Intradiscal rhGDF-5 Phase I/II Clinical Trial

NCT00813813 | Completed Phase 1 Results DMC

• 1 other identifier: 07-Intradiscal rhGDF-5-01
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 8

Brief 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

Conditions

Degenerative Disc Disease

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 (4)

• 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

• Change in Mental Component Summary Quality of Life Measure Assessed by Short Form SF-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 symptomatic lumbar level (L3/L4 to L5/S1) as confirmed using a standardized discography protocol
• Oswestry Disability Index of 30 or greater
• 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

You may not qualify if:

• Persons unable to have a discogram, CT or an MRI
• Abnormal neurological exam at baseline (e.g., radiculopathy)
• Radicular pain
• Leak of contrast agent during the discogram, into the epidural space (does not include leak of contrast agent along the needle track)
• 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

Sponsors & Collaborators

• DePuy Spine: lead

Study Sites (8)

Spine Institute

Santa Monica, California, 90404, United States

Location

Durango Orthopedic Associates/Spine Colorado

Durango, Colorado, 81301, United States

Location

Drug Studies America

Marietta, Georgia, 30060, United States

Location

Rehabilitation Institute of Chicago

Chicago, Illinois, 60611, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Riverhills Healthcare, Inc.

Cincinnati, Ohio, 45242, United States

Location

TBI Clinical Research, LLC

Plano, Texas, 75093, United States

Location

Virginia Commonwealth University Spine Center

Richmond, Virginia, 23235, United States

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

Study Officials

• James Rathmell, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

• Richard Guyer, MD

  Texas Back Institute

  PRINCIPAL INVESTIGATOR

• Marvin Tark, MD

  Drug Study America

  PRINCIPAL INVESTIGATOR

• Jim Youssef, MD

  Durango Orthopedic Associates/Spine Colorado

  PRINCIPAL INVESTIGATOR

• Norman Harden, MD

  Shirley Ryan AbilityLab

  PRINCIPAL INVESTIGATOR

• Jonathan Borden, MD

  Riverhills Healthcare, Inc.

  PRINCIPAL INVESTIGATOR

• Yaoming Gu, MD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

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
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2008
• First Posted: December 23, 2008
• Study Start: June 1, 2008
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: February 26, 2016
• Results First Posted: January 27, 2016

Record last verified: 2016-01

Locations

US (8)