The purpose of this study is to compare two doses of immunoselected, culture-expanded, nucleated, allogeneic adult MPCs when combined with hyaluronic acid to two control intradiscal injections in subjects with chronic low back pain due to moderate Degenerative Disc Disease (DDD) at one lumbar level from L1 to S1. All investigational subjects in this study will undergo injection of either 6 million (M) or 18M cells in a hyaluronic acid carrier into the degenerated lumbar disc's nucleus pulposus. All control subjects will undergo an intradiscal control injection with either saline or hyaluronic acid only
This is a prospective, multicenter, double blinded, controlled clinical study comparing two doses of immunoselected, culture-expanded, nucleated, allogeneic adult MPCs when combined with hyaluronic acid to two control intradiscal injections in subjects with chronic low back pain (\> 6 months) due to moderate DDD at one lumbar level from L1 to S1 and unresponsive to conservative therapy for at least 3 months (including physical therapy). After the screening and injection visits, each subject will be evaluated clinically and radiographically at 30 days, and again at 3, 6, 12, 24 and 36 months after injection. Subjects will be evaluated at the same time points for safety.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
100
Injection of Low Dose MPCs with Hyaluronic Acid into the degenerated lumbar disc's nucleus pulposus.
Intradiscal control injection with saline solution
Intradiscal control injection with hyaluronic acid
Injection of HighDose MPCs with Hyaluronic Acid into the degenerated lumbar disc's nucleus pulposus.
Arizona Pain Specialists
Scottsdale, Arizona, United States
UC Davis Spine Center
Sacramento, California, United States
The Spine Institute
Santa Monica, California, United States
IPM Medical Group, Inc.
Walnut Creek, California, United States
Denver Spine
Denver, Colorado, United States
Rocky Mountain Associates in Orthopedic Medicine, P.C.
Loveland, Colorado, United States
Emory University School of Medicine
Atlanta, Georgia, United States
Carolina Neurosurgery and Spine Associates
Charlotte, North Carolina, United States
Central Texas Spine Institute
Austin, Texas, United States
Richmond Bone and Joint Clinic, Memorial Hermann Medical Group
Richmond, Texas, United States
...and 4 more locations
To determine the overall safety of MPCs plus carrier using physical examinations, vital signs, treatment emergent adverse events (TEAEs), and the results of clinical lab tests (hematology, serum chemistry, inflammation, and immunology).
Time frame: 3 years
To evaluate the change of treated lumbar intervertebral discs using Magnetic Resonance Imaging (MRI) at 6 months post injection of MPCs.
Time frame: 6 - 36 Months
To evaluate the effectiveness of MPCs in reducing chronic lumbar back pain using the visual analog scale (VAS).
Time frame: 1 - 36 Months
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