RAYNHAM, MA – April 1, 2009 – DePuy Spine, Inc., in collaboration with Advanced Technologies and Regenerative Medicine, LLC, announced today it has begun testing of a genetically engineered human protein in patients with moderate to severe low back pain. The first in a series of clinical studies evaluating the safety and effectiveness of the protein, intradiscal rhGDF-5 (recombinant human growth and differentiation factor-5), began
at Texas Back Institute in Plano, Texas.
The study outcomes will evaluate if injections of rhGDF-5 into the lower spine can relieve pain and slow or even reverse early stage degenerative disc disease. Researchers at 10 centers in the U.S. are part of this placebo-controlled, double-blind, randomized Phase I-II study that will follow patients for up to three years. This product is investigational only within the United States. The rhGDF-5 protein is being used under license from Biopharm GmbH.
“In animal studies, the injection of rhGDF-5 influenced the growth and differentiation of numerous tissues including the intervertebral disc but these studies are limited in their ability to assess discogenic pain,” said Richard Guyer, MD, a clinical investigator and spine surgeon at Texas Back Institute. “For the first time, in a carefully controlled study, we will see how this recombinant version of human growth and differentiation factor-5 works with actual patients.”
The study consists of patients who have had persistent discogenic back pain for at least three months at one symptomatic lumbar level from L3/L4 to L5/S1 and who have not responded to conservative medical treatment such as physical therapy. Clinical outcomes will be measured using standard validated tools and lumbar disc changes will be measured using magnetic resonance imaging (MRI) data.