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Viable Allograft Supplemented Disc Regeneration in the Treatment of Patients With Low Back Pain

NCT03709901 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 218

Last updated 2021-07-07

No results posted yet for this study

Summary

The objective of this study is to evaluate the safety and efficacy of viable allograft transplantation for the treatment of patients with symptomatic disc degeneration and tissue loss.

All subjects randomized to Active Allograft will undergo injection of a viable allograft into the nucleus pulposus of the degenerated disc. All subjects randomized to Placebo will undergo injection with saline into the nucleus pulposus of the degenerated disc. All subjects randomized to Conservative Care will continue standard of care, with the opportunity to crossover at 3 months into the Active Allograft arm.

Conditions

  • Degenerative Disc Disease

Interventions

OTHER

Active Allograft

Injection of viable allograft into the nucleus pulposus of the degenerated disc

OTHER

Placebo

Injection of sterile normal saline (0.9% sodium chloride) into the nucleus pulposus of the degenerated disc

Sponsors & Collaborators

  • VIVEX Biologics, Inc.

    lead INDUSTRY

Principal Investigators

  • Timothy Ganey, PhD · VIVEX Biologics, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-08-22
Primary Completion
2022-01-31
Completion
2022-01-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03709901 on ClinicalTrials.gov