Intradiscal rhGDF-5 Phase I/II Clinical Trial

• Status: Completed
• Trial end date: 2013-06-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: DePuy Spine

Criteria

Inclusion Criteria:

1. Persistent low back pain, with at least 3 months of non-surgical therapy, at one symptomatic lumbar level (L3/L4 to L5/S1) as confirmed using a standardized discography protocol

2. Oswestry Disability Index of 30 or greater

3. Low back pain score greater than or equal to 4 cm as measured by VAS, at Visit 1 baseline and on day of treatment to confirm eligibility prior to administration

Exclusion Criteria:

1. Persons unable to have a discogram, CT or an MRI

2. Abnormal neurological exam at baseline (e.g., radiculopathy)

3. Radicular pain

4. Leak of contrast agent during the discogram, into the epidural space (does not include leak of contrast agent along the needle track)

5. MRI findings demonstrate any of the following:· Suspected disc appears normal· >50% decrease in disc height· Modic changes, and/or· Presence of osteophytes or significant facet arthrosis