A Prospective Study of NuCel® in Cervical Spine Fusion

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.

Study Overview

• Status: Terminated
• Conditions: Intervertebral Disc Degeneration; Spinal Stenosis; Spondylosis; Spondylolisthesis; Intervertebral Disc Disease
• Intervention / Treatment: Other: NuCel with Allograft Bone

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 Type: Interventional
• Enrollment (Actual): 61
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Marietta, Georgia, United States, 30060
      • Wellstar Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Be at least 21 years of age
2. Have clinical and radiological evidence of degenerative disc disease, spondylosis, spinal stenosis, or spondylolisthesis at either one, two or three levels of cervical spine.
3. In the opinion of the treating surgeon, must already be a qualified candidate for cervical fusion surgery.
4. Be likely to return for regular follow-ups until the end of the study period.
5. Be willing and able to provide Informed Consent for study participation.

Exclusion Criteria:

1. Neck pain due to acute trauma.
2. 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.).
3. Any terminal or autoimmune disease including but not limited to HIV infection, or rheumatoid arthritis.
4. Any other concurrent medical disease or treatment that might significantly impair normal healing process as evaluated by the PI.
5. Recent history (within past 6 months) of any chemical or alcohol dependence requiring treatment.
6. Currently a prisoner.
7. Currently experiencing a major mental illness (psychosis, schizophrenia, major affective disorder) which may indicate that the symptoms are psychological rather than of physical origin.
8. Pregnancy at the time of enrollment.
9. 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: NuCel with Allograft Bone; NuCel will be used with allograft bone for the surgical treatment of one, two or three level degenerative disease of the cervical spine.	Other: NuCel with Allograft Bone; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Interbody Fusion measured using CT scans and standard radiographs	Interbody fusion will be measured using CT scans and standard radiographs	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Change from baseline pain using Visual Analogue Scale (VAS)	6 weeks, 3 months, 6 months, 1 year
Change from baseline Neck Disability Index (NDI)	6 weeks, 3 months, 6 months, 1 year
Patient Satisfaction Survey	1 year

Collaborators and Investigators

• Sponsor: NuTech Medical, Inc
• Investigators: Principal Investigator: Franklin Lin, M.D., Wellstar Hospital

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (Actual): December 1, 2016
• Study Completion (Actual): December 15, 2016

Study Registration Dates

• First Submitted: March 2, 2015
• First Submitted That Met QC Criteria: March 5, 2015
• First Posted (Estimate): March 6, 2015

Study Record Updates

• Last Update Posted (Actual): January 18, 2020
• Last Update Submitted That Met QC Criteria: January 14, 2020
• Last Verified: January 1, 2020

More Information

Terms related to this study

• Keywords: Prospective; Cervical Fusion; NuCel; Amniotic Allograft
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spondylolysis; Intervertebral Disc Degeneration; Spinal Stenosis; Spondylosis; Spondylolisthesis
• Other Study ID Numbers: RD2015-01-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO