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Intervertebral DXM Gel Injection in Adults With Painful Lumbar Degenerative Disc Disease — DXM gel  

Degenerative Disc Disease Clinical Trial

Official title:
First-in-human Pilot Study for the Safety Assessment of DXM Gel in Patients With Painful Lumbar Degenerative Disc Disease

Clinical Trial Summary

The purpose of this study is to assess the safety and the efficacy of an hydrogel (double cross-link microgel - DXM) injection into the intervertebral disc (IVD) space in patients with painful lumbar degenerative disc disease (DDD) over 24 to 48 weeks.

Clinical Trial Description

After being informed of the study and the potential risks, all patients matching the eligibility criteria and who have given their written consent will undergo a gel injection at day 0 after a period of screening of up to 14 days. Then, they will be followed-up for a variable period according to the cohort : - first cohort of 5 patients with only one disc to be treated will be followed during 48 weeks, - second cohort of 5 patients with 2 discs to be treated will be followed during 36 weeks, - third cohort of 10 patients with 1 or 2 discs to be treated will be followed during 24 weeks. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04727385
Study type Interventional
Source Gelmetix
Contact David Goldsmith, Pr
Phone +44 (0)1625 238 603
Email contact@gelmetix.com
Status Recruiting
Phase N/A
Start date September 15, 2020
Completion date October 2021
View Details
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