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

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.

Study Overview

• Status: Terminated
• Conditions: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spinal Stenosis; Spondylosis; Spondylolisthesis; Spondylolysis; Lumbar Degenerative Disc Disease; Intervertebral Disk Degeneration; Intervertebral Disk Displacement
• Intervention / Treatment: Biological: NuCel; Biological: Demineralized Bone Matrix

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43214
      • Riverside Methodist Hospital
    • Columbus, Ohio, United States, 43215
      • Grant Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: NuCel; Stemcell allograft	Biological: NuCel
ACTIVE_COMPARATOR: Demineralized Bone Matrix (DBM); Demineralized Bone Matrix (DBM) bone graft substitute	Biological: Demineralized Bone Matrix

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oswestry Disability Index	The Oswestry Disability Index (ODI) measures disability on a scale of 0-100, where higher scores correspond to greater disability.	12 months
Oswestry Disability Index	The Oswestry Disability Index (ODI) measures disability on a scale of 0-100, where higher scores correspond to greater disability.	Baseline
Oswestry Disability Index	The Oswestry Disability Index (ODI) measures disability on a scale of 0-100, where higher scores correspond to greater disability.	1 month
Oswestry Disability Index	The Oswestry Disability Index (ODI) measures disability on a scale of 0-100, where higher scores correspond to greater disability.	2 months
Oswestry Disability Index	The Oswestry Disability Index (ODI) measures disability on a scale of 0-100, where higher scores correspond to greater disability.	3 months
Oswestry Disability Index	The Oswestry Disability Index (ODI) measures disability on a scale of 0-100, where higher scores correspond to greater disability.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Computed Tomography (CT) Scans to Assess Lumbar Bone Fusion	CT scans reviewed by an independent radiologist and scored according to three categories: no fusion, any fusion, solid fusion.	6 and 12 months

Collaborators and Investigators

• Sponsor: OhioHealth
• Collaborators: NuTech Medical, Inc
• Investigators: Principal Investigator: Joseph Shehadi, MD, OhioHealth

Study record dates

Study Major Dates

• Study Start: February 1, 2014
• Primary Completion (ACTUAL): March 24, 2017
• Study Completion (ACTUAL): March 24, 2017

Study Registration Dates

• First Submitted: February 21, 2014
• First Submitted That Met QC Criteria: February 21, 2014
• First Posted (ESTIMATE): February 25, 2014

Study Record Updates

• Last Update Posted (ACTUAL): September 28, 2018
• Last Update Submitted That Met QC Criteria: August 28, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Efficacy; Lumbar Spine; Fusion; NuCel; Degenerative Disease
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia; Intervertebral Disc Displacement; Intervertebral Disc Degeneration; Bone Diseases; Musculoskeletal Diseases; Spinal Diseases; Spinal Stenosis; Spondylosis; Spondylolisthesis; Spondylolysis
• Other Study ID Numbers: OH2-13-0034