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

NCT02023372 | Completed

• 1 other identifier: RD2013-11-07
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

NuCel; Lumbar Spine; Degenerative Disease; Efficacy; Fusion

Outcome Measures

Primary Outcomes (1)

• Spinal Fusion

  CT scan will be used to evaluate fusion of one, two, or three levels

  12 months

Secondary Outcomes (3)

• 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

Study Arms (1)

NuCel with Autograft

OTHER

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

Interventions

NuCel with Autograft OTHER

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.

NuCel with Autograft

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Must be diagnosed with degenerative disease of lumbar spine

You may not qualify if:

• 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.

Sponsors & Collaborators

• NuTech Medical, Inc: lead
• Carolina Neurosurgery & Spine Associates: collaborator
• Wake Forest University Health Sciences: collaborator
• Organogenesis: collaborator

Study Sites (1)

Carolina NeuroSurgery and Spine

Charlotte, North Carolina, 28204, United States

Location

MeSH Terms

Conditions

Intervertebral disc disease; Intervertebral Disc Degeneration; Spondylosis; Spondylolisthesis; Spinal Stenosis

Interventions

Transplantation, Autologous

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Spondylolysis

Intervention Hierarchy (Ancestors)

Transplantation; Surgical Procedures, Operative

Study Officials

• Domagoj Coric, MD

  Carolina Neurosurgery & Spine Associates

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2013
• First Posted: December 30, 2013
• Study Start: December 1, 2013
• Primary Completion: August 16, 2019
• Study Completion: August 16, 2019
• Last Updated: January 18, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)