Phase II, Randomized, Double Blind, Placebo Controlled Study Evaluating the Treatment of Degenerative Lumbar Disc with Allogeneic Cultured Chondrocytes (NuQu)

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The objective of this Phase II study is to provide rigorous focus on the safety evaluation of NuQu, and to gather data regarding the efficacy of NuQu as compared to placebo control. The Investigational material (NuQu) consists of culture-expanded, human, juvenile chondrocytes provided in a cryopreservation solution.

Preclinical investigations have shown the absence of immunoreactivity and the potential of NuQu to produce cartilage, which is similar in characteristics to the native human disc. It is expected that NuQu will add to the available treatment armamentarium in the early to moderate stages of disc disease. Patients who have tried other non-surgical therapies such as physical therapy, chiropractic care, steroid injections, and pain medication will be appropriate candidates for NuQu injection. It is hoped that early treatment of degenerated intervertebral discs with NuQu may obviate the need for more invasive alternatives and prevent the expected cascade of structural dysfunction often associated with advancement of degenerative changes and surgical intervention.

PI: Roger Hartl, M.D.

Enrollment is now complete for this trial. Follow-up is continuing, but no additional patients will be accepted.

 

For more information, contact: Samantha Izat, RN, BSN, PCCN
Spine Center Coordinator
Phone: 212-746-7874
Fax: 212-746-8387