Intervertebral Disc DiseaseNCT02023372
Efficacy Study of NuCel® in Patients Undergoing Fusion of the Lumbar Spine
A study testing NuCel with Autograft in people with Intervertebral Disc Disease and Intervertebral Disc Degeneration, run by NuTech Medical, Inc at 1 site in United States.
Trial summary
The purpose of this study is to determine whether NuCel is effective in promoting spinal fusion in degenerative disease of the lumbar spine. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Intervertebral Disc Disease, Intervertebral Disc Degeneration, Spondylosis
- What is being tested?
- NuCel with Autograft
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2013to 16 Aug 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must be diagnosed with degenerative disease of lumbar spine
Who cannot join
- Back pain due to injury
- Back pain that is caused by infection, cancer, lesions(growths) or bone disease such as osteoporosis
- Any terminal (will not recover from the disease) or autoimmune disease including but not limited to HIV infection, or rheumatoid arthritis
- Any other medical condition that might affect normal healing
- Less than 21 years of age
- More than three levels of fusion needed
Show all 12Show fewer
- Recent history (within past 6 months) of any chemical or alcohol dependence
- Morbid obesity (Body Mass Index of more than 40)
- Currently a prisoner
- Currently experiencing a major mental illness
- Pregnancy at the time of enrollment
- Previously diagnosed with diseases of the bone such as osteoporosis, osteopenia or osteomalacia (softening of the bones). Patients with any of the risk factors for osteoporosis may have DEXA scans performed prior to study entry.
Trial locations and contacts
1 site in 1 country.
United States1 site
Carolina NeuroSurgery and Spine
Charlotte, North Carolina, 28204
About this study
Official title: NuTech NuCel®: A Prospective, Efficacy Study of NuCel® in Patients Undergoing Fusion for One, Two or Three Level Degenerative Disease of the Lumbar Spine.
The purpose of this study is to determine whether NuCel is effective in promoting spinal fusion in degenerative disease of the lumbar spine.
Read the detailed description
The study is a prospective, single center clinical trial to establish the efficacy of NuCel, a minimally manipulated allograft tissue, for use in lumbar interbody and intertransverse fusion procedures. Subjects will undergo standard interbody fusion surgery as per the signed informed consent with NuCel and autograft bone. Patients will be evaluated postoperatively at 6 weeks, 3 months, 6 months, 1 year, and 2 years (if required).
- Conditions
- Intervertebral Disc Disease, Intervertebral Disc Degeneration, Spondylosis, Spondylolisthesis, Spinal Stenosis
- Being tested
- NuCel with Autograft
- Keywords
- NuCel, Lumbar Spine, Degenerative Disease, Efficacy, Fusion
- Medical subject headings
- Intervertebral disc disease, Intervertebral Disc Degeneration, Spondylosis, Spondylolisthesis, Spinal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NuCel with AutograftOther
NuCel is a minimally manipulated allograft product derived from amniotic membrane along with cells from amniotic fluid. Local autograft is bone that comes from the patient's own vertebrae and surrounding bony structures.
| Study group | Role | What they receive |
|---|---|---|
| NuCel with Autograft | Other | NuCel will be used with local autograft during surgical treatment of one, two or three level degenerative disease of the lumbar spine Receives: Other: NuCel with Autograft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Spinal Fusion
CT scan will be used to evaluate fusion of one, two, or three levels
Measured: 12 months
Secondary outcomes (3)
Change from baseline pain using Visual Analogue Scale (VAS)
Measured: 6 weeks, 3 months, 6 months, and 12 months
Change from baseline Oswestry Disability Index (Ver. 2.1)
Measured: 6 weeks, 3 months, 6 months, 12 months
X-ray to compare to baseline preoperative X-ray
Measured: 6 weeks, 3 months, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2013 (estimated)
- Study startDec 2013
- Primary completion16 Aug 2019
- Study completion16 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intervertebral 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- NuTech Medical, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Carolina Neurosurgery & Spine Associates, Wake Forest University Health Sciences, Organogenesis
- Responsible party
- Sponsor
- Investigators
- Domagoj Coric, MD, Principal investigator, Carolina Neurosurgery & Spine Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02023372
- Sponsor's protocol ID
- RD2013-11-07
- Status last verified
- Jan 2020
- First submitted
- 23 Dec 2013
- Last updated
- 18 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NuTech NuCel®: A Prospective, Efficacy Study of NuCel® in Patients Undergoing Fusion for One, Two or Three Level Degenerative Disease of the Lumbar Spine.
- ClinicalTrials.gov ID
- NCT02023372
- Acronym / sponsor ID
- RD2013-11-07
- Conditions
- Intervertebral Disc Disease, Intervertebral Disc Degeneration, Spondylosis, Spondylolisthesis, Spinal Stenosis
- Keywords
- NuCel, Lumbar Spine, Degenerative Disease, Efficacy, Fusion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- NuTech Medical, IncIndustry (pharma, biotech, devices)
- Collaborators
- Carolina Neurosurgery & Spine Associates, Wake Forest University Health Sciences, Organogenesis
- Study start
- Dec 2013
- Primary completion
- 16 Aug 2019 (actual)
- Study completion
- 16 Aug 2019 (actual)
- First posted
- 30 Dec 2013 (estimated)
- Results
- Not posted in the source record
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 determine whether NuCel is effective in promoting spinal fusion in degenerative disease of the lumbar spine.
Detailed description
The study is a prospective, single center clinical trial to establish the efficacy of NuCel, a minimally manipulated allograft tissue, for use in lumbar interbody and intertransverse fusion procedures. Subjects will undergo standard interbody fusion surgery as per the signed informed consent with NuCel and autograft bone. Patients will be evaluated postoperatively at 6 weeks, 3 months, 6 months, 1 year, and 2 years (if required).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NuCel with Autograft | Other | Other: NuCel with AutograftNuCel will be used with local autograft during surgical treatment of one, two or three level degenerative disease of the lumbar spine |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Must be diagnosed with degenerative disease of lumbar spine
Key exclusion criteria (12 listed)
- Back pain due to injury
- Back pain that is caused by infection, cancer, lesions(growths) or bone disease such as osteoporosis
- Any terminal (will not recover from the disease) or autoimmune disease including but not limited to HIV infection, or rheumatoid arthritis
- Any other medical condition that might affect normal healing
- Less than 21 years of age
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 with AutograftNuCel is a minimally manipulated allograft product derived from amniotic membrane along with cells from amniotic fluid. Local autograft is bone that comes from the patient's own vertebrae and surrounding bony structures. | Other | NuCel with Autograft |
Primary outcome
Spinal Fusion
Time frame: 12 months
CT scan will be used to evaluate fusion of one, two, or three levels
3 secondary outcomes
Change from baseline pain using Visual Analogue Scale (VAS)
Time frame: 6 weeks, 3 months, 6 months, and 12 months
Change from baseline Oswestry Disability Index (Ver. 2.1)
Time frame: 6 weeks, 3 months, 6 months, 12 months
X-ray to compare to baseline preoperative X-ray
Time frame: 6 weeks, 3 months, 6 months, 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2020.
- Individual participant dataSharing planned: No
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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.
Domagoj Coric, MD principal investigator
Carolina Neurosurgery & Spine Associates
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NuCel with Autograft in people with Intervertebral Disc Disease and Intervertebral Disc Degeneration, run by NuTech Medical, Inc at 1 site 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 1 inclusion and 12 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: finished, as of the sponsor's last update on 18 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Spinal Fusion (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jan 2020.