Human Amniotic Tissue-derived Allograft, NuCel, in Posteriolateral Lumbar Fusions for Degenerative Disc Disease

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2017-03-24

Brief Summary

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The purpose of this study is to compare the effect and safety of NuCel to DBX on patients undergoing posteriolateral lumbar spinal fusions for degenerative disc disease.

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Detailed Description

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Conditions

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Lumbar Degenerative Disc Disease Spinal Stenosis Spondylolisthesis Spondylosis Intervertebral Disk Displacement Intervertebral Disk Degeneration Spinal Diseases Bone Diseases Musculoskeletal Diseases Spondylolysis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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NuCel

Stemcell allograft

Group Type EXPERIMENTAL

NuCel

Intervention Type BIOLOGICAL

Demineralized Bone Matrix (DBM)

Demineralized Bone Matrix (DBM) bone graft substitute

Group Type ACTIVE_COMPARATOR

Demineralized Bone Matrix

Intervention Type BIOLOGICAL

Interventions

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NuCel

Intervention Type BIOLOGICAL

Demineralized Bone Matrix

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Between the ages of 18 and 75 years
* Symptomatic, single-level degenerative lumbar disc disease, spondylosis or spondylolisthesis
* Failed conservative treatments
* Low risk for non-union
* Must be candidates for single-level, posteriolateral lumbar spine fusion
* Must be able and willing to give Informed Consent
* English-speaking

Exclusion Criteria

* Smoker (any smoking ≤3 months prior to consent); (Patel et al. 2013)
* Patients with poorly controlled diabetes mellitus (HgbA1c \> 7%)
* Documented osteoporosis
* Prior lumbar spinal surgery at the same spinal level, or immediately adjacent spine level, to the level being operated on
* Back pain due to infection, tumour, or metabolic bone disease
* Terminal disease, such as HIV infection, neoplasm
* Autoimmune disease, such as rheumatoid arthritis
* Morbid obesity (body mass index (BMI) of 35 kg/m2)
* Major psychiatric illness in the last year
* History of alcohol or drug abuse in the last year
* Pregnant women

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No