A 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

This study has been completed.
Sponsor:
Collaborator:
Janssen-Cilag Pty Ltd
Information provided by (Responsible Party):
DePuy Spine
ClinicalTrials.gov Identifier:
NCT01158924
First received: July 1, 2010
Last updated: May 22, 2014
Last verified: May 2014
  Purpose

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


Condition Intervention Phase
Early Lumbar Disc Degeneration
Drug: Intradiscal rhGDF-5
Phase 1
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: A 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

Further study details as provided by DePuy Spine:

Primary Outcome Measures:
  • Evaluate the safety and tolerability of Intradiscal rhGDF-5 in subjects with early lumbar disc degeneration [ Time Frame: Through a 36 month period ] [ Designated as safety issue: No ]
    Clinical outcome measurements and safety outcomes (adverse events, neurological status, and standard laboratory results of CBC, blood chemistry and rhGDF-5 antibody analysis)


Secondary Outcome Measures:
  • Investigate the preliminary effectiveness of Intradiscal rhGDF-5 in subjects with early lumbar disc degeneration [ Time Frame: Through a 36 month period ] [ Designated as safety issue: No ]
    Clinical outcome measurements and safety outcomes (adverse events, neurological status, and standard laboratory results of CBC, blood chemistry and rhGDF-5 antibody analysis)


Enrollment: 40
Study Start Date: March 2010
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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.
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Persistent low back pain with at least 3 months of non-surgical therapy at one or two suspected symptomatic lumbar levels (L3/L4 to L5/S1)

    a. The recruiting physician will use their standard clinical and radiological practice to determine the one/two disc level(s) be treated, i.e., but not limited to a combination of MRI, CT and/or Technetium bone scans, functional x-rays, input from a spinal injection program (targeting facet joints and/or epidural space) and discography (a discogram performed within 12 months of the anticipated study treatment date is acceptable, as long as the subject has not had an accident or re-injury).

  2. Oswestry Disability Index (ODI) for low back pain of 30 or greater
  3. Low Back Pain score greater than or equal to 4 cm as measured by Visual Analog Scale (VAS) at Visit 1 Baseline
  4. Male or Female 18 years of age or older

Exclusion Criteria:

  1. Persons unable to have an MRI
  2. Abnormal neurological exam at baseline (e.g., chronic radiculopathy)
  3. Persons with neurological or radiographic evidence of active radicular pain due to anatomical compression such as stenosis or disc herniation (persons with somatic referred pain are allowed)
  4. Suspected symptomatic facet joints and/or severe facet joint degeneration at the index level(s) or adjacent segments
  5. Suspected symptomatic sacro-iliac joint
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01158924

Locations
Australia, New South Wales
Hunter Clinical Research
Broadmeadow, New South Wales, Australia, 2292
St. George Private Hospital
Kogarah, New South Wales, Australia, 2217
Australia, Queensland
BrizBain & Spine, The Wesley Hospital
Auchenflower, Queensland, Australia, 4066
Sponsors and Collaborators
DePuy Spine
Janssen-Cilag Pty Ltd
  More Information

No publications provided

Responsible Party: DePuy Spine
ClinicalTrials.gov Identifier: NCT01158924     History of Changes
Other Study ID Numbers: 09-Intradiscal rhGDF-5-02
Study First Received: July 1, 2010
Last Updated: May 22, 2014
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Additional relevant MeSH terms:
Intervertebral Disc Degeneration
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases

ClinicalTrials.gov processed this record on October 29, 2014