CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 40 enrolled
Drug / intervention
Intradiscal rhGDF-5drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01158924
NCT01158924Phase 2Completed
CompareCT.gov

A Phase I/IIa, Multicenter, Open-label, Clinical Trial to Evaluate the Safety, Tolerability and Preliminary Effectiveness of Single Administration Intradiscal rhGDF-5 for the Treatment of Early Stage Lumbar Disc Degeneration

DePuy Spine·interventional·Posted Jul 8, 2010·Updated Feb 26, 2016

In Brief

A Phase 2 clinical trial evaluating Intradiscal rhGDF-5 for Early Lumbar Disc Degeneration. Completed, enrolled 40 participants across 3 sites.

Detailed Summary

Study to show the safety, tolerability and preliminary effectiveness of Intradiscal rhGDF-5 in subjects with early lumbar disc degeneration.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEarly Lumbar Disc Degeneration
CountriesAustralia
CollaboratorsJanssen-Cilag Pty Ltd

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJul 8, 2010
Enrollment StartMar 1, 2010
Primary CompletionMar 1, 2014
TodayJul 2, 2026
Enrollment to primary: 4 yearsPosted 16.0 years ago

Interventions

Intradiscal rhGDF-5drug

The API is recombinant human growth and differentiation factor-5 (rhGDF-5), a recombinant version of human GDF-5. GDF-5 is a member of the transforming growth factor-b (TGF-b) superfamily and the bone morphogenetic protein (BMP) subfamily, and is known to influence the growth and differentiation of various tissues, including the intervertebral disc. In vitro experiments have shown that rhGDF-5 can stimulate gene expression and synthesis of the extracellular matrix proteins type II collagen and aggrecan. In vivo experiments in rabbit models of disc degeneration have shown that intradiscal injections of rhGDF-5 can stimulate an increase in disc height and hydration.