ISTO Technologies has completed enrollment of its Phase II clinical trial of NuQu, a novel, cell-based therapy for the treatment of pain and disability associated with degenerated spinal discs.
The company has completed enrollment of 44 patients from nine active research sites across the US for the Phase II randomized, double-blinded trial.
ISTO expects to collect final data for primary outcome measures in the fourth quarter of 2014.
Carolina Neurosurgery and Spine Associates MD Domagoj Coric said that as a cell-based technology, NuQu 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," Coric added.
NuQu is a cell-based therapy based on ISTO's cell-platform technology that harnesses the power of juvenile cartilage cells called chondrocytes.
ISTO Technologies president and chief executive officer Mitchell Seyedin 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."
Currently, NuQu is administered in a single-use for clinical trials patient procedure and is expected to be offered in the same way upon commercialization.