Beaumont physicians hopeful investigational drug will regenerate damaged spinal disc tissue

1/23/2007
 

Back in July, Rob Rosso, 32 of Eastpointe, became one of the first persons in the world to have his damaged spinal disc injected with an investigational drug called OP-1&reg. Beaumont Hospital physicians, part of a nationwide research study, are hopeful this drug leads to a new, noninvasive treatment for degenerative disc disease by regenerating spinal disc tissue.

"It's a potentially innovative, nonsurgical treatment for the most common ailment affecting men and women through the ages - lower back pain," says Jeffrey Fischgrund, M.D., orthopedic spine surgeon and the study's research physician at Beaumont.

Beaumont, Royal Oak is only one of two sites nationwide currently participating in the study and the only Michigan site. By February, the study will include five participating sites in the U.S.

Nearly six months since his injection Rosso reflects, "It surpassed my expectations. I was hoping for a reduction in symptoms and now I'm virtually free of back pain. I feel great," says Rosso, a full-time student enrolled in Oakland University's accelerated nursing program.

Before developing his back pain, Rosso, was physically active. He played on his softball team at work. But over time, the pain caused him to not only quit the team, but forgo overtime as a technician in Beaumont's Emergency Center. The nagging pain dramatically changed his lifestyle. He became sedentary and was fearful of doing activities that might aggravate his back.

OP-1® is a protein found naturally in the body. It's important in the development of bone, tissues and organs. The investigational drug, manufactured by Stryker Biotech, is an injectable formulation of the natural OP-1® protein produced through genetic engineering. The injection of OP-1® stimulates cell growth. OP-1® has proven very successful in animal research. The OP-1® degenerative disc disease study will examine the drug's safety and clinical activity across four dose levels in a carefully selected population of patients.

"Over twenty years of research has gone into the study of OP-1®," says Dr. Fischgrund. "Currently, two formulations of OP-1® are approved by the Food and Drug Administration to accelerate the healing process for spinal fusion and long bone fractures in selected patients."

Prior to the injection of OP-1®, patients receive an anesthetic to numb the skin. The investigational drug is injected into the center of the damaged disc by an anesthesiologist under continuous X-ray, known as fluoroscopy. Each patient receives one injection. Through periodic MRIs and X-rays, researchers are able to evaluate the effect of the OP-1® protein on participant's discs.

Usual treatments for degenerative disc disease include physical therapy, pain management and surgical options such as fusion and the removal of the bad spinal discs. "This investigational therapy offers the hope of regenerating damaged discs without surgery," adds Dr. Fischgrund.

Dr. Fischgrund and his medical team are still recruiting patients for the two-year study. There are inclusion criteria for people who would like to be considered for this study. More information is available by calling Beaumont's Orthopedic Surgery research department at 248-551-3533.