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

Spinal Stenosis Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02023372
• Other study ID #: RD2013-11-07
• Status: Completed
• Phase: N/A
• Start date: December 2013
• Est. completion date: August 16, 2019

Study information

• Verified date: January 2020
• Source: NuTech Medical, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: August 16, 2019
• Est. primary completion date: August 16, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
United States	Carolina NeuroSurgery and Spine	Charlotte	North Carolina

Sponsors (4)

Lead Sponsor	Collaborator
NuTech Medical, Inc	Atrium Health, Carolina Neurosurgery & Spine Associates, Organogenesis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Spinal Fusion	CT scan will be used to evaluate fusion of one, two, or three levels	12 months
Secondary	Change from baseline pain using Visual Analogue Scale (VAS)		6 weeks, 3 months, 6 months, and 12 months
Secondary	Change from baseline Oswestry Disability Index (Ver. 2.1)		6 weeks, 3 months, 6 months, 12 months
Secondary	X-ray to compare to baseline preoperative X-ray		6 weeks, 3 months, 6 months, 12 months