A Pilot Study Evaluating the Safety and Clinical Effectiveness of Nucleus Pulposus Allograft for Supplementation of Nucleus Pulposus Tissue in Older Patients With Symptomatic Degenerated Discs

Status: Active_not_recruiting
Location: See all (5) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

VIA Disc NP is a non-surgical intervention intended to supplement the nucleus pulposus tissue in degenerated intervertebral discs.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 65
Healthy Volunteers: f
View:

• Age 65 years or older

• Body mass index (BMI) ≤ 35

• Documented diagnosis of moderate radiographic degeneration of up to 3 intervertebral discs from L1 to S1, with a suspected associated discogenic chronic low back pain

• Chronic LBP for ≥ 6 months

• Discogenic low back pain diagnosis based on:

‣ History including low back pain aggravated with coughing, sneezing, and increase of abdominal pressure

⁃ Physical exam including pain with flexion (sitting or standing), and/or sitting intolerance

• Failed conservative care over the past 6 months of at least 2 conservative treatments including:

‣ oral pain medication (analgesics, steroids and/or non-steroidal anti-inflammatory drugs \[NSAIDs\]),

⁃ structured physical therapy or exercise program prescribed by physical therapist, chiropractor provider or physician specifically for the treatment of low back pain

⁃ epidural steroid injections and/or facet injections/selective nerve blocks

• An MRI demonstrating:

‣ 1 to 3 vertebral level involvement L1-S1

⁃ Modified Pfirrmann Grade 3-7

⁃ No Modic changes or if changes ≤ 2

• Oswestry Disability Index (ODI) score at time of evaluation of ≥ 21 and ≤ 80 points

• Low back pain of Baseline Numeric Rating Scale (NRS) score of ≥ 5 on the 11-point scale

• No signs or symptoms of current infection

• Be able to give voluntary, written informed consent to participate and have signed an Informed Consent Form specific to this study

• Be willing and able to comply with all study procedures and availability for the duration of the study with a life expectancy of \> 2 years

Locations
United States
Florida
Florida Spine & Pain Specialists
Tampa
Georgia
Southern Pain and Spine Associates
Newnan
Louisiana
Paradigm Spine Care & Interventional Pain
Slidell
North Carolina
Center for Clinical Research
Winston-salem
Texas
Precision Spine Care
Tyler
Time Frame
Start Date: 2022-10-17
Completion Date: 2024-12-31
Participants
Target number of participants: 21
Treatments
Other: VIA Disc NP
HCT/P: VIA Disc Nucleus Pulposus Allograft
Related Therapeutic Areas
Sponsors
Leads: VIVEX Biologics, Inc.

This content was sourced from clinicaltrials.gov