Degenerative Disc DiseaseNCT05412277
VIA Disc Nucleus Pulposus Older Patients Pilot
A study testing VIA Disc Nucleus Pulposus Allograft in people with Degenerative Disc Disease and Low Back Pain, run by VIVEX Biologics, Inc. at 5 sites in United States.
Trial summary
VIA Disc NP is a non-surgical intervention intended to supplement the nucleus pulposus tissue in degenerated intervertebral discs. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Degenerative Disc Disease, Low Back Pain, Disc Degeneration
- What is being tested?
- VIA Disc Nucleus Pulposus Allograft
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 5 sitesUnited States
- Study dates
- 17 Oct 2022to 31 Dec 2024
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- Contraindications to the proposed sedation/anesthetic protocol;
- Radicular pain greater than back pain by history within the past 8 weeks. Radicular pain is defined as nerve pain following a dermatomal distribution and that correlates with nerve compression on imaging. Somatic referred pain is allowed;
- Known allergies to Gentamicin or Vancomycin
- Any of the following conditions at the index level:
- Contained disc protrusion >5 mm or disc extrusion, or spondylolisthesis >5 mm (lysis and degenerative);
- Seronegative spondyloarthropathy;
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- Symptomatic spinal stenosis (moderate to severe in degree);
- Chronic facet syndrome;
- Spondylodiscitis;
- Bilateral spondylolysis;
- Current or history of osteoporotic or tumor-related vertebral body compression fracture;
- Previous lumbar spine fusion surgery or disc arthroplasty;
- History of sacroiliac (SI) joint pain/injections during the past 1 months or SI joint fusion within the past six months;
- Received chemonucleolysis or percutaneous treatment of the affected disc prior to the study;
- History of lumbar epidural steroid injections within 4 weeks prior to study treatment;
- Received any lumbar intradiscal treatment injection or procedure (e.g., injection of methylene blue, dextrose, glucosamine, and chondroitin sulfate, or biacuplasty) and any nerve ablation procedures at the same or adjacent level (e.g., Basivertebral nerve ablation, dorsal ramus or sinovertebral nerve ablations). Discography and anesthetic discography may be performed but must be done at least 2 weeks or more prior to the injection procedure;
- History of lumbar facet joint steroid injections within 4 weeks of procedure;
- History of radiofrequency ablation within 8 weeks of procedure;
- Been a recipient of prior stem cell/progenitor cell therapy or other biological intervention (e.g., PRP) to repair the target intervertebral disc;
- Severe motor deficit or cauda equina disorder based on investigator determination;
- Diagnosis of any traumatic neurological disorders;
- Severe diseases of any other major body system as judged by the investigator, including malignant diseases of any solid organ or any hematologic malignancy during the previous 5 years;
- Demonstrate 3 or more Waddell's signs of Inorganic Behavior;
- Any mental instability, bipolar disorders, post-traumatic stress disorder (PTSD) or uncontrolled anxiety/depression and/or require new or changed anti-depressants or anti-psychotic medications within 3 months of enrollment;
- Compensated injuries or ongoing litigation regarding back pain/injury, or financial or other incentives to remain impaired;
- Any medical condition that impairs follow-up (i.e., fibromyalgia, rheumatoid arthritis, chronic regional pain syndrome, reflex sympathetic dystrophy);
- Evidence of substance abuse (including marijuana); Note: subjects using prescribed extended-release narcotics (e.g., fentanyl patch, MS Contin, oxycontin) within the 3 months prior to screening; subjects on long-acting opioids may be given option to wean off opiates before enrollment. Subjects on short-acting opiates (e.g., hydrocodone, oxycodone, tramadol, etc.) may be included and utilization monitored after the treatment;
- Are currently receiving treatment with radiation, chemotherapy, immunosuppression, or chronic steroid therapy (prednisone, or its equivalent, use of up to 5 mg/qd is allowed, as well as inhalation steroids for asthma);
- Non-MRI compatible devices and active implantable devices, such as spinal cord stimulators, intrathecal pumps, etc.
- Bilateral spondylolysis at any level;
- Fracture of the spine, previous lumbar spine surgery or previous treatment of the target disc(s)
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Southern Pain and Spine Associates
Newnan, Georgia, 30263
Paradigm Spine Care & Interventional Pain
Slidell, Louisiana, 70458
Florida Spine & Pain Specialists
Tampa, Florida, 33614
Precision Spine Care
Tyler, Texas, 75701
Center for Clinical Research
Winston-Salem, North Carolina, 27103
About this study
Official title: 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
VIA Disc NP is a non-surgical intervention intended to supplement the nucleus pulposus tissue in degenerated intervertebral discs.
Read the detailed description
The study will include adult subjects, ages 65 years and older, with symptomatic lumbar intervertebral disc degeneration that is not adequately resolved by non-surgical standard care.
Each subject will receive one injection per each affected level (max of 3 levels) and be evaluated for efficacy and safety during the 6 month observation period. The study is expected to be completed within 18 months, inclusive of enrollment and follow-up for all subjects.
Subjects will be evaluated at baseline and followed through 6 months to establish safety and efficacy of the treatment. The expected duration of subject participation from screening/enrollment through final follow-up is 26 weeks
- Conditions
- Degenerative Disc Disease, Low Back Pain, Disc Degeneration
- Being tested
- VIA Disc Nucleus Pulposus Allograft
- Keywords
- low back pain, degenerative disc disease
- Medical subject headings
- Intervertebral Disc Degeneration, Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VIA Disc Nucleus Pulposus AllograftOther
A single dose, intradiscal injection of 100mg of VIA Disc NP mixed with 2ml sterile saline administered to the affected 1 to 3 levels, L1-S1.
| Study group | Role | What they receive |
|---|---|---|
| VIA Disc NP | Other | HCT/P: VIA Disc Nucleus Pulposus Allograft Receives: Other: VIA Disc Nucleus Pulposus Allograft |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient self-reporting of Functional Efficacy with no change in neurological status using the Oswestry Disability Index (ODI)
Evaluate the change from baseline in functional disability on the Oswestry Disability Index (ODI) measured from 0 (minimal disability) to 100 (maximal disability). The ODI is 10 categories of function to quantify disability due to low back pain.
Measured: baseline to 3 months
Review of all Adverse Events for Safety of treatment and product
Evaluate the incidence of related Adverse Events (AEs), Serious Adverse Events (SAEs), and Unanticipated Adverse Events from baseline through the final follow-up visit that are related to treatment and product
Measured: baseline to 6 months
Patient self-reporting of Pain
Changes in Numeric Rating Scale (NRS) scores. Eleven point pain scale used for patient self-reporting of back pain, which ranges from 0 (no pain) to 10 (the worst pain imaginable). Analysis at 3 months measuring subjects meeting lower back pain NRS improvement.
Measured: baseline and 3 months
Secondary outcomes (9)
Patient self-reporting of Function
Oswestry Disability Index (ODI) is measured 0 (minimal disability) to 100 (maximal disability). This index is comprised of ten categories of function to quantify disability due to low back pain. Functional responder analysis at 3 and 6 months measured as subjects meeting functional improvement of ≥ 10, 15 and 20 points in ODI scores.
Measured: 3-6 months
Patient self-reporting of Pain
Changes in Numeric Rating Scale (NRS) scores. Eleven point pain scale used for patient self-reporting of back pain, which ranges from 0 (no pain) to 10 (the worst pain imaginable). Analysis at 3 and 6 months measured as subjects meeting lower back pain NRS improvement of 50%.
Measured: 3-6 months
Patient self-reporting of Pain in low back
Changes in Numeric Rating Scale (NRS) scores. Eleven-point pain scale used for patient to self-report level of back pain, which ranges from 0 (no pain) to 10 (the worst pain imaginable). Analysis at 3 and 6 months measured as subjects meeting lower back pain NRS improvement of ≥30%.
Measured: 3-6 months
Oswestry Disability Index (ODI) score change
Change from baseline in ODI scores at 6 months. Ten category index comprising of function to quantify due to low back pain. ODI is measured 0 (minimal disability) to 100 (maximal disability).
Measured: baseline and 6 months
Numeric Rating Scale change
Changes from baseline in Numeric Rating Scale (NRS) score at 6 months. Eleven-point pain scale used for patient self-reporting of pain, which ranges from 0 (no pain) to 10 (the worst pain imaginable).
Measured: baseline, and 6 months
Neurological status change
Change from baseline in motor function (graded 0 - no movement to 4 - active movement against resistance), reflexes (0 - absence to 4 - abnormal/hyperactive) and sensory status (graded normal or abnormal) based on physician's physical exam at 1, 3, and 6 months.
Measured: baseline, 1, 3 and 6 months
Magnetic Resonance Imaging (MRI) review to determine disc health changes
Magnetic Resonance Imaging (MRI) taken at baseline compared to 6 months reviewing changes in treated disc levels (disc height, volume hydration of disc and Modified Pfirrman grade)
Measured: baseline - 6 months
Morphine Milligram Equivalents (MME) change
Changes from baseline in morphine milligram equivalents use at 3 and 6 months.
Measured: baseline, 1, 3 and 6 months
PROMIS-29 change
Change from baseline in pain intensity at 3 and 6 months. Questionnaire with 29 questions using a since 0-10 numeric rating item and sevel health domains (physical function, pain interference, fatigue depressive symptoms, anxiety, ability to participate in activities and sleep) utilizing four questions per domain.
Measured: baseline, 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2022
- Study start17 Oct 2022
- Primary completion30 Aug 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Not applicable
- Intervention model
- Single group
- Model description
- Up to 35 patients at up to 15 sites will receive treatment.
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- VIVEX Biologics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nomen Azeem, MD, Principal investigator, Florida Spine & Pain Specialists
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05412277
- Sponsor's protocol ID
- VIA-2022-001
- Status last verified
- Apr 2024
- First submitted
- 6 Jun 2022
- Last updated
- 29 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share IPD
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05412277
- Acronym / sponsor ID
- VIA-2022-001
- Conditions
- Degenerative Disc Disease, Low Back Pain, Disc Degeneration
- Keywords
- low back pain, degenerative disc disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 21 participants (actual)
- Lead sponsor
- VIVEX Biologics, Inc.Industry (pharma, biotech, devices)
- Study start
- 17 Oct 2022 (actual)
- Primary completion
- 30 Aug 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 9 Jun 2022 (actual)
- 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.
VIA Disc NP is a non-surgical intervention intended to supplement the nucleus pulposus tissue in degenerated intervertebral discs.
Detailed description
The study will include adult subjects, ages 65 years and older, with symptomatic lumbar intervertebral disc degeneration that is not adequately resolved by non-surgical standard care.
Each subject will receive one injection per each affected level (max of 3 levels) and be evaluated for efficacy and safety during the 6 month observation period. The study is expected to be completed within 18 months, inclusive of enrollment and follow-up for all subjects.
Subjects will be evaluated at baseline and followed through 6 months to establish safety and efficacy of the treatment. The expected duration of subject participation from screening/enrollment through final follow-up is 26 weeks
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Up to 35 patients at up to 15 sites will receive treatment.
| Arm | Type | Receives |
|---|---|---|
| VIA Disc NP | Other | Other: VIA Disc Nucleus Pulposus AllograftHCT/P: VIA Disc Nucleus Pulposus Allograft |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (20 listed)
- 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:
Key exclusion criteria (31 listed)
- Contraindications to the proposed sedation/anesthetic protocol;
- Radicular pain greater than back pain by history within the past 8 weeks. Radicular pain is defined as nerve pain following a dermatomal distribution and that correlates with nerve compression on imaging. Somatic referred pain is allowed;
- Known allergies to Gentamicin or Vancomycin
- Any of the following conditions at the index level:
- History of sacroiliac (SI) joint pain/injections during the past 1 months or SI joint fusion within the past six months;
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 |
|---|---|---|
| VIA Disc Nucleus Pulposus AllograftA single dose, intradiscal injection of 100mg of VIA Disc NP mixed with 2ml sterile saline administered to the affected 1 to 3 levels, L1-S1. | Other | VIA Disc NP |
Primary outcome
Patient self-reporting of Functional Efficacy with no change in neurological status using the Oswestry Disability Index (ODI)
Time frame: baseline to 3 months
Evaluate the change from baseline in functional disability on the Oswestry Disability Index (ODI) measured from 0 (minimal disability) to 100 (maximal disability). The ODI is 10 categories of function to quantify disability due to low back pain.
Review of all Adverse Events for Safety of treatment and product
Time frame: baseline to 6 months
Evaluate the incidence of related Adverse Events (AEs), Serious Adverse Events (SAEs), and Unanticipated Adverse Events from baseline through the final follow-up visit that are related to treatment and product
Patient self-reporting of Pain
Time frame: baseline and 3 months
Changes in Numeric Rating Scale (NRS) scores. Eleven point pain scale used for patient self-reporting of back pain, which ranges from 0 (no pain) to 10 (the worst pain imaginable). Analysis at 3 months measuring subjects meeting lower back pain NRS improvement.
9 secondary outcomes
Patient self-reporting of Function
Time frame: 3-6 months
Patient self-reporting of Pain
Time frame: 3-6 months
Patient self-reporting of Pain in low back
Time frame: 3-6 months
Oswestry Disability Index (ODI) score change
Time frame: baseline and 6 months
Numeric Rating Scale change
Time frame: baseline, and 6 months
Neurological status change
Time frame: baseline, 1, 3 and 6 months
Magnetic Resonance Imaging (MRI) review to determine disc health changes
Time frame: baseline - 6 months
Morphine Milligram Equivalents (MME) change
Time frame: baseline, 1, 3 and 6 months
PROMIS-29 change
Time frame: baseline, 3 and 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2024.
- Individual participant dataSharing planned: No. No plan to share IPD
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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.
Nomen Azeem, MD principal investigator
Florida Spine & Pain Specialists
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VIA Disc Nucleus Pulposus Allograft in people with Degenerative Disc Disease and Low Back Pain, run by VIVEX Biologics, Inc. at 5 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 20 inclusion and 31 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: status not confirmed, as of the sponsor's last update on 29 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
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?
Patient self-reporting of Functional Efficacy with no change in neurological status using the Oswestry Disability Index (ODI) (time frame: baseline to 3 months). The study lists 3 primary outcomes in all. 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 29 Apr 2024.