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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2019-08-16

Brief Summary

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

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Detailed Description

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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).

Conditions

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Intervertebral Disc Disease Intervertebral Disc Degeneration Spondylosis Spondylolisthesis Spinal Stenosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type OTHER

NuCel with Autograft

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No