. Recovery after a stroke involves rehabilitation strategies such as physiotherapy. At present, there are no medical treatments that can repair the brain damage caused by a stroke.
This study involves an injection into the brain of human neural stem cells (CTX0E03 DP). The study follows on from a previous study which was designed to assess the safety of different doses of CTX0E03 DP in ischaemic stroke patients (2, 5, 10 and 20 million cells). This new study will continue to assess safety, however it will also assess the “efficacy” of CTX0E03 DP i.e. to see if the cells have an effect on disability. All participants in the study will receive the 20 million cell dose of CTX0E03 DP, to determine if this dose should be developed further as a potential treatment for stroke disability. The study will enrol at least 21 patients who have suffered a stroke between 2 and 10 months prior to CTX0E03 DP treatment.
Participants will be assessed over a 1 year period using standard stroke assessment questionnaires and scales, after which they will be monitored for life using a NHS central register.
REC name
London - West London & GTAC Research Ethics Committee
REC reference
13/LO/1174
Date of REC Opinion
24 Sep 2013
REC opinion
Further Information Favourable Opinion