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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.

What is the investigational product?

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:

  • Group 1 will receive injections of the VIA disc
  • Group 2 will receive placebo injections
  • Group 3 will receive non-operative care

Why is the VAST Study important?

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.

Symptoms of Disc Degeneration include:

  • Nagging to severe pain, especially in the lower back, buttocks, and thighs
  • Pain that gets worse with sitting, bending, lifting, or twisting.
  • Pain that comes and goes for days or months
  • Numbing and tingling in the feet

You may be eligible to participate in the VAST study if you:

  • Are ages 18-60
  • Have degenerative changes in one or two lumbar discs
  • Have had low back pain for at least six months

For more information: 972-608-5181 or 972-608-5065 (Texas Back Institute)