Genetically Engineered Human Protein (rhGDF-5) For Degenerative Disc Disease

**Justin** · 08-23-2009, 08:56 PM

Intradiscal rhGDF-5 Phase I/II Clinical Trial

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.

This study is currently recruiting participants.
Verified by Advanced Technologies and Regenerative Medicine, LLC (ATRM), July 2009
First Received: December 22, 2008 Last Updated: July 28, 2009

Study Type: Interventional
Study Design: Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
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 (Enrollment as of 5/15/09: 16 patients, Click here for up-to-date information.)
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)

Intradiscal rhGDF-5: Experimental
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

Locations

United States, California

Spine Institute Not yet recruiting

Santa Monica, California, United States, 90404
Contact: Nupur Gupta, MPH 310-449-6587 ngupta (at) laspineinstitute.com
Principal Investigator: Hyun Bae, MD
Sub-Investigator: Timothy Davis, MD

United States, Colorado

Durango Orthopedic Associates/Spine Colorado Recruiting

Durango, Colorado, United States, 81301
Contact: Katie Patty 970-375-3696 kpatty (at) spinecolorado.com
Contact: Jim Youssef, MD
Principal Investigator: Jim Youssef, MD
Sub-Investigator: Cyril Bohachevsky, MD

United States, Florida

Florida Institute of Medical Research Recruiting

Jacksonville, Florida, United States, 32257
Contact: Theresa Hanburry 904-448-0239 thanburry (at) theipm.com
Contact: Orlando Florete, MD
Principal Investigator: Orlando Florete, MD
Sub-Investigator: Bernard Canlas, MD

United States, Georgia

Emory University School of Medicine Recruiting

Atlanta, Georgia, United States, 30329
Contact: Shawndra Woodard 404-778-6831 shawndrawoodard (at) emoryhealthcare.org
Contact: Tim Yoon, MD
Principal Investigator: Tim Yoon, MD
Sub-Investigator: Howard Levy, MD
Sub-Investigator: Michael Schaufele, MD

Drug Studies America Recruiting

Marietta, Georgia, United States, 30060
Contact: Patti Housley, RN 678-581-5252 ext 224 phousley (at) drugstudies.net
Contact: Marvin Tark, MD
Principal Investigator: Marvin Tark, MD
Sub-Investigator: Thomas Hurd, MD
Sub-Investigator: Ernest Itkin, MD

United States, Illinois

Rush University Medical Center Recruiting

Chicago, Illinois, United States, 60612
Contact: Margaret Hickey 312-432-2358 margaret.hickey (at) ruthortho.com
Contact: Howard An, MD
Principal Investigator: Howard An, MD
Sub-Investigator: Kern Singh, MD
Sub-Investigator: Edward Goldberg, MD
Sub-Investigator: Frank Phillips, MD
Sub-Investigator: Gunnar Anderssen, MD
Sub-Investigator: April Fetzer, MD

Rehabilitation Institute of Chicago Recruiting

Chicago, Illinois, United States, 60611
Contact: Sarah Thilges 312-238-7624 sthilges (at) ric.org
Contact: Norman Harden, MD
Principal Investigator: Norman Harden, MD
Sub-Investigator: Joshua Rittenberg, MD

United States, Maryland

Suburban Hospital Health Care System Not yet recruiting

Bethesda, Maryland, United States, 20814
Contact: Jodie Stone, PA 301-896-3202 jaugaz (at) aol.com
Principal Investigator: Wayne Olan, MD
Sub-Investigator: E P Passamani, MD

United States, Massachusetts

Massachusetts General Hospital Recruiting

Boston, Massachusetts, United States, 02114
Contact: Naomi Shin 617-726-5186 nshin (at) partners.org
Contact: James Rathmell, MD
Sub-Investigator: Christopher Gilligan, MD
Principal Investigator: James Rathmell, MD
Sub-Investigator: William Palmer, MD

United States, Ohio

Riverhills Healthcare, Inc. Recruiting

Cincinnati, Ohio, United States, 45242
Contact: Jennifer Palmer 513-241-2370 ext 201 jpalmer (at) rhihealth.com
Contact: Jonathan Borden, MD
Principal Investigator: Jonathan Borden, MD
Sub-Investigator: Onassis Caneris, MD

United States, Texas

Texas Back Institute Recruiting

Plano, Texas, United States, 75093
Contact: Dawn DeLacy 972-403-5544 ddlacey (at) spinemarkcro.com
Contact: richard Guyer, MD
Principal Investigator: Richard Guyer, MD
Principal Investigator: Michael Hisey, MD
Sub-Investigator: Ken Jones, MD
Sub-Investigator: Scott Blumenthal, MD
Sub-Investigator: Raj Arakal, MD

Texas Spine & Joint Hospital Not yet recruiting

Tyler, Texas, United States, 75701
Contact: Marolyn Stocks 903-531-2500 marolyns (at) gordonspine.com
Principal Investigator: Aaron Calodney, MD
Sub-Investigator: Duane Lee Griffith, MD

United States, Virginia

Virginia Commonwealth University Spine Center Not yet recruiting

Richmond, Virginia, United States, 23235
Contact: Tammy Anderson, CCRC, CCRA 804-827-1856 tnanders (at) vcu.edu
Principal Investigator: Michael DePalma, MD

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: Orlando Florete, MD Florida Institute of Medical Research
Principal Investigator: Tim Yoon, MD Emory University
Principal Investigator: Howard An, MD Rush University Medical Center
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: Aaron Calodney, MD Texas Spine & Joint Hospital
Principal Investigator: Hyun Bae, MD Spine Institute

Responsible Party: Regenerative Therapeutics ( Emmanual Lazaro, Director, Clinical Affairs )
Study ID Numbers: 07-Intradiscal rhGDF-5-01
Study First Received: December 22, 2008
Last Updated: July 28, 2009
ClinicalTrials.gov Identifier: NCT00813813
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:

Spinal Diseases
Signs and Symptoms
Musculoskeletal Diseases
Mitogens
Bone Diseases

Additional relevant MeSH terms:

Spinal Diseases
Musculoskeletal Diseases
Bone Diseases

ClinicalTrials.gov, August 21, 2009 (Click here for the rhGDF-5 Clinical Trial.)

For up-to-date information regarding this study, please visit the Clinical Trials Wiki website.

**daveinaustin** · 08-24-2009, 08:12 AM

This seems like a very exciting trial for those who have moderate DDD without a leaking disc. I look forward to learning more about its efficacy.

**Justin** · 12-02-2009, 12:34 PM

Injection could help regrow spine, reduce back pain. (Click here for VIDEO)

by JEAN ENERSEN / KING 5 News
Posted on December 1, 2009 at 4

6 PM
Updated yesterday at 6

8 PM

Rebecca Tirs spends most days in bed with her dog, Jenny-Bee.

Ten years ago, Rebecca was an active 28-year-old. Then came a roll-over car accident.

"I had a mild traumatic brain injury. I had a fractured pelvis. I had fractured scapula, fractured ribs," she said.

Rebecca also tore two discs. She can barely walk now and had to quit work
"I cried all the time," she said.

Dr. Michael DePalma of Virginia Commonwealth University Spine Center is working on a new way to heal injured backs. As part of a clinical trial, he injects natural growth factors into damaged discs.

"The growth factors are that, they stimulate growth of certain tissue," he said.

The injection includes a growth factor called OP-1, a key ingredient in the development of bone and tissue. In animals, the shot helped damaged discs grow back now it's being tested in humans.

"This sort of treatment may find its role in treating the disc before they get to a point beyond which only surgery is going to help," said Dr. DePalma.
Rebecca doesn't know if she received a placebo or the real thing, but her pain level has improved.

"Instead of maybe an eight or a nine, I was a seven," she said.
She says every bit helps if it gets her one step closer to her old, vibrant self.

Several medical sites across the country are participating in the trial: Intradiscal rhGDF-5 Phase I/II Clinical Trial