Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
32 participants
INTERVENTIONAL
2008-06-30
2013-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
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.
Interventions
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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 Criteria
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Inclusion Criteria
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
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
18 Years
ALL
No
Sponsors
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DePuy Spine
INDUSTRY
Responsible Party
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Principal Investigators
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James Rathmell, MD
Role: PRINCIPAL_INVESTIGATOR
Massachusetts General Hospital
Richard Guyer, MD
Role: PRINCIPAL_INVESTIGATOR
Texas Back Institute
Marvin Tark, MD
Role: PRINCIPAL_INVESTIGATOR
Drug Study America
Jim Youssef, MD
Role: PRINCIPAL_INVESTIGATOR
Durango Orthopedic Associates/Spine Colorado
Norman Harden, MD
Role: PRINCIPAL_INVESTIGATOR
Shirley Ryan AbilityLab
Jonathan Borden, MD
Role: PRINCIPAL_INVESTIGATOR
Riverhills Healthcare, Inc.
Yaoming Gu, MD
Role: PRINCIPAL_INVESTIGATOR
Virginia Commonwealth University
Locations
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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
Massachusetts General Hospital
Boston, Massachusetts, United States
Riverhills Healthcare, Inc.
Cincinnati, Ohio, United States
TBI Clinical Research, LLC
Plano, Texas, United States
Virginia Commonwealth University Spine Center
Richmond, Virginia, United States
Countries
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Other Identifiers
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07-Intradiscal rhGDF-5-01
Identifier Type: -
Identifier Source: org_study_id
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