Degenerative Disc Disease Clinical Trial
Official title:
A Prospective, Double Blind, Controlled Study Evaluating Safety and Preliminary Efficacy of a Single Injection of Adult Mesenchymal Precursor Cells (MPCs) Combined With Hyaluronan in Subjects With Chronic Discogenic Lumbar Back Pain
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.
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