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

DePuy Synthes

Status and phase: Completed; Phase 2; Phase 1

Conditions: Early Lumbar Disc Degeneration

Treatments: Drug: Intradiscal rhGDF-5

Study type: Interventional

Funder types: Industry

Identifiers

NCT01158924

09-Intradiscal rhGDF-5-02

Details and patient eligibility

About

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

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

40 participants in 1 patient group

Intradiscal rhGDF-5

Experimental group

Description:

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.

Treatment:

Drug: Intradiscal rhGDF-5