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

Efficacy of a Human Amniotic Tissue-derived Allograft, NuCel, in Patients Undergoing Posteriolateral Lumbar Fusions for Degenerative Disc Disease

Sponsors

Lead Sponsor: OhioHealth

Collaborator: NuTech Medical, Inc

Source OhioHealth
Brief Summary

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.

Overall Status Terminated
Start Date 2014-02-01
Completion Date 2017-03-24
Primary Completion Date 2017-03-24
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Oswestry Disability Index 12 months
Oswestry Disability Index Baseline
Oswestry Disability Index 1 month
Oswestry Disability Index 2 months
Oswestry Disability Index 3 months
Oswestry Disability Index 6 months
Secondary Outcome
Measure Time Frame
Computed Tomography (CT) Scans to Assess Lumbar Bone Fusion 6 and 12 months
Enrollment 6
Condition
Intervention

Intervention Type: Biological

Intervention Name: NuCel

Arm Group Label: NuCel

Intervention Type: Biological

Intervention Name: Demineralized Bone Matrix

Arm Group Label: Demineralized Bone Matrix (DBM)

Eligibility

Criteria:

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

Gender:

All

Minimum Age:

18 Years

Maximum Age:

75 Years

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Joseph Shehadi, MD Principal Investigator OhioHealth
Location
Facility:
Riverside Methodist Hospital | Columbus, Ohio, 43214, United States
Grant Medical Center | Columbus, Ohio, 43215, United States
Location Countries

United States

Verification Date

2018-08-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: OhioHealth

Investigator Full Name: Joseph A. Shehadi, MD

Investigator Title: Principal Investigator

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: NuCel

Type: Experimental

Description: Stemcell allograft

Label: Demineralized Bone Matrix (DBM)

Type: Active Comparator

Description: Demineralized Bone Matrix (DBM) bone graft substitute

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Single (Participant)

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