FDA approves new treatment for disc nucleus regeneration for Phase I clinical trial


Injectable formulation of juvenile chondrocytes, designed to regenerate cartilage and restore disc function given the green signal.

ISTO Technologies has announced that it has received notification from the FDA, which allows the company to proceed with a Phase I clinical study for NuQu, a cell-based injectable formulation of juvenile chondrocytes designed to regenerate cartilage, restore disc function and relieve discogenic back pain.

Research has 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 specialised 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, Director of the Orthopaedic Bioengineering Laboratory at University of California, San Francisco, a research collaborator on the NuQu program.

“Disc nucleus regeneration and repair represent an important area of ongoing spine research because it offers the promise of a minimally invasive intervention that treats a patient’s symptoms while potentially restoring function to the disc,” said Dom Coric, Chief, Department of Neurosurgery, Carolinas Medical Center.

Discogenic back pain impacts about four million patients annually in the United States with approximately 500,000 individuals not responding to conservative treatments, such as bed rest, non-steroidal anti-inflammatory pain medication and physical therapy. It is anticipated that treatment with NuQu may offer pain relief to those suffering from chronic back pain by repairing and regenerating cartilage in the spine. In addition to the physical pain endured by those afflicted by chronic back pain, there are significant economic and social costs to the healthcare system in America and the overall economy.

Conservative estimates place the economic cost of back pain in the United States to be $100 billion annually, with approximately $26 billion of that amount directly attributable to treating the back pain.

Mitchell Seyedin, President and CEO of ISTO, said, “Moving the NuQu program into clinical evaluation represents an important achievement for ISTO and a notable milestone for those individuals suffering from chronic back pain. We believe that our cell-based therapy utilizing juvenile chondrocytes represents the future of spine care.”