VAST Clinical Trial: Safely Supplementing Tissue Lost to Degenerative Disc Disease

The study consisted of 2 phases: a screening phase (enrollment) followed by the active phase (12 months). As outlined, there was an indeterminate overlap of up to 2 weeks between the end of the screening phase and the start of the active phase for individual subjects. Subjects met entry criteria for both phases to be eligible and 2 weeks' opportunity was allowed for the subjects to evaluate the protocol and consent to their participation. Although 2 weeks were provided, subjects were eligible following their consent documentation being reviewed and received.

Subjects participating in the VAST Trial were randomized at 3.5:1:1 to receive a supplemental allograft (VIA Disc Matrix), saline as a placebo, or to continue under nonsurgical management (NSM). The assignment of the subjects to treatment (viable matrix supplement, saline placebo, or standard of care) was performed in a randomized manner after informed consent has been obtained.

Reduction in pain was evident in both of the active treatment groups in the study. Subjects who had been randomized to continue nonsurgical management (NSM) demonstrated no relief. The NSM subjects were further evaluated at 3 months (vertical dashed line), and unable to continue, all subjects crossed over to VIA Disc Tissue Matrix. Their response followed the trajectory of the active arms of the study and outcome demonstrated the largest improvement. One subject in the saline-treated group could not continue the study, and after 6 months crossed over to VIA Disc. The horizontal dashed line reflects that progress averaged into the small (4 subjects) placebo group. All patients receiving the randomized allograft completed the study in their cohort. In total, 21 of 24 subjects received the VIA Disc Tissue Matrix either randomized or open label.

Functional improvement was evident in both of the active treatment groups in the study. Subjects who had been randomized to continue nonsurgical (NSM) demonstrated no improvement. The NSM subjects were further evaluated at 3 months (vertical dashed line), and unable to continue, all subjects crossed over to VIA Disc Tissue Matrix. Their response followed the trajectory of the active arms of the study and outcome demonstrated the largest improvement. One subject in the saline-treated group could not continue the study, and after 6 months crossed over to VIA Disc. The horizontal dashed line reflects that progress averaged into the small (4 subjects) placebo group. All patients receiving the randomized allograft completed the study in their cohort. In total, 21 of 24 subjects received the VIA Disc Tissue Matrix either randomized or open label.

MRI images were used to qualify patients for inclusion in the study. Modified Pfirrmann scores between 3 and 6 were acceptable evaluations for participation. Signal intensity and morphologic distinction in the nucleus are noted. More important, pain reduction and functional improvement supported patient satisfaction in the treatment.