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

NCT01158924 | Completed Phase 1 Results

• 1 other identifier: 09-Intradiscal rhGDF-5-02
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Early Lumbar Disc Degeneration

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

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

Secondary Outcomes (3)

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

  12 months

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

  12 months

• Change in Physical Component Summary of Quality of Life Measure Assessed by Short-Form 36 at 12 Months From Baseline.

  12 Months

Study Arms (1)

Intradiscal rhGDF-5

EXPERIMENTAL

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

Interventions

Intradiscal rhGDF-5 DRUG

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.

Intradiscal rhGDF-5

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Persons unable to have an MRI
• Abnormal neurological exam at baseline (e.g., chronic radiculopathy)
• 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)
• Suspected symptomatic facet joints and/or severe facet joint degeneration at the index level(s) or adjacent segments
• Suspected symptomatic sacro-iliac joint

Sponsors & Collaborators

• DePuy Spine: lead
• Janssen-Cilag Pty Ltd: collaborator

Study Sites (3)

Hunter Clinical Research

Broadmeadow, New South Wales, 2292, Australia

Location

St. George Private Hospital

Kogarah, New South Wales, 2217, Australia

Location

BrizBain & Spine, The Wesley Hospital

Auchenflower, Queensland, 4066, Australia

Location

MeSH Terms

Conditions

Intervertebral Disc Degeneration

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Results Point of Contact

• Title: Mark Lotito
• Organization: DePuy Synthes Spine

mlotito@its.jnj.com

508-880-8045

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2010
• First Posted: July 8, 2010
• Study Start: March 1, 2010
• Primary Completion: March 1, 2014
• Study Completion: March 1, 2014
• Last Updated: February 26, 2016
• Results First Posted: January 27, 2016

Record last verified: 2016-01

Locations

AU (3)