A Multicenter, Randomized, Double-blind, Placebo Controlled, Clinical Trial to Evaluate the Safety, Tolerability and Preliminary Effectiveness of 2 Doses of Intradiscal rhGDF-5 (Single Administration) for the Treatment of Early Stage Lumbar Disc Degeneration - Full Text View

Sponsor:	Advanced Technologies and Regenerative Medicine, LLC (ATRM)
Collaborator:	DePuy Spine
Information provided by (Responsible Party):	Advanced Technologies and Regenerative Medicine, LLC (ATRM)
ClinicalTrials.gov Identifier:	NCT01124006

Purpose

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

Condition	Intervention	Phase
Degenerative Disc Disease	Drug: Intradiscal rhGDF-5 Other: Water for injection	Phase II

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment

Further study details as provided by Advanced Technologies and Regenerative Medicine, LLC (ATRM):

Primary Outcome Measures:

Evaluate the safety and tolerability of Intradiscal rhGDF-5 in subjects with early lumbar disc degeneration [ Time Frame: Through a 12-month period and annual telephone contact at 24 and 36 months for subject health status follow-up ] [ Designated as safety issue: Yes ]
Clinical outcome measurements and safety outcomes (adverse events, neurological status, and standard lab results of CBC, blood chemistry and rhGDF-5 antibody analysis)

Secondary Outcome Measures:

Investigate the preliminary effectiveness of Intradiscal rhGDF-5 as compared to placebo in subjects with early lumbar disc degeneration [ Time Frame: Through a 12-month period and annual telephone contact at 24 and 36 months for subject health status follow-up ] [ Designated as safety issue: Yes ]
Clinical outcome measurements and safety outcomes (adverse events, neurological status, and standard lab results of CBC, blood chemistry and rhGDF-5 antibody analysis)

Estimated Enrollment:	30
Study Start Date:	January 2010
Estimated Study Completion Date:	April 2013
Estimated Primary Completion Date:	April 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Intradiscal rhGDF-5 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 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.
Placebo Comparator: Water for injection Sterile water for injection	Other: Water for injection Sterile water for injection

Arms

Assigned Interventions

Experimental: Intradiscal rhGDF-5

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

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.

Placebo Comparator: Water for injection

Sterile water for injection

Other: Water for injection

Sterile water for injection

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Persistent low back pain with at least 3 months of non-surgical therapy at one suspected symptomatic lumbar level (L3/L4 to L5/S1) as confirmed using a standardized provocative discography protocol. The required discography protocol will be provided by the sponsor. Subjects with multilevel disease must have a provocative discogram confirming that only 1 level is symptomatic at least 2 weeks prior to administration. Historical provocative discograms may be used for screening purposes, with an expiry of 12 calendar months from the date performed. If the study treatment is not performed within those 12 calendar months, a new discogram will be required.
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

Exclusion Criteria:

Persons unable to have a discogram, CT, or MRI
Abnormal neurological exam at baseline (e.g., chronic radiculopathy)
Active radicular pain due to anatomical compression such as stenosis or disc herniation (radicular pain is defined as pain below the knee)
Extravasation of contrast agent during the discogram, into the epidural space (does not include leakage of contrast agent along the needle track or leakage to the outer annular ring at the posterior longitudinal ligament vicinity)
Suspected symptomatic facet joints and/or severe facet joint degeneration at the index level or adjacent segments

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01124006

Locations

United States, Arizona
Hope Research Institute
Phoenix, Arizona, United States, 85050
United States, California
The Spine Institute
Santa Monica, California, United States, 90404
United States, Colorado
Durango Orthopedic Associates/Spine Colorado
Durango, Colorado, United States, 81301
United States, Georgia
Drug Studies America
Marietta, Georgia, United States, 30060
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
United States, New York
Hospital for Special Surgery
New York, New York, United States, 10021
United States, Pennsylvania
University Orthopedics Center
State College, Pennsylvania, United States, 16801
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29401
United States, Texas
Spine Team Texas
Southlake, Texas, United States, 76092
Texas Spine & Joint Hospital
Tyler, Texas, United States, 75701

Sponsors and Collaborators

Advanced Technologies and Regenerative Medicine, LLC (ATRM)

DePuy Spine

More Information

No publications provided

Responsible Party:	Advanced Technologies and Regenerative Medicine, LLC (ATRM)
ClinicalTrials.gov Identifier:	NCT01124006 History of Changes
Other Study ID Numbers:	09-Intradiscal rhGDF-5-04
Study First Received:	May 11, 2010
Last Updated:	December 21, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Intervertebral Disk Degeneration
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on February 09, 2012