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A Prospective Study of NuCel® in Cervical Spine Fusion

NCT02381067 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 61

Last updated 2020-01-18

No results posted yet for this study

Summary

The study is intended to demonstrate that the NuCel® allograft is effective and safe in promoting bone growth and fusion rate when used in cervical fusion in patients with one, two or three-level diseases of the cervical spine.

Conditions

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

Interventions

OTHER

NuCel with Allograft Bone

NuCel is a minimally manipulated allograft product derived from amniotic membrane along with cells from amniotic fluid. Allograft bone is bone that comes another patient. NuCel and Allograft bone will be combined for this treatment.

Sponsors & Collaborators

  • NuTech Medical, Inc

    lead INDUSTRY

Principal Investigators

  • Franklin Lin, M.D. · Wellstar Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2016-12-01
Completion
2016-12-15

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 NCT02381067 on ClinicalTrials.gov