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

NuTech NuCel®: A Prospective, Efficacy Study of NuCel® in Patients Undergoing Fusion for One, Two or Three Level Degenerative Disease of the Lumbar Spine.

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

Study Overview

• Status: Completed
• Conditions: Intervertebral Disc Degeneration; Spinal Stenosis; Spondylosis; Spondylolisthesis; Intervertebral Disc Disease
• Intervention / Treatment: Other: NuCel with Autograft

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
• Enrollment (Actual): 57
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • Carolina NeuroSurgery and Spine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Spinal Fusion	CT scan will be used to evaluate fusion of one, two, or three levels	12 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: NuTech Medical, Inc
• Collaborators: Wake Forest University Health Sciences; Organogenesis; Carolina Neurosurgery & Spine Associates
• Investigators: Principal Investigator: Domagoj Coric, MD, Carolina Neurosurgery & Spine Associates

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (ACTUAL): August 16, 2019
• Study Completion (ACTUAL): August 16, 2019

Study Registration Dates

• First Submitted: December 23, 2013
• First Submitted That Met QC Criteria: December 23, 2013
• First Posted (ESTIMATE): December 30, 2013

Study Record Updates

• Last Update Posted (ACTUAL): January 18, 2020
• Last Update Submitted That Met QC Criteria: January 14, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Efficacy; Lumbar Spine; Fusion; NuCel; Degenerative Disease
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spondylolysis; Intervertebral Disc Degeneration; Spinal Stenosis; Spondylosis; Spondylolisthesis
• Other Study ID Numbers: RD2013-11-07

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No