Clinical Trial Evaluating the Safety and Efficacy of Nucleus Pulposus Allograft in Participants With Degenerative Disc Disease

Part of paid clinical trials in Napa, California.

Sponsor
VIVEX Biologics, Inc.
Study ID
NCT06778447
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
22 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • VIA Disc NP — OTHER
    VIA Disc NP is processed from donated cadaveric disc tissue, lyophilized, and micronized to particles.
  • Sham — OTHER
    A 20G spinal needle will be carefully inserted through the skin and muscle of the back but WILL NOT penetrate the annulus fibrosus of the intervertebral disc. No saline or VIA Disc NP will be injected.

Study Details

VIA Disc NP is a non-surgical intervention intended to supplement nucleus pulposus tissue in degenerated intervertebral discs. This is a randomized, sham-controlled, multi-center, double-blind clinical trial with an open label roll-in period of one participant per site in which participants with lumbar discogenic pain associated with DDD will receive one VIA Disc NP treatment to each affected level (up to 2 levels). Participants enrolled after the roll-in stage will be randomized on a 2:1 basis to receive either a single VIA Disc NP intradiscal injection at 1 or 2 levels or the sham procedure at 1 or 2 levels. At 12 months, participants in the sham arm with continued symptoms may cross-over, receive VIA Disc NP, and will restart the study visit schedule, completing an additional 12 months of follow-up post-cross-over.

Key Dates

Start date
Feb 17, 2025
Status verified
Apr 2026
Primary completion
May 31, 2027
Completion
May 31, 2028

Study Design

Enrollment
496 participants (estimated)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Experimental: VIA Disc NP
    A single dose, intradiscal delivery of 100mg of VIA Disc NP mixed with sterile saline according to product Instructions for Use (IFU) and administered at up to two affected levels, L1-S1.
  • Sham Comparator: Sham
    The procedure will be identical to the investigational procedure with the following exception: A 20G spinal needle will be carefully inserted through the skin and muscle of the back but WILL NOT penetrate the annulus fibrosus of the intervertebral disc. No saline or VIA Disc NP will be injected.

Primary Outcome Measure

Primary Effectiveness Endpoint - Proportion of participants achieving MCID in VAS score from baseline to 12 months. [ Time Frame: Baseline to 12 Months ]

Central Contacts

Locations (19)

FacilityCityStateZIPSite coordinators
Interventional Pain Management Napa Valley Orthopedic Medical GroupNapaCalifornia94558
Jackie Weisbein, MD (PRINCIPAL_INVESTIGATOR)
Source HealthcareSanta MonicaCalifornia90403
Gabriel Wirnowski
Tim Davis, MD (PRINCIPAL_INVESTIGATOR)
Premier Spine and Pain InstituteThorntonColorado80229
Dennis Dickman
Amar Patel, MD (PRINCIPAL_INVESTIGATOR)
The Orthopaedic InstituteGainesvilleFlorida32607
Ajay Antony, MD (PRINCIPAL_INVESTIGATOR)
Georgia Pain ManagementWoodstockGeorgia30189
Tina Hall
James Ellner, MD (PRINCIPAL_INVESTIGATOR)
Henry Community HealthNew CastleIndiana47362
Rebecca Layman
Andrew Davisson, MD (PRINCIPAL_INVESTIGATOR)
University of KansasKansas CityKansas66160
Karina Bravo
Usman Latif, MD (PRINCIPAL_INVESTIGATOR)
University of KentuckyLexingtonKentucky40504
Katie Eastridge
Christopher Mallard, MD (PRINCIPAL_INVESTIGATOR)
Ochsner Clinic FoundationNew OrleansLouisiana70115
Maged Guirguis, MD (PRINCIPAL_INVESTIGATOR)
Spine Institute of LouisianaShreveportLouisiana71101
Krista Kachnik
Pierce Nunley, MD (PRINCIPAL_INVESTIGATOR)
Paradigm Health SystemSlidellLouisiana70458
Chris Myers
Thomas Myers, MD (PRINCIPAL_INVESTIGATOR)
Nevada Advanced Pain SpecialistsRenoNevada89511
Madeline Benson
Denis Patterson, DO (PRINCIPAL_INVESTIGATOR)
Premier Pain CentersShrewsburyNew Jersey07702
Kathryn Gee
Sean Li, MD (PRINCIPAL_INVESTIGATOR)
Northwell HealthNew YorkNew York10019
Jarka Faruq
Kiran Patel, MD (PRINCIPAL_INVESTIGATOR)
Crystal Coast Pain ManagementNew BernNorth Carolina28560
Amy Harum
Kirk Harum, MD (PRINCIPAL_INVESTIGATOR)
Pacific Sports & SpineEugeneOregon97404
Katie Fabian
Greg Moore, MD (PRINCIPAL_INVESTIGATOR)
Procura Pain & SpineShenandoahTexas77384
Courtney Harvey
Thomas White, MD (PRINCIPAL_INVESTIGATOR)
Precision Spine CareTylerTexas75701
Jessica Youngblood
Aaron Calodney, MD (PRINCIPAL_INVESTIGATOR)
The Spine and Nerve Center C/O Clinical ResearchCharlestonWest Virginia25301
Amy Young, RN
[email protected]
304-347-6144
Tim Deer, National PI, MD (PRINCIPAL_INVESTIGATOR)

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