CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 32 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/NCT00813813
NCT00813813Phase 2Completed
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Phase I/II, Multicenter, Open-label, Single Administration, Dose Finding, Clinical Trial to Evaluate the Safety and Tolerability of Intradiscal rhGDF-5 for the Treatment of Early Stage Lumbar Disc Degeneration

DePuy Spine·interventional·Posted Dec 23, 2008·Updated Feb 26, 2016

In Brief

A Phase 2 clinical trial evaluating Intradiscal rhGDF-5 for Degenerative Disc Disease. Completed, enrolled 32 participants across 8 sites.

Detailed Summary

Study to show the effectiveness and safety of a single injection of rhGDF5 into a degenerating single spinal disc in treating lumbar level degenerative disc disease

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDegenerative Disc Disease
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedDec 23, 2008
Enrollment StartJun 1, 2008
Primary CompletionJun 1, 2013
TodayJul 2, 2026
Enrollment to primary: 5 yearsPosted 17.5 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.