SpondylosisNCT02381067
A Prospective Study of NuCel® in Cervical Spine Fusion
A study testing NuCel with Allograft Bone in people with Spondylosis and Spinal Stenosis, run by NuTech Medical, Inc at 1 site in United States.
Trial summary
The study is intended to demonstrate that the NuCel® allograft is effective and safe in promoting bone growth and fusion rate when used in cervical fusion in patients with one, two or three-level diseases of the cervical spine. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Spondylosis, Spinal Stenosis, Spondylolisthesis
- What is being tested?
- NuCel with Allograft Bone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2015to 15 Dec 2016
- 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
- Be at least 21 years of age
- Have clinical and radiological evidence of degenerative disc disease, spondylosis, spinal stenosis, or spondylolisthesis at either one, two or three levels of cervical spine.
- In the opinion of the treating surgeon, must already be a qualified candidate for cervical fusion surgery.
- Be likely to return for regular follow-ups until the end of the study period.
- Be willing and able to provide Informed Consent for study participation.
Who cannot join
- Neck pain due to acute trauma.
- Clinical, laboratory and/or radiological evidence of neck pain secondary to acute or chronic infection, malignancy, other space occupying lesions and metabolic bone demineralization diseases (e.g. osteomalacia, gout, Paget's disease etc.).
- Any terminal or autoimmune disease including but not limited to HIV infection, or rheumatoid arthritis.
- Any other concurrent medical disease or treatment that might significantly impair normal healing process as evaluated by the PI.
- Recent history (within past 6 months) of any chemical or alcohol dependence requiring treatment.
- Currently a prisoner.
Show all 9Show fewer
- Currently experiencing a major mental illness (psychosis, schizophrenia, major affective disorder) which may indicate that the symptoms are psychological rather than of physical origin.
- Pregnancy at the time of enrollment.
- In order to confirm eligibility, subjects previously diagnosed with osteoporosis, osteopenia or osteomalacia, female subjects over the age of 65, post-menopausal female subjects under the age of 65 with any of the risk factors for osteoporosis, and subjects at the investigator's discretion will have DEXA scans performed prior to study entry. If DEXA is required, exclusion will be defined as a DEXA bone density measurement T score ≤ -2.5
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Efficacy Study of NuCel® in Patients Undergoing Fusion for One, Two or Three Level Degenerative Disease of the Cervical Spine
The study is intended to demonstrate that the NuCel® allograft is effective and safe in promoting bone growth and fusion rate when used in cervical fusion in patients with one, two or three-level diseases of the cervical spine.
Read the detailed description
The study is intended to demonstrate that the NuCel® allograft is effective and safe in promoting bone growth and fusion rate when used in cervical fusion in patients with one, two or three-level diseases of the cervical spine. Sixty subjects will participate in the study at a single clinical site. Participants will be at least 21 years of age. All subjects will have been established with cervical spine disease at one, two or three levels of the cervical spine that requires cervical interbody fusion per the opinion of the treating surgeon. The primary objective is to demonstrate that NuCel® is comparable to autograft bone graft in producing a successful, contiguous fusion at 6 months ±4 weeks post-operative when used in cervical fusion surgery. Success based on findings of cervical CT scan and plain radiographs. Additionally, Visual Analog Scale (VAS), Neck Disability Index (NDI) and patient satisfaction will be used as secondary outcome measures.
- Conditions
- Spondylosis, Spinal Stenosis, Spondylolisthesis, Intervertebral Disc Disease, Intervertebral Disc Degeneration
- Being tested
- NuCel with Allograft Bone
- Keywords
- Cervical Fusion, NuCel, Amniotic Allograft, Prospective
- Medical subject headings
- Spondylosis, Spinal Stenosis, Spondylolisthesis, Intervertebral disc disease, Intervertebral Disc Degeneration, Klippel-Feil Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NuCel with Allograft BoneOther
NuCel is a minimally manipulated allograft product derived from amniotic membrane along with cells from amniotic fluid. Allograft bone is bone that comes another patient. NuCel and Allograft bone will be combined for this treatment.
| Study group | Role | What they receive |
|---|---|---|
| NuCel with Allograft Bone | Other | NuCel will be used with allograft bone for the surgical treatment of one, two or three level degenerative disease of the cervical spine. Receives: Other: NuCel with Allograft Bone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interbody Fusion measured using CT scans and standard radiographs
Interbody fusion will be measured using CT scans and standard radiographs
Measured: 6 months
Secondary outcomes (3)
Change from baseline pain using Visual Analogue Scale (VAS)
Measured: 6 weeks, 3 months, 6 months, 1 year
Change from baseline Neck Disability Index (NDI)
Measured: 6 weeks, 3 months, 6 months, 1 year
Patient Satisfaction Survey
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2015 (estimated)
- Study startMar 2015
- Primary completion1 Dec 2016
- Study completion15 Dec 2016
Why it stopped: Departure of PI from the study facility
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SpondylosisStudies 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
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- NuTech Medical, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Franklin Lin, M.D., Principal investigator, Wellstar Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02381067
- Sponsor's protocol ID
- RD2015-01-01
- Status last verified
- Jan 2020
- First submitted
- 2 Mar 2015
- Last updated
- 18 Jan 2020
- Results posted
- No
- Data monitoring committee
- 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
- A Prospective, Efficacy Study of NuCel® in Patients Undergoing Fusion for One, Two or Three Level Degenerative Disease of the Cervical Spine
- ClinicalTrials.gov ID
- NCT02381067
- Acronym / sponsor ID
- RD2015-01-01
- Conditions
- Spondylosis, Spinal Stenosis, Spondylolisthesis, Intervertebral Disc Disease, Intervertebral Disc Degeneration
- Keywords
- Cervical Fusion, NuCel, Amniotic Allograft, Prospective
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Departure of PI from the study facility
- Enrolment
- 61 participants (actual)
- Lead sponsor
- NuTech Medical, IncIndustry (pharma, biotech, devices)
- Study start
- Mar 2015
- Primary completion
- 1 Dec 2016 (actual)
- Study completion
- 15 Dec 2016 (actual)
- First posted
- 6 Mar 2015 (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 study is intended to demonstrate that the NuCel® allograft is effective and safe in promoting bone growth and fusion rate when used in cervical fusion in patients with one, two or three-level diseases of the cervical spine.
Detailed description
The study is intended to demonstrate that the NuCel® allograft is effective and safe in promoting bone growth and fusion rate when used in cervical fusion in patients with one, two or three-level diseases of the cervical spine. Sixty subjects will participate in the study at a single clinical site. Participants will be at least 21 years of age. All subjects will have been established with cervical spine disease at one, two or three levels of the cervical spine that requires cervical interbody fusion per the opinion of the treating surgeon. The primary objective is to demonstrate that NuCel® is comparable to autograft bone graft in producing a successful, contiguous fusion at 6 months ±4 weeks post-operative when used in cervical fusion surgery. Success based on findings of cervical CT scan and plain radiographs. Additionally, Visual Analog Scale (VAS), Neck Disability Index (NDI) and patient satisfaction will be used as secondary outcome measures.
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 Allograft Bone | Other | Other: NuCel with Allograft BoneNuCel will be used with allograft bone for the surgical treatment of one, two or three level degenerative disease of the cervical spine. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Be at least 21 years of age
- Have clinical and radiological evidence of degenerative disc disease, spondylosis, spinal stenosis, or spondylolisthesis at either one, two or three levels of cervical spine.
- In the opinion of the treating surgeon, must already be a qualified candidate for cervical fusion surgery.
- Be likely to return for regular follow-ups until the end of the study period.
- Be willing and able to provide Informed Consent for study participation.
Key exclusion criteria (9 listed)
- Neck pain due to acute trauma.
- Clinical, laboratory and/or radiological evidence of neck pain secondary to acute or chronic infection, malignancy, other space occupying lesions and metabolic bone demineralization diseases (e.g. osteomalacia, gout, Paget's disease etc.).
- Any terminal or autoimmune disease including but not limited to HIV infection, or rheumatoid arthritis.
- Any other concurrent medical disease or treatment that might significantly impair normal healing process as evaluated by the PI.
- Recent history (within past 6 months) of any chemical or alcohol dependence requiring treatment.
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 Allograft BoneNuCel is a minimally manipulated allograft product derived from amniotic membrane along with cells from amniotic fluid. Allograft bone is bone that comes another patient. NuCel and Allograft bone will be combined for this treatment. | Other | NuCel with Allograft Bone |
Primary outcome
Interbody Fusion measured using CT scans and standard radiographs
Time frame: 6 months
Interbody fusion will be measured using CT scans and standard radiographs
3 secondary outcomes
Change from baseline pain using Visual Analogue Scale (VAS)
Time frame: 6 weeks, 3 months, 6 months, 1 year
Change from baseline Neck Disability Index (NDI)
Time frame: 6 weeks, 3 months, 6 months, 1 year
Patient Satisfaction Survey
Time frame: 1 year
Results and safety
The study was stopped early (reason given: Departure of PI from the study facility). Results are not available in the source record.
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.
Franklin Lin, M.D. principal investigator
Wellstar Hospital
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 Allograft Bone in people with Spondylosis and Spinal Stenosis, 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 5 inclusion and 9 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 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 was stopped early (reason given: Departure of PI from the study facility). Results are not available in the source record.
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?
Interbody Fusion measured using CT scans and standard radiographs (time frame: 6 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.