Intradiscal rhGDF-5 Phase I/II Clinical Trial - 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:	NCT00813813

Purpose

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

Condition	Intervention	Phase
Degenerative Disc Disease	Drug: Intradiscal rhGDF-5	Phase 1 Phase 2

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	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

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 and determine an appropriate dose of Intradiscal rhGDF-5 for future investigation [ Time Frame: duration of the study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Investigate the preliminary effectiveness of Intradiscal rhGDF-5 in subjects with early lumbar disc degeneration and test the clinical utility of magnetic resonance imaging (MRI) to evaluate changes in the disc after administration of Intradiscal rhGDF5 [ Time Frame: duration of study ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	48
Study Start Date:	June 2008
Estimated Study Completion Date:	January 2012
Estimated Primary Completion Date:	January 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Intradiscal rhGDF-5	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.

Arms

Assigned Interventions

Experimental: Intradiscal rhGDF-5

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.

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 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

Exclusion Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00813813

Locations

United States, California
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, Illinois
Rehabilitation Institute of Chicago
Chicago, Illinois, United States, 60611
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, Ohio
Riverhills Healthcare, Inc.
Cincinnati, Ohio, United States, 45242
United States, Texas
TBI Clinical Research, LLC
Plano, Texas, United States, 75093
United States, Virginia
Virginia Commonwealth University Spine Center
Richmond, Virginia, United States, 23235

Sponsors and Collaborators

Advanced Technologies and Regenerative Medicine, LLC (ATRM)

DePuy Spine

Investigators

Principal Investigator:	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	Rehabilitation Institute of Chicago
Principal Investigator:	Jonathan Borden, MD	Riverhills Healthcare, Inc.
Principal Investigator:	Yaoming Gu, MD	Virginia Commonwealth University

More Information

No publications provided

Responsible Party:	Advanced Technologies and Regenerative Medicine, LLC (ATRM)
ClinicalTrials.gov Identifier:	NCT00813813 History of Changes
Other Study ID Numbers:	07-Intradiscal rhGDF-5-01
Study First Received:	December 22, 2008
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 May 23, 2012