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Intradiscal rhGDF-5 Phase I/II Clinical Trial

NCT00813813 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2016-02-26

Study results available
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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

Conditions

  • Degenerative Disc Disease

Interventions

DRUG

Intradiscal rhGDF-5

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.

Sponsors & Collaborators

  • DePuy Spine

    lead INDUSTRY

Principal Investigators

  • James Rathmell, MD · Massachusetts General Hospital

  • Richard Guyer, MD · Texas Back Institute

  • Marvin Tark, MD · Drug Study America

  • Jim Youssef, MD · Durango Orthopedic Associates/Spine Colorado

  • Norman Harden, MD · Shirley Ryan AbilityLab

  • Jonathan Borden, MD · Riverhills Healthcare, Inc.

  • Yaoming Gu, MD · Virginia Commonwealth University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-06-30
Primary Completion
2013-06-30
Completion
2013-06-30

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00813813 on ClinicalTrials.gov