REX-001 to treat critical limb ischaemia in adults with diabetes
Research type
Research Study
Full title
The Efficacy and Safety of Intra-Arterial Administration of Rexmyelocel-T to treat Critical Limb Ischemia in Subjects with Diabetes Mellitus: Two Pivotal, Placebo-Controlled, Double-Blind, Parallel-Group, Adaptive Trials
IRAS ID
208292
Contact name
Jill Belch
Contact email
Sponsor organisation
Rexgenero Limited
Eudract number
2016-000240-34
ISRCTN Number
ISRCTN00000000
Duration of Study in the UK
2 years, 9 months, 16 days
Research summary
This is a research study in diabetic patients between the ages of 18 and 80 years that have Critical Limb Ischaemia (CLI) Rutherford Category 4 and Category 5, a condition which reduces blood flow to the arteries of the leg and feet. Pain can occur while at rest and which most often occurs at night, but in severe cases can be continuous and/or when walking. Leg ulcers or gangrene may also be present. The study involves an experimental product called Rexmyelocel-T (a cell therapy produced from autologous bone marrow). All participants will have a bone marrow sample taken and this will be processed in a laboratory. Participants will receive either Rexmyelocel-T or placebo, a look-alike treatment that has no active compound infused into their diseased arteries. The study will last 24 months; after the 12-month follow up visit has been completed for all participants those on placebo will be given the option to receive Rexmyelocel-T. It is hoped Rexmyelocel-T may improve wound healing on the leg, support existing arteries and stimulate the formation of new blood vessels to help improve circulation of blood to the leg, reduce pain and make walking easier. Rexmyelocel-T may help avoid disease progression to extended gangrene or amputation.
REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
16/EE/0412
Date of REC Opinion
5 Dec 2016
REC opinion
Further Information Favourable Opinion