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

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ClinicalTrials.gov Identifier: NCT02070484
Recruitment Status : Completed
First Posted : February 25, 2014
Last Update Posted : September 15, 2017
Sponsor:
Collaborator:
NuTech Medical, Inc
Information provided by (Responsible Party):
Joseph A. Shehadi, MD, 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.

Condition or disease Intervention/treatment Phase
Lumbar Degenerative Disc Disease Spinal Stenosis Spondylolisthesis Spondylosis Intervertebral Disk Displacement Intervertebral Disk Degeneration Spinal Diseases Bone Diseases Musculoskeletal Diseases Spondylolysis Biological: NuCel Biological: Demineralized Bone Matrix Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Efficacy of a Human Amniotic Tissue-derived Allograft, NuCel, in Patients Undergoing Posteriolateral Lumbar Fusions for Degenerative Disc Disease
Study Start Date : February 2014
Actual Primary Completion Date : March 24, 2017
Actual Study Completion Date : March 24, 2017

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Oswestry Disability Index [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Radiological [ Time Frame: 12 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02070484


Locations
United States, Ohio
Riverside Methodist Hospital
Columbus, Ohio, United States, 43214
Grant Medical Center
Columbus, Ohio, United States, 43215
Sponsors and Collaborators
OhioHealth
NuTech Medical, Inc
Investigators
Principal Investigator: Joseph Shehadi, MD OhioHealth

Responsible Party: Joseph A. Shehadi, MD, Principal Investigator, OhioHealth
ClinicalTrials.gov Identifier: NCT02070484     History of Changes
Other Study ID Numbers: OH2-13-0034
First Posted: February 25, 2014    Key Record Dates
Last Update Posted: September 15, 2017
Last Verified: September 2017

Keywords provided by Joseph A. Shehadi, MD, OhioHealth:
NuCel
Lumbar Spine
Degenerative Disease
Efficacy
Fusion

Additional relevant MeSH terms:
Spinal Diseases
Spinal Stenosis
Intervertebral Disc Degeneration
Bone Diseases
Spondylolisthesis
Musculoskeletal Diseases
Spondylosis
Intervertebral Disc Displacement
Spondylolysis
Hernia
Pathological Conditions, Anatomical