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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by NuCel, LLC
Sponsor:
Collaborators:
Carolina Neurosurgery & Spine Associates
Carolinas Healthcare System
Information provided by (Responsible Party):
NuCel, LLC
ClinicalTrials.gov Identifier:
NCT02023372
First received: December 23, 2013
Last updated: September 23, 2014
Last verified: September 2014
  Purpose

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


Condition Intervention
Intervertebral Disc Disease
Intervertebral Disc Degeneration
Spondylosis
Spondylolisthesis
Spinal Stenosis
Other: NuCel with Autograft

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: NuTech NuCel®: A Prospective, Efficacy Study of NuCel® in Patients Undergoing Fusion for One, Two or Three Level Degenerative Disease of the Lumbar Spine.

Resource links provided by NLM:


Further study details as provided by NuCel, LLC:

Primary Outcome Measures:
  • Spinal Fusion [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    CT scan will be used to evaluate fusion of one, two, or three levels


Secondary Outcome Measures:
  • Change from baseline pain using Visual Analogue Scale (VAS) [ Time Frame: 6 weeks, 3 months, 6 months, and 12 months ] [ Designated as safety issue: No ]
  • Change from baseline Oswestry Disability Index (Ver. 2.1) [ Time Frame: 6 weeks, 3 months, 6 months, 12 months ] [ Designated as safety issue: No ]
  • X-ray to compare to baseline preoperative X-ray [ Time Frame: 6 weeks, 3 months, 6 months, 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: December 2013
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NuCel with Autograft
NuCel will be used with local autograft during surgical treatment of one, two or three level degenerative disease of the lumbar spine
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.

Detailed Description:

The study is a prospective, single center clinical trial to establish the efficacy of NuCel, a minimally manipulated allograft tissue, for use in lumbar interbody and intertransverse fusion procedures. Subjects will undergo standard interbody fusion surgery as per the signed informed consent with NuCel and autograft bone. Patients will be evaluated postoperatively at 6 weeks, 3 months, 6 months, 1 year, and 2 years (if required).

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Must be diagnosed with degenerative disease of lumbar spine

Exclusion Criteria:

  • Back pain due to injury
  • Back pain that is caused by infection, cancer, lesions(growths) or bone disease such as osteoporosis
  • Any terminal (will not recover from the disease) or autoimmune disease including but not limited to HIV infection, or rheumatoid arthritis
  • Any other medical condition that might affect normal healing
  • Less than 21 years of age
  • More than three levels of fusion needed
  • Recent history (within past 6 months) of any chemical or alcohol dependence
  • Morbid obesity (Body Mass Index of more than 40)
  • Currently a prisoner
  • Currently experiencing a major mental illness
  • Pregnancy at the time of enrollment
  • Previously diagnosed with diseases of the bone such as osteoporosis, osteopenia or osteomalacia (softening of the bones). Patients with any of the risk factors for osteoporosis may have DEXA scans performed prior to study entry.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02023372

Locations
United States, North Carolina
Carolina NeuroSurgery and Spine Recruiting
Charlotte, North Carolina, United States, 28204
Contact: Domagoj Coric, MD    704-376-1605    peggy.boltes@cnsa.com   
Principal Investigator: Dom Coric, MD         
Sponsors and Collaborators
NuCel, LLC
Carolina Neurosurgery & Spine Associates
Carolinas Healthcare System
Investigators
Principal Investigator: Domagoj Coric, MD Carolina Neurosurgery & Spine Associates
  More Information

No publications provided

Responsible Party: NuCel, LLC
ClinicalTrials.gov Identifier: NCT02023372     History of Changes
Other Study ID Numbers: RD2013-11-07
Study First Received: December 23, 2013
Last Updated: September 23, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by NuCel, LLC:
NuCel
Lumbar Spine
Degenerative Disease
Efficacy
Fusion

Additional relevant MeSH terms:
Spondylolisthesis
Intervertebral Disc Degeneration
Intervertebral Disc Displacement
Spinal Stenosis
Spondylosis
Bone Diseases
Hernia
Musculoskeletal Diseases
Pathological Conditions, Anatomical
Spinal Diseases
Spondylolysis

ClinicalTrials.gov processed this record on October 21, 2014