ISTO Cartilage Regeneration Trial Completes Enrollment

ISTO Technologies, Inc., one of the companies in search of the Holy Grail of orthopedics—cartilage regeneration—has completed enrollment of its Phase 2 NuQu clinical trial. The trial is evaluating the efficacy and safety of NuQu, a cell-based therapy for the treatment of degenerative spinal discs.

“Promising and Transformational”

Domagoj Coric, M.D., of Carolina Neurosurgery and Spine Associates and principal investigator of the trial said, “As a cell-based technology, NuQu is very promising and is potentially transformational for a large patient population, enabling pain relief without an invasive surgical procedure. It is the goal of the therapeutically-diverse investigators involved in the trial to evaluate this potential therapy for patients who do not respond to conservative treatment.”

Alternative to Surgery

According to the company, 12.5 million Americans experience chronic back pain each year. Approximately 70% or 8.5 million of those require surgery to correct disc herniation and/or relatively advanced vertebral deterioration. The remaining 30%, or 4 million people, experience less severe deterioration, and are not yet considered surgical candidates. Of these, 85% respond well to repetitive, continued conservative therapy, while the remainder, approximately 10-15%, do not respond to conservative therapy and are excellent candidates for NuQu.

NuQu is currently delivered in clinical trials in a single-use, minimally invasive, out-patient procedure, and it is anticipated that this will remain unchanged upon commercialization. ISTO Technologies believes that the potential regenerative characteristics of NuQu and its “patient-friendly” method of delivery will be viewed favorably by insurance payors as a viable and cost-effective alternative to surgical procedures for those suffering from chronic back pain.

Many patients with back pain show degeneration of cartilage in their intervertebral disc. Typically, says the company, therapeutic treatment begins with conservative measures, such as bed rest, chiropractic care, physical therapy, spinal injections and/or medications including opioids. All of these methodologies are geared toward facilitating movement and relieving pain, but none restore the biology of the disc, and in many patients, will not prevent advancement of disability and the eventual need for surgical correction.

Roger Härtl, M.D., of Weill Cornell Medical College and a NuQu clinical investigator, said “As a regenerative therapy, NuQu marks the beginning of an exciting era. Because it is aimed at restoring cartilage in the disc, without altering the structure of the vertebral column, NuQu may not only heal degeneration, but may also prevent progression of spinal disease to multiple levels.”

NuQu – Juvenile Cartilage Cells

ISTO’s cell-platform technology harnesses the potency of juvenile cartilage cells, called chondrocytes. Scientific data has demonstrated that when compared to adult cells, cartilage produced by juvenile chondrocytes shows 100-fold higher content of proteoglycan, which is a type of protein critical for the development of cartilage connective tissue. This results in greater cartilage matrix production, and maximizes the opportunity to heal cartilage injuries in a variety of clinical settings.

Mitchell Seyedin, Ph.D., president and CEO of ISTO, said, “NuQu utilizes juvenile cartilage cells that are not only remarkably prolific, but are programmed to produce cartilage in the spinal disc, an environment with no vascular supply. This is not possible with other cell types.”

The company’s October 7, 2013 announcement directs readers to clinicaltrials.gov for updates. But, of course, with new clinical trials and new device submissions held hostage by the government shutdown, the site is not current.