Intradiscal rhGDF-5 Phase I/II Clinical Trial

DePuy Spine32 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Degenerative Disc Disease

Interventions

Intradiscal rhGDF-5DRUG

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

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (8)

Spine Institute

Santa Monica, California, United States

Durango Orthopedic Associates/Spine Colorado

Durango, Colorado, United States

Drug Studies America

Marietta, Georgia, United States

Rehabilitation Institute of Chicago

Chicago, Illinois, United States

Outcomes

Primary Outcomes

Neurological Assessment for Motor Function and Reflexes/Sensory

Neurological Assessment for Motor Function and Reflexes/Sensory- Number of patients with Clinically Significant Abnormal results at 12 months. For Motor Function, Clinically Significant Abnormal results are determined by the surgeon investigator and are further classified by grade: 0= No Movement, 1= Flicker/trace of contraction, 2=Active movement when gravity removed, 3= Active movement against gravity, 4= Active Movement against gravity and resistance. For Reflexes/Sensory, Clinically Significant Abnormal results are determined by the surgeon investigator and are based on exams of the Knee, Ankle, L3-L5 Dermatone, and S1 Dermatome. Tension signs are evaluated with a straight leg raise to determine at which point, if any, sciatic pain occurs.

Time frame: 12 months

Treatment Emergent Adverse Events- Relationship to Study Drug

Number of patients with Treatment Emergent Adverse Events that were designated as related or possibly related to Study Drug.

Time frame: Through a 12 month period and annual telephone contact at 24 and 36 months for subject health status follow-up

Secondary Outcomes

Change in Function Assessed by Oswestry Disability Index Change at 12 Months From Baseline

The Oswestry Disability Index (ODI) is a 10-category (Pain Intensity, Personal Care, Lifting, Walking, Sitting, Standing, Sleeping, Sex Life, Social Life, Traveling) disability measurement scale with a graded response from 0 to 5, with 0 being the best score (no impairment) to 5 being the worst score (significant impairment). ODI score for a subject is calculated by adding the scores and converting the score to a 100 point scale.

Time frame: 12 months

Change in Pain Visual Analog Scale (VAS) at 12 Months From Baseline

The Visual Analog Scale (VAS) pain score asks the subject to place a vertical mark on a horizontal line (that is approximately 10 cm long) with 'No Pain' (score of 0 = 0 cm) listed on the left and 'Very severe pain' (score of 10=10cm) labeled on the right. The subject is instructed to indicate the amount of pain they feel in their back.

Data from ClinicalTrials.gov

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