ISTO Technologies, Inc.’s NuQu cell-based biological therapy to treat lower back pain had no serious and unexpected safety concerns, showed promising treatment results and could eliminate a number of surgical spine procedures.
NuQu’s Promising Phase I Results
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Secondary
That’s the conclusion of a scientific paper reporting on Phase I of a clinical trial of the therapy published in the latest Journal of Neurosurgery.
The manuscript, entitled, “Prospective study of disc repair with allogeneic chondrocytes, ” was submitted by Domagoj Coric, M.D., Kenneth Petting, M.D., Andrew Sumac, M.D. and Margaret O. Boltes, R.N.
12 Month Post-Treatment
The authors report 12 month post-treatment results of a single-arm study using MRIs, the Oswestry Disability Index (ODI), the Numerical Rating Scale (NRS), the 36-Item Short Form Health Survey (SF-36) and other measures. The study was designed to evaluate the safety and initial efficacy of NuQu in 15 patients at 2 clinical sites.
Dr. Coric, lead clinical investigator for the project and a practicing neurosurgeon at Carolina Neurosurgery and Spine Associates and chief of neurosurgery at Carolinas Medical Center, both in Charlotte, North Carolina, commented, “Given the limited treatment options available today for patients suffering from chronic low back pain, NuQu potentially represents a unique and innovative technology that could eliminate a number of surgical procedures and improve quality of life for a sizable patient population.”
NuQu
NuQu is comprised of tissue-expanded juvenile chondrocytes that are supplied frozen to the physician, and then thawed and combined with a fibrin carrier at the time of use. The chondrocytes are delivered percutaneously under 2D-fluoroscopic guidance. The company anticipates that patients treated with NuQu will demonstrate faster recovery rates than traditional surgical approaches.
Phase II
In October the company announced the initiation of a Phase II clinical trial to further evaluate the efficacy and safety of the therapy. The company expects to commence enrollment in the randomized, double-blinded, placebo-controlled trial in the fourth quarter of 2012 at multiple U.S. clinical sites.
Mitchell Seyedin, Ph.D., president and CEO of the company said the results from the initial clinical experience with NuQu “support our belief that this technology may represent a breakthrough treatment for degenerative disc disease by promoting regeneration and healing of the disc. We believe that the publication of the 12-month data from our Phase I trial in a peer-reviewed journal validates our commitment to NuQu.” He added, “This technology has the potential to be a cost-effective non-surgical solution to disability from chronic low back pain and we believe that the results from our Phase II study, which includes a placebo control, will support this promise.”
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Discussion
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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