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

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ClinicalTrials.gov Identifier: NCT02023372
Recruitment Status : Active, not recruiting
First Posted : December 30, 2013
Last Update Posted : April 4, 2018
Sponsor:
Collaborators:
Carolina Neurosurgery & Spine Associates
Carolinas Healthcare System
Information provided by (Responsible Party):
NuTech Medical, Inc

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

Condition or disease Intervention/treatment Phase
Intervertebral Disc Disease Intervertebral Disc Degeneration Spondylosis Spondylolisthesis Spinal Stenosis Biological: NuCel with Autograft Not Applicable

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).

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 57 participants
Intervention Model: Single Group Assignment
Masking: None (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.
Study Start Date : December 2013
Actual Primary Completion Date : March 2018
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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
Biological: 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.



Primary Outcome Measures :
  1. Spinal Fusion [ Time Frame: 12 months ]
    CT scan will be used to evaluate fusion of one, two, or three levels


Secondary Outcome Measures :
  1. Change from baseline pain using Visual Analogue Scale (VAS) [ Time Frame: 6 weeks, 3 months, 6 months, and 12 months ]
  2. Change from baseline Oswestry Disability Index (Ver. 2.1) [ Time Frame: 6 weeks, 3 months, 6 months, 12 months ]
  3. X-ray to compare to baseline preoperative X-ray [ Time Frame: 6 weeks, 3 months, 6 months, 12 months ]


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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02023372


Locations
United States, North Carolina
Carolina NeuroSurgery and Spine
Charlotte, North Carolina, United States, 28204
Sponsors and Collaborators
NuTech Medical, Inc
Carolina Neurosurgery & Spine Associates
Carolinas Healthcare System
Investigators
Principal Investigator: Domagoj Coric, MD Carolina Neurosurgery & Spine Associates

Responsible Party: NuTech Medical, Inc
ClinicalTrials.gov Identifier: NCT02023372     History of Changes
Other Study ID Numbers: RD2013-11-07
First Posted: December 30, 2013    Key Record Dates
Last Update Posted: April 4, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by NuTech Medical, Inc:
NuCel
Lumbar Spine
Degenerative Disease
Efficacy
Fusion

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