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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02070484
Recruitment Status : Completed
First Posted : February 25, 2014
Last Update Posted : September 15, 2017
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

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 identifier (NCT number): NCT02070484

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

Responsible Party: Joseph A. Shehadi, MD, Principal Investigator, OhioHealth 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:
Lumbar Spine
Degenerative Disease

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