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Efficacy Study of NuCel® in Patients Undergoing Fusion of the Lumbar Spine

NCT02023372 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 57

Last updated 2020-01-18

No results posted yet for this study

Summary

The purpose of this study is to determine whether NuCel is effective in promoting spinal fusion in degenerative disease of the lumbar spine.

Conditions

  • Intervertebral Disc Disease
  • Intervertebral Disc Degeneration
  • Spondylosis
  • Spondylolisthesis
  • Spinal Stenosis

Interventions

OTHER

NuCel with Autograft

NuCel is a minimally manipulated allograft product derived from amniotic membrane along with cells from amniotic fluid. Local autograft is bone that comes from the patient's own vertebrae and surrounding bony structures.

Sponsors & Collaborators

  • Carolina Neurosurgery & Spine Associates

    collaborator OTHER

  • Wake Forest University Health Sciences

    collaborator OTHER

  • Organogenesis

    collaborator INDUSTRY

  • NuTech Medical, Inc

    lead INDUSTRY

Principal Investigators

  • Domagoj Coric, MD · Carolina Neurosurgery & Spine Associates

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-12-31
Primary Completion
2019-08-16
Completion
2019-08-16

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 NCT02023372 on ClinicalTrials.gov