A prospective trial of DXM gel for early stage chronic low back pain
Research type
Research Study
Full title
A prospective cohort study to evaluate the safety and efficacy of Gelmetix DXM gel injection into the intervertebral disc in patients with early stage chronic low back pain
IRAS ID
198057
Contact name
Philippe Jenny
Contact email
Sponsor organisation
Gelexir Ltd
Duration of Study in the UK
3 years, 6 months, 3 days
Research summary
Gelmetix Healthcare Ltd. has developed a novel Double Cross Linked hydrogel (DXM), which is inserted in the disc in the spine via a minimally invasive procedure. The Gelexir DXM gel is used for the treatment of Chronic Low Back Pain (CLBP) caused by degenerative disc disease (DDD). The Gelmetix DXM hydrogel is designed to restore the normal dynamic pressure environment within the disc, have a favourable effect on cell biology and ultimately slow down the degenerative process.
The study is designed to evaluate the safety and efficacy of Gelmetix DXM hydrogel for the treatment of discogenic pain associated with degenerative disc disease (DDD) at one level between L2 and S1. Outcome data using standard scoring systems and adverse event records will be compared to published data and will be used to support a CE mark application.
This study will be conducted as a single centre trial at Salford Royal NHS Foundation Trust. 45 patients of both sexes, from 18 to 55 years of age (inclusive) who have provided written informed consent will be recruited into the study. The Gelmetix DXM gel will be administered into the intervertebral disc using a double barrel syringe. The Gelexir DXM injection is performed on an out-patient basis. Evaluations will be made using the Oswestry Disability Index (ODI), Visual Analogue Scale (VAS), SF-12 and EuroQol EQ-5D. MRI scans will also be assessed to evaluate the maintenance of hydration (disc height) after treatment. Data will be collected before, during and after treatment at 7-21 days, 3 months, 6 months, 9 months, 2 and 3 years post-treatment with an option to continue into the longer term. The trial duration is expected to be 3.5 years from first patient in (FPI) to last patient out (LPO).
REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
16/NW/0239
Date of REC Opinion
7 Jun 2016
REC opinion
Further Information Favourable Opinion