Lumbar Degenerative Disc DiseaseNCT02070484

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

A study testing NuCel and Demineralized Bone Matrix in people with Lumbar Degenerative Disc Disease and Spinal Stenosis, run by OhioHealth at 2 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: Lumbar Degenerative Disc Disease, Spinal Stenosis, Spondylolisthesis
What is being tested?: NuCel and Demineralized Bone Matrix
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 6 participants
Where: 2 sitesUnited States
Study dates: Feb 2014to 24 Mar 2017
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Show all 11Show fewer

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

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Riverside Methodist Hospital
Columbus, Ohio, 43214
Grant Medical Center
Columbus, Ohio, 43215

Other trials in United States

About this study

Official title: 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.

Conditions: Lumbar Degenerative Disc Disease, Spinal Stenosis, Spondylolisthesis, Spondylosis, Intervertebral Disk Displacement, Intervertebral Disk Degeneration
Being tested: NuCel, Demineralized Bone Matrix
Keywords: NuCel, Lumbar Spine, Degenerative Disease, Efficacy, Fusion
Medical subject headings: Intervertebral Disc Degeneration, Spinal Stenosis, Spondylolisthesis, Spondylosis, Intervertebral Disc Displacement, Spinal Diseases, Bone Diseases, Musculoskeletal Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

NuCelBiological
Demineralized Bone MatrixBiological

Study groups in NCT02070484
Study group	Role	What they receive
NuCel	Experimental	Stemcell allograft Receives: Biological: NuCel
Demineralized Bone Matrix (DBM)	Active comparator	Demineralized Bone Matrix (DBM) bone graft substitute Receives: Biological: Demineralized Bone Matrix

What is being measured

The primary outcome is the main question the study is designed to answer.

Oswestry Disability Index
The Oswestry Disability Index (ODI) measures disability on a scale of 0-100, where higher scores correspond to greater disability.
Measured: 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.
Measured: Baseline
Oswestry Disability Index
The Oswestry Disability Index (ODI) measures disability on a scale of 0-100, where higher scores correspond to greater disability.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 months

Secondary outcomes (1)

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.
Measured: 6 and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 201424 Mar 2017

First posted25 Feb 2014 (estimated)
Study startFeb 2014
Primary completion24 Mar 2017
Study completion24 Mar 2017

Why it stopped: Poor enrollment

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Lumbar Degenerative Disc DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 6 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02070484
Sponsor's protocol ID: OH2-13-0034
Status last verified: Aug 2018
First submitted: 21 Feb 2014
Last updated: 28 Sep 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
Post Marketing Study of MagnetOs Easypack Putty Standalone Compared to Demineralized Bone Matrix or Fibers Mixed With Autograft in Patients Undergoing Posterolateral Lumbar Fusion
Degenerative Disc Disease, Spine Fusion
Not yet recruitingObservational study
Relationship Between Disability, Flexibility, Back Muscles, and Thoracolumbar Fascia in Patients With Lumbar Disc Degeneration
Intervertebral Disc Degeneration
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ASCEND: A Clinical Trial to Evaluate the Safety and Effectiveness of VIA Disc NP, a Supplement for Degenerated Intervertebral Discs
Degenerative Disc Disease, Disc Degeneration
Not yet recruiting
Kore Fiber PLF Study
Degenerative Lumbar Spine Diseases, Lumbar Degenerative Disc Disease
Recruiting
MagnetOs Flex Matrix Compared to Trinity Elite Mixed With Local Autograft in Patients Undergoing up to Four-level Instrumented Posterolateral Fusion
Degenerative Disc Disease, Spine Fusion

All Lumbar Degenerative Disc Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy of a Human Amniotic Tissue-derived Allograft, NuCel, in Patients Undergoing Posteriolateral Lumbar Fusions for Degenerative Disc Disease
ClinicalTrials.gov ID: NCT02070484
Acronym / sponsor ID: OH2-13-0034
Conditions: Lumbar Degenerative Disc Disease, Spinal Stenosis, Spondylolisthesis, Spondylosis, Intervertebral Disk Displacement, Intervertebral Disk Degeneration
Keywords: NuCel, Lumbar Spine, Degenerative Disease, Efficacy, Fusion
Study type: Interventional
Recruitment status: TerminatedReason stopped: Poor enrollment
Enrolment: 6 participants (actual)
Lead sponsor: OhioHealthUniversity, hospital or other
Collaborators: NuTech Medical, Inc
Study start: Feb 2014
Primary completion: 24 Mar 2017 (actual)
Study completion: 24 Mar 2017 (actual)
First posted: 25 Feb 2014 (estimated)
Results: Posted 27 Aug 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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 design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 2

Arm	Type	Receives
NuCel	Experimental	Biological: NuCelStemcell allograft
Demineralized Bone Matrix (DBM)	Active comparator	Biological: Demineralized Bone MatrixDemineralized Bone Matrix (DBM) bone graft substitute

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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

Key exclusion criteria (11 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
NuCel	Biological	NuCel
Demineralized Bone Matrix	Biological	Demineralized Bone Matrix (DBM)

Primary outcome

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

1 secondary outcome

Computed Tomography (CT) Scans to Assess Lumbar Bone Fusion
Time frame: 6 and 12 months

Results and safety

Results posted to the registry on 27 Aug 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
NuCel	3	2
Demineralized Bone Matrix (DBM)	3	3

Primary outcome: Oswestry Disability Index

Time frame: 12 months. Mean (Standard Deviation). Unit: units on a scale

Measure	NuCel n = 2	Demineralized Bone Matrix (DBM) n = 3
Value	8.0 (11.3)	15.3 (17.2)

Population analysed: One of three NuCel patients withdrew before 12 months; therefore, analysis comprises two NuCel patients and three DBM patients.

Primary outcome: Oswestry Disability Index

Time frame: Baseline. Mean (Standard Deviation). Unit: units on a scale

Measure	NuCel n = 3	Demineralized Bone Matrix (DBM) n = 3
Value	28.7 (3.1)	26.7 (7.5)

Primary outcome: Oswestry Disability Index

Time frame: 1 month. Mean (Standard Deviation). Unit: units on a scale

Measure	NuCel n = 2	Demineralized Bone Matrix (DBM) n = 3
Value	15.5 (12.0)	26.7 (13.7)

Population analysed: One of three NuCel patients withdrew; therefore, analysis comprises two NuCel patients and three DBM patients.

Primary outcome: Oswestry Disability Index

Time frame: 2 months. Mean (Standard Deviation). Unit: units on a scale

Measure	NuCel n = 2	Demineralized Bone Matrix (DBM) n = 3
Value	19.5 (17.7)	22.0 (9.6)

Population analysed: One of three NuCel patients withdrew; therefore, analysis comprises two NuCel patients and three DBM patients.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse events were recorded through 12 months post-operatively. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
NuCel	0 of 3 (0%)	0 of 3 (0%)	0 of 3
Demineralized Bone Matrix (DBM)	1 of 3 (33.3%)	0 of 3 (0%)	0 of 3

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Lumbar Degenerative Disc Disease

Active, not recruiting
Post Marketing Study of MagnetOs Easypack Putty Standalone Compared to Demineralized Bone Matrix or Fibers Mixed With Autograft in Patients Undergoing Posterolateral Lumbar Fusion
Degenerative Disc Disease, Spine Fusion
Not yet recruitingObservational study
Relationship Between Disability, Flexibility, Back Muscles, and Thoracolumbar Fascia in Patients With Lumbar Disc Degeneration
Intervertebral Disc Degeneration
Active, not recruiting
ASCEND: A Clinical Trial to Evaluate the Safety and Effectiveness of VIA Disc NP, a Supplement for Degenerated Intervertebral Discs
Degenerative Disc Disease, Disc Degeneration
Not yet recruiting
Kore Fiber PLF Study
Degenerative Lumbar Spine Diseases, Lumbar Degenerative Disc Disease
Recruiting
MagnetOs Flex Matrix Compared to Trinity Elite Mixed With Local Autograft in Patients Undergoing up to Four-level Instrumented Posterolateral Fusion
Degenerative Disc Disease, Spine Fusion

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Joseph Shehadi, MD principal investigator

OhioHealth

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing NuCel and Demineralized Bone Matrix in people with Lumbar Degenerative Disc Disease and Spinal Stenosis, run by OhioHealth at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 28 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Aug 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Oswestry Disability Index (time frame: 12 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02070484.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2018.