Saint John’s Health Center is currently seeking candidates to participate in clinical studies for lumbar (low back) and cervical (neck) fusion procedures. Using allogeneic, or “off the shelf†, adult stem cell technology, Saint John’s Health Center is one of just eight sites in the United States to participate in two new Phase II clinical studies that have been cleared by the U.S. Food and Drug Administration and sponsored by Mesoblast Ltd. (New York City, NY). These studies are intended to demonstrate the safety of allogeneic stem cells in spinal fusion procedures as well as to provide information about the potential benefits of stem-cell therapy.
Back and neck pain affect more than 80 percent of Americans some time in their lives and accounts for more sick leave and disability than any other medical condition. More than 500,000 spinal fusion procedures for chronic low back and neck pain are performed annually in the United States alone, with the standard therapy being hip bone autograft obtained from a second surgical procedure. Mesoblast’s NeoFuseâ„¢ aims to eliminate the need for a second procedure to harvest the patient’s own bone, with its associated risk of infection and chronic hip pain.
The lumbar fusion study is investigating whether a product containing proprietary adult stem cells, called NeoFuseâ„¢, can provide equivalent or better fusion outcomes compared to a bone graft following conventional lumbar fusion procedures. Patients in the NeoFuseâ„¢ study group will receive an implantation of either 25 million or 75 million NeoFuseâ„¢ adult stem cells mixed with a carrier graft material between the bones that require fusion. The control group will receive a bone graft from the patient’s own hip (autograft).
The cervical fusion study will compare the results of using NeoFuseâ„¢ adult stem cells against cadaver bone graft in two or three level cervical (neck) fusion procedures. These procedures have a significantly lower success rate compared to single level fusions.
NeoFuseâ„¢ stem cells used in these clinical studies are a type of stem cell called mesenchymal precursor cells or MPCs that are derived from the bone marrow of healthy young adults. They are screened for communicable diseases, purified and grown into very large quantities in a sterile controlled laboratory environment.
Mesoblast is currently evaluating the effectiveness and safety of NeoFuseâ„¢ for minimally invasive spinal fusion surgery of the cervical and lumbar spine in about 50 patients randomized to receive either NeoFuseâ„¢ or standard therapy across two Phase 2 trials cleared by the United States Food and Drug Administration (FDA).
“We are very excited about being selected as a site to participate in this new study,†said Hyun Bae, M.D., orthopedic spine surgeon at Saint John’s Health Center and principal investigator for the Mesoblast study. “Our primary goal is to identify the appropriate patient candidates so that we can accurately measure the efficacy of NeoFuseâ„¢ and its potential to enhance outcomes for patients undergoing lumbar or cervical fusions.â€
If you or someone you know is interested in participating in the NeoFuseâ„¢ lumbar or cervical fusion clinical trials, please contact Janice Kim at (310) 248-7348 or Baevip@gmail.com. To learn more about these clinical studies, please visit www.clinicaltrials.gov.
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About Saint John’s Health Center
Since its founding in 1942 by the Sisters of Charity of Leavenworth, Saint John’s Health Center has been providing the patients and families of Santa Monica, West Los Angeles and ocean communities with breakthrough medicine and inspired healing. Saint John’s provides a spectrum of treatment and diagnostic services with distinguished areas of excellence in cancer care, spine, orthopedics, women’s health, cardiac care and specialized programs such as the internationally acclaimed John Wayne Cancer Institute. Saint John’s is dedicated to bringing to the community the most innovative advances in medicine and technology. For more information, visit www.newsaintjohns.org.
About Mesoblast
Mesoblast Limited (ASX:MSB; ADR:MBLTY) is headquartered in Melbourne, Australia with a U.S. subsidiary located in New York City. The world leader in commercializing biologic products for the broad field of regenerative medicine, Mesoblast is actively conducting U.S. clinical studies for a wide range of therapeutic applications, including degenerative disk disease, congestive heart failure and heart attacks, and expansion of cord blood for bone marrow transplants with clinical studies in eye diseases and diabetes to commence soon. Mesoblast has the worldwide exclusive rights for a series of patents and technologies developed during the past 15 years relating to the identification, extraction, culture and uses of adult Mesenchymal Precursor Cells (MPCs). For more information, please visit www.mesoblast.com.
