ISTO Technologies, Inc. is initiating a Phase II trial to further the efficacy and safety of its NuQu cell-based therapy for the treatment of pain and disability associated with degenerated spinal discs. Enrollment in the randomized, double-blinded, placebo-controlled trial is expected to be commenced by the end of 2012 and interim results reported by the end of 2013.
ISTO’s NuQu in Phase II Trial
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Domagoj Coric, M.D., lead clinical investigator for the project and a practicing neurosurgeon at Carolina Neurosurgery and Spine Associates in Charlotte, North Carolina, said data from 15 patients treated in the Phase I trial “shows considerable promise in safety, with the potential of offering patients relief with little or no recovery time. NuQu could become a preferred alternative for those patients with chronic low back pain, who do not respond to traditional, nonsurgical care such as physical therapy or epidural steroid injections. Currently, the only options for these patients are to either live in pain or to undergo a major surgical procedure.”
St. Louis, Missouri-based ISTO has developed a platform technology for cartilage regeneration based on research from Washington University. Damaged cartilage does not normally heal and leads to conditions such as osteoarthritis and back pain. The company’s technology is based on the expansion of juvenile cartilage cells, which, according to the company, possess a significant higher capacity to regenerate and restore healthy tissue when compared to adult cells.
“We are hopeful that early treatment of lower back pain with this regenerative product could be potentially transformational for a very large patient population, enabling pain relief without the need for an invasive surgical procedure, ” stated Dr. Mitchell Seyedin, President & CEO of ISTO. “We are thrilled with our progress in the development of this exciting product through clinical trials.”
NuQu is an injectable cell-based therapy derived from the company’s cartilage regeneration platform technology.
ISTO was presented with a 2012 Orthopedics This Week Spine Technology Award for the NuQu technology.
In addition to NuQu, the company’s other product derived from the cartilage regeneration platform is DeNovo ET, a scaffold-free engineered cartilage tissue, intended for the repair of damaged articular cartilage in the knee. DeNovo ET is developed in partnership with Zimmer Holdings, Inc., In addition to the cell-based cartilage programs; the company is producing and marketing InQu, a bone graft extender and substitute. InQu combines integrated hyaluronic acid and a resorbable polymer for better handling and biology. The primary target market for InQu is spinal fusion applications.
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This is a fascinating development. In my practice we've seen similar outcomes with the revised protocol. The key differentiator seems to be patient selection criteria. Has anyone else noticed the correlation with BMI thresholds?
Great point. I'd push back slightly on the conclusion, the sample size in the cited study is too small to draw population-level inferences. That said, the directional signal is compelling and worth a larger RCT.
We implemented a similar approach last year. Early results are promising but we're still gathering 12-month follow-up data. Happy to share our protocol if anyone is interested.
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