This study is designed to determine whether VIA Disc is safe and effective in treating low back pain by attempting to repair damaged spinal discs via regenerative therapy. It will be compared with placebo (which does not have any active treatment), and non-operative care.
This study will recruit from study centers in the United States and the study will last about 18 months.
The investigational product is given as an injection into the center of the damaged intervertebral disc that is causing back pain.
It uses a tissue therapy that includes the implantation of allograft nucleus pulposus matrix that contains stem cells to supplement the patient’s own nucleus, potentially restoring the cushioning, support of the intervertebral disc.
Eligible patients will be randomly assigned (like drawing straws) to one of the three groups:
Degenerative Disc Disease in an age-related phenomenon affecting the intervertebral discs. These discs are spacers that act as cushions between the bones of the spine. As we age, the discs dry out, tear and become depressed. Degenerative Disc Disease can be quite painful, limiting mobility, and affecting quality of life.