ISTO Technologies, Inc. Announces FDA Approval to Initiate a Clinical Trial for a Novel Treatment for Disc Nucleus Regeneration
ISTO Technologies, Inc. announced today that it has received notification from the U.S. Food and Drug Administration (FDA) allowing the company to proceed with a Phase I clinical study for NuQu(TM), a cell-based injectable formulation of juvenile chondrocytes designed to regenerate cartilage, restore disc function and relieve discogenic back pain. Research studies have shown that juvenile cartilage cells regenerate cartilage in both in vitro and in vivo environments. NuQu is intended as an early intervention treatment for patients suffering from low back pain by potentially repairing cell biology in a damaged disc, restoring health and improving function.
“The disc environment is only conducive to specialized cells. Our research demonstrates that juvenile chondrocytes may be a good substitute for the nucleus cells that are lost to chronic degeneration,” said Jeffery Lotz, Ph.D., Director of the Orthopaedic Bioengineering Laboratory at University of California, San Francisco, a research collaborator on the NuQu program.
