Cytori Therapeutics, Inc. (NASDAQ: CYTX) reported preclinical study results, which demonstrate the potential benefit of adipose-derived stem and regenerative cells (ADRCs) for the treatment of damaged intervertebral discs, evidenced by significantly increased disc tissue density and disc-specific extracellular matrix components at 12-months post treatment in a large animal model. The data were presented today at the 2008 Tissue Engineering and Regenerative Medicine International Society meeting.
This study demonstrates the potential of a patient's own ADRCs to repair the spinal disc. While this study relied upon the traditional glassware methodology for ADRC isolation, the Celution System could increase the efficiency and cost-effectiveness of the procedure. The Celution System is an automated, bedside device that isolates autologous ADRCs in a real-time fashion, thus representing a potential novel therapeutic for more than 300,000 patients undergoing spinal surgery annually.
12 months following treatment, discs that received ADRCs in hyaluronic acid (HA) carrier compared to discs treated with HA only demonstrated significantly greater levels of the disc specific extracellular matrix proteins, aggrecan and type II collagen. Viable ADRCs were identified within the discs by histological examination identifying a potential link between the durability of these transplanted cells and improved condition of the discs. "This histologic data shows that ADRCs may contribute to the regeneration of the spinal disc and form a healthier, more natural inner-disc space than HA alone," said Jrg Meisel, M.D., Ph.D., the Director of Neurosurgery at the Bergmannstrost Klinik in Germany."
In addition, in this preclinical study at 12 months post therapy, injured discs that were treated with ADRCs in HA showed significantly greater disc density. This finding is based on independent assessments of T2 weighted MRI, compared to injured discs that received no treatment.
As part of the study design, 12 large animals (6 for each time point), underwent injury of three lumbar discs. Six weeks following the injury, the three discs were randomly assigned to receive autologous ADRCs suspended in HA, HA only (control) or no treatment. The discs were then assessed at 6 and 12 months after treatment for matrix hydration and morphology, which both showed significant improvement in the ADRC treated discs. All ADRC treatments were well tolerated, evidenced by the lack of inflammation within the disc space. The reported results are a subset of top-line findings which will be reported in full in the Spring of 2009.
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