Colorado Doc Injects Stem Cells

Originally published in Orthopedics This Week by Biloine W. Young | Fri, Aug 26, 2011

Author with Dr. Kenneth Pettine/Source: RRY Publications LLC

Colorado spine surgeon Kenneth Pettine of the Spine Institute and Loveland Surgery Center, has just performed the first minimally-invasive lumbar disc procedure in the Phase 2 clinical trial of mesenchymal precursor cells (MPC) for the treatment of low back pain and degenerative disc disease. The developer of MPC is Mesoblast Limited, a regenerative medicine company based in Melbourne, Australia. Dr, Pettine is the co-inventor of Medtronic’s Maverick artificial lumbar disc device.

The outpatient procedure lasted less than 20 minutes. The patient was fully awake, under light sedation and was discharged by Pettine shortly after. There were no complications.

Commenting on the stem cell treatment, Pettine said, "This marks the third renaissance in spine care. The first was improved diagnosis using Magnetic Resonance Imaging (MRI), the second was end-stage replacement with artificial discs, and now there is the potential widespread use of adult stem cells for disc repair and regeneration."

This marks the third renaissance in spine care. The first was improved diagnosis using Magnetic Resonance Imaging (MRI), the second was end-stage replacementIn preclinical trials, the company claims that a single minimally invasive injection of Mesoblast's allogeneic MPCs into severely damaged intervertebral discs resulted in significant reversal of the degenerative process, regrowth of disc cartilage, and sustained normalization of disc pathology, anatomy and function for at least six months.

Building on these results, Mesoblast hopes to show through Phase 2 of its clinical trial that a single minimally invasive injection of its allogeneic or off-the-shelf disc repair MPC product can regenerate damaged discs, reduce pain, improve function, and avoid surgery for patients experiencing lower back pain. Mesoblast's Phase 2 trial, which the United States Food and Drug Administration (FDA) cleared in July, will enroll 100 patients with chronic low back pain due to lumbar disc degeneration in 15 centers across the United States and Australia. Researchers will compare outcomes at six months in 60 patients receiving MPC injections against 40 patients receiving control injections with artificial discs, and now there is the potential widespread use of adult stem cells for disc repair and regeneration.

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Northern Colorado Spine Surgeon Successfully Performs First Minimally Invasive Lumbar Disc Procedure Using Adult Stem Cells

First Procedure in Phase 2 Clinical Trial of Mesoblast’s Adult Mesenchymal Precursor Cell (MPC) Product

Dr. Kenneth Pettine of The Spine Institute in Loveland, CO successfully performed the first minimally invasive lumbar disc procedure in the Phase 2 clinical trial of Mesoblast’s investigational adult Mesenchymal Precursor Cell (MPC) product for low back pain and degenerative disc disease. The outpatient procedure lasted less than 20 minutes, with the patient fully awake and under light sedation. The patient was shortly discharged and there were no complications.

The procedure took place at The Spine Institute and Loveland Surgery Center in Colorado, a United States Spine Center of Excellence. Dr. Pettine is a founder of The Spine Institute, an international leader in non-fusion surgery of the spine, and the co-inventor of Medtronic’s Maverick artificial lumbar disc device.

“This marks the third renaissance in spine care,” Dr. Pettine said. “The first was improved diagnosis using Magnetic Resonance Imaging (MRI), the second was end-stage replacement with artificial discs, and now there is the potential widespread use of adult stem cells for disc repair and regeneration.”

Up to 15 percent of people in industrialized countries have chronic low back pain lasting more than six months.  For those with progressive, severe and debilitating pain due to ongoing progression of disc degeneration, the only option is major back surgery involving artificial disc replacement or spinal fusion.  Both types of surgery are associated with significant risks, and the avoidance of surgery is a major objective of new treatments for degenerative disease of the spine.

Building on these results, Mesoblast aims to show that a single minimally invasive injection of its allogeneic, or off-the-shelf, disc repair MPC product can regenerate damaged discs, thereby reducing pain, improving function, and avoiding surgery.  Mesoblast’s Phase 2 trial, which was cleared by the United States Food and Drug Administration (FDA) in July, will enroll 100 patients with chronic low back pain due to lumbar disc degeneration in 15 centers across the United States and Australia, comparing outcomes at six months in 60 patients receiving MPC injections against 40 patients receiving control injections.

“There is a significant need for a minimally invasive biological solution to repair the degenerating disc, reduce back pain, improve function, and eliminate the need for surgery. Mesoblast’s adult stem cell product could find broad use in the treatment of both early and late degenerative disc disease, and could additionally reduce spine surgery for this condition by as much as 80 percent,” Dr. Pettine added.

Those interested in becoming a candidate for the Phase 2 clinical trial are encouraged to contact The Spine Institute at 800-795-5487 or 970-669-8881.


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Orthopedic & Spine Industry Leader to Know: Dr. Ken Pettine

Originally published in Becker's Orthopedic, Spine & Pain Management Review by  Rachel Fields | June 16, 2010


Dr. Ken Pettine, co-founder of Colorado's Rocky Mountain Associates in Orthopedic Medicine and The Spine Institute, has one piece of advice for his patients: "Friends don't let friends get fused." This phrase, which he trademarked as the tagline for The Spine Institute, communicates his belief that disc and facet replacement devices provide better treatment for spinal injuries and degeneration than traditional spinal fusion.

Dr. Pettine is the chief investigator for 13 different FDA studies on nonfusion technology, as well as an active researcher. He has an extensive background in spinal surgery, research and rehabilitation and is a member of the American Academy of Orthopedic Surgeons, the North American Spine Society and the Spine Arthroplasty Society. In February he was named to Becker's ASC Review's list of "50 of the Best Spine Specialists in America".

Dr. Pettine completed his residency and master's degree in orthopedic surgery at Mayo Clinic and received his medical degree from the University of Colorado School of Medicine. After completing his spine fellowship training at the Institute for Low Back Care in Minneapolis, he partnered with E. Jeffrey Donner, MD, to found RMA Ortho in 1991 and The Spine Institute in 2004. Along with W. Carlton Reckling, MD, Drs. Donner and Pettine have completed hundreds of spine procedures, making them three of the most experienced spine surgeons in the country. They are also some of the only surgeons nationwide qualified to implant artificial discs and spine stabilization devices.

Dr. Pettine is the co-designer and co-inventor of the MaverickTM Artificial Disc, a patented disc replacement device for the neck and back. The disc is currently the subject of a clinical trial, but while they wait, Dr. Pettine and his co-workers are venturing into other research territory. The Spine Institute plans to explore the possibility of adult stem cell therapy for bone fractures and spine disease, as well as the regeneration of damaged cartilage and invertebral discs.

"It's about staying ahead of the curve and always looking for new and better ways to help patients," Dr. Pettine told Style Magazine. "This was the vision from the beginning. It's so exciting, I've lost sleep thinking about it."


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