Definitive Back-Pain Study?

written by Biloine W. Young | Orthopedics This Week | Dec. 6, 2011


Can a single injection of stem cells repair and regenerate diseased lumbar discs? That question may soon be answered by the first of its kind nationwide study that will test the safety and efficacy of the use of mesenchymal precursor cells (MPCs) to replace bone, cartilage and muscle.

Headquartered at the University of California, Davis, the study will be directed by Dr. Kee Kim, associate professor and chief of spinal neurosurgery at UC Davis Health System. He will collaborate with Scott Fishman, professor and chief of pain medicine and co-principal investigator, to monitor the patients' progress.

An estimated 30 million people in the United States suffer from back pain. Degenerative disc disease is the most common cause of low-back pain, which develops with the gradual loss of a material called proteoglycan, which cushions the bones of the spine and enables normal motion.

"Many scientists and clinicians have injected all different kinds of material into the degenerated disc, hoping that something good will happen. Thus far, we have not been very successful, but we hope that a stem cell-based therapy will be the answer that we have been seeking for decades," Kim said. In pre-clinical studies on sheep with discs that were damaged or degenerated, a single injection of the stem cells was found to make the discs indistinguishable from healthy ones.

"If safety and efficacy are shown in the study, this would be revolutionary,” Kim noted. “It would imply that we can possibly turn back the clock on aging by not only stopping the progression of degenerative changes in the disc, but also reversing the degenerative process," he said. The researchers plan one single injection of adult stem cells directly into the diseased lumbar discs.

Researchers will enroll approximately 100 study participants, 10 at UC Davis and the rest at 11 other medical centers throughout the country. The participants will be individuals who have suffered from moderate low-back pain for a minimum of six months and whose condition has not responded to other, conventional treatments.

The patients will be divided into four groups. One group will receive a high dose of MPCs plus hyaluronic acid, a substance that facilitates the localization and retention of the stem cells. A second group will receive a lower dose of MPCs, plus the hyaluronic acid. A third group will receive the hyaluronic acid alone and a fourth group will receive only the saline solution.

"As an investigator, the design of this study is one of its most attractive features. This type of randomized study where the patients are blinded to the treatment is as good as it's going to get to eliminate any possible bias," Kim said.

The current study is sponsored by Mesoblast Ltd., of Melbourne, Australia, which is investigating stem cell technology to regenerate and repair bone and cartilage. The MPCs are derived from a single adult donor's bone marrow to ensure homogeneity, thus minimizing the risk of rejection by the recipient. Kim will not receive compensation from Mesoblast for his participation in the study.

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