PLX-CLI-03_PACE_Ph3 IM PLX-PAD in Patients with Critical Limb Ischemia
Research type
Research Study
Full title
A Randomized, Double-Blind, Multicenter, Placebo-Controlled, Parallel- Group Phase III Study to Evaluate the Efficacy, Tolerability and Safety of Intramuscular Injections of PLX-PAD for the Treatment of Subjects with Critical Limb Ischemia (CLI) with Minor Tissue Loss who are Unsuitable for Revascularization
IRAS ID
215985
Contact name
Robert Hinchliffe
Contact email
Sponsor organisation
Pluristem Ltd.
Eudract number
2015-005532-18
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
This study is looking at Critical Limb Ischaemia (CLI), a disease caused by a severe obstruction of the blood flow in the arteries of the leg.
Currently there are no guidelines or approved medical treatment to improve blood flow caused by this type of condition. Treatment modalities for pain relief such as spinal cord stimulation or sympathectomy are controversial.
The standard medical care for patients include anti-platelet drugs (medications against blood clotting) and lipid lowering drugs (statins) that aim to relieve the manifestations of the disease. Drugs called prostaglandins have been suggested to improve the pain, wound healing and possibly to reduce the need for amputations in patients unsuitable for surgery in other clinical trials. However, data is still controversial and these drugs are not yet recommended to treat CLI.
This study is designed to find out if the study drug PLX-PAD is safe and efficient for treatment of CLI in patients for whom surgery or an invasive procedure for restoring the blood flow to the leg are either impossible or judged to be at high risk of failure or complications. Patients will receive either PLX-PAD or placebo in a 2:1 ratio respectively.
The study will take place in 40 sites in total across Germany, UK, US, Czech, Austria, Poland and Hungary with a target of 246 patients to be recruited. 3 sites in the UK have been selected and 10 patients will be recruited. The selection of more UK sites may be planned later in the year. The study will last for approximately three years. This includes the recruitment period.REC name
South Central - Oxford A Research Ethics Committee
REC reference
17/SC/0035
Date of REC Opinion
23 Jun 2017
REC opinion
Further Information Favourable Opinion