Intradiscal rhGDF-5 Phase I/II Clinical Trial

Status:	Completed
Conditions:	Orthopedic
Therapuetic Areas:	Orthopedics / Podiatry
Healthy:	No
Age Range:	18 - Any
Updated:	4/21/2016
Start Date:	June 2008
End Date:	June 2013

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

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

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

We found this trial at

sites

TBI Clinical Research, LLC

Plano, Texas 75093

from

Plano, TX