This is a clinical study to collect safety and preliminary efficiency information on the use of NuQu chondrocytes (cartilage cells) delivered to the center of a lumbar spinal disc to treat low back pain.
This is a Phase II clinical study to collect additional safety data and preliminary efficiency of juvenile chondrocytes, delivered in fibrin carrier (NuQu®) to the nucleus of lumbar intervertebral discs for the treatment of discogenic pain. This to be accomplished through a double blinded, placebo-controlled study of clinically meaningful endpoints including validated, subject reported outcomes of pain and disability, health related quality of life and subject satisfaction with treatment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
44
Alabama Orthopedic and Spine Center
Birmingham, Alabama, United States
California Spine Diagnostics
San Francisco, California, United States
The Spine Institute, Center for Spinal Restoration
Santa Monica, California, United States
Oswestry Disability Index
Time frame: 12 months
Subject Satisfaction as measured by subject's willingness to have the same procedure for the same condition
Success to be measured by the response of "Definitely True" or "Mostly True" to the following: "All things considered I would have the treatment again for the same condition".
Time frame: 24 Months
MRI
Time frame: 24 Months
Visual Analog Scale
Time frame: 24 Months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Ortho Georgia
Macon, Georgia, United States
Tufts University School of Medicine
Newton, Massachusetts, United States
Weill Cornell Medical College
New York, New York, United States
Carolina Neurosurgery and Spine Associates
Charlotte, North Carolina, United States
The NeuroSpine Institute
Eugene, Oregon, United States
Spine Team Texas
Southlake, Texas, United States
Spinal Reseach Foundation
Reston, Virginia, United States