Brief Summary
VIA Disc NP is a non-surgical intervention intended to supplement nucleus pulposus tissue in degenerated intervertebral discs.
This is a randomized, sham-controlled, multi-center, double-blind clinical trial with an open label roll-in period of one participant per site in which participants with lumbar discogenic pain associated with DDD will receive one VIA Disc NP treatment to each affected level (up to 2 levels). Participants enrolled after the roll-in stage will be randomized on a 2:1 basis to receive either a single VIA Disc NP intradiscal injection at 1 or 2 levels or the sham procedure at 1 or 2 levels. At 12 months, participants in the sham arm with continued symptoms may cross-over, receive VIA Disc NP, and will restart the study visit schedule, completing an additional 12 months of follow-up post-cross-over.
This is a randomized, sham-controlled, multi-center, double-blind clinical trial with an open label roll-in period of one participant per site in which participants with lumbar discogenic pain associated with DDD will receive one VIA Disc NP treatment to each affected level (up to 2 levels). Participants enrolled after the roll-in stage will be randomized on a 2:1 basis to receive either a single VIA Disc NP intradiscal injection at 1 or 2 levels or the sham procedure at 1 or 2 levels. At 12 months, participants in the sham arm with continued symptoms may cross-over, receive VIA Disc NP, and will restart the study visit schedule, completing an additional 12 months of follow-up post-cross-over.
Brief Title
Clinical Trial Evaluating the Safety and Efficacy of Nucleus Pulposus Allograft in Participants With Degenerative Disc Disease
Central Contacts
Central Contact Role
Contact
Central Contact Phone
714-366-6457
Central Contact Email
lzaccari@vivex.com
Completion Date
Completion Date Type
Estimated
Conditions
Degenerative Disc Disease
Disc Degeneration
Lumbar Discogenic Pain
Eligibility Criteria
Inclusion Criteria:
* Age 22 to 85 years old
* Diagnosis of moderate to severe DDD on MRI, Modified Pfirrmann Grade 3-7
* Chronic axial midline low-back pain in the absence of lower extremity motor/sensory/reflex changes with or without referred non-radicular leg pain for at least 6 months prior to screening; unresponsive to at least 3 months of conservative care
* Low-back pain severity score of ≥ 40 to ≤ 90 mm on the VAS
* ODI score of ≥ 40 to ≤ 80
* Positive sustained hip flexion test
* Demonstrated intolerance to sitting
* Able to give voluntary, written informed consent to participate and have signed an Informed Consent Form specific to this study
* Willing and able to comply with all study procedures and availability for the duration of the study with a life expectancy of \> 2 years
Exclusion Criteria:
* Contraindications to the proposed sedation/anesthetic protocol
* Involvement of more than two lumbar discs as evidenced by 3 or more discs with Modified Pfirrmann grade of 3 or greater
* Disc height of less than 4mm for any disc between L1-S1
* Symptomatic vertebral compression fracture
* Previous surgical treatment of the lumbar spine
* History of sacroiliac (SI) joint fusion within the past six months
* Received lumbar epidural or intradiscal steroid injection, lumbar facet joint steroid injection, lumbar radiofrequency ablation, provocative or anesthetic discography, SI joint pain injection, injection of methylene blue, dextrose, glucosamine, and chondroitin sulfate, or biacuplasty within 3 months of the Day 0 procedure
* Received intraosseous radiofrequency nerve ablation procedure at the same or adjacent level (e.g., Basivertebral nerve ablation or sinuvertebral nerve ablations)
* Received prior intradiscal stem cell/progenitor cell therapy or other biological intervention (e.g., MSC, PRP) at the target level within 12 months of the Day 0 procedure
* Evidence of dynamic instability on lumbar flexion-extension radiographs (\>3 mm)
* Grade 2 or higher spondylolisthesis at the target level, lumbar spondylitis or other undifferentiated spondyloarthropathy, or Type III Modic changes adjacent to the target disc
* Radiographic evidence of a full thickness annular tear at the target disc or other abnormal disc morphology
* Clinical suspicion of facet pain as primary pain generator
* A systemic condition or disease not stabilized or judged by the Investigator to be incompatible with participation in the study (e.g. current systemic infection, uncontrolled autoimmune disease, uncontrolled immunodeficiency disease, recent history of myocardial infarction, uncontrolled diabetes (\>7.0% HbA1C), etc.)
* Received VIA Disc NP previously.
* Deemed unsuitable for clinical study participation by the Investigator
* 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 and 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
* Opioid use of more than 90 MME/day
* Currently receiving treatment with radiation, chemotherapy, immunosuppression, or chronic steroid therapy (prednisone, or its equivalent, use of up to 5 mg/qd, or inhalation steroids for asthma is allowed)
* Metal or ceramic implants in the lumbar spine region
* Contraindications to MRI, including non-MRI compatible devices and active implantable devices such as spinal cord stimulators, intrathecal pumps, etc.
* Involved in ongoing or closed (within 6 months of screening visit) litigation related to their back pain condition
* Any mental instability, unstable bipolar disorders, unmanaged 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
* Diagnosis of any traumatic neurological disorders that may impact the study as per the judgement of the Investigator
* Women who are pregnant or breastfeeding at the time of enrollment and/or plan to become pregnant during the study; pregnancy is confirmed by:
* a positive pregnancy test during the screening visit
* self-reported pregnancy
* Women of childbearing potential (WOCBP) who are not using a reliable form of contraception (as determined by the Investigator)
* Received any experimental drug or device to treat the same condition used within 6 months prior to the screening visit or during the course of the clinical trial
* Other persistent pain/nerve issues including, for example, radiculopathy, leg pain, cauda equine syndrome, etc.
* Age 22 to 85 years old
* Diagnosis of moderate to severe DDD on MRI, Modified Pfirrmann Grade 3-7
* Chronic axial midline low-back pain in the absence of lower extremity motor/sensory/reflex changes with or without referred non-radicular leg pain for at least 6 months prior to screening; unresponsive to at least 3 months of conservative care
* Low-back pain severity score of ≥ 40 to ≤ 90 mm on the VAS
* ODI score of ≥ 40 to ≤ 80
* Positive sustained hip flexion test
* Demonstrated intolerance to sitting
* Able to give voluntary, written informed consent to participate and have signed an Informed Consent Form specific to this study
* Willing and able to comply with all study procedures and availability for the duration of the study with a life expectancy of \> 2 years
Exclusion Criteria:
* Contraindications to the proposed sedation/anesthetic protocol
* Involvement of more than two lumbar discs as evidenced by 3 or more discs with Modified Pfirrmann grade of 3 or greater
* Disc height of less than 4mm for any disc between L1-S1
* Symptomatic vertebral compression fracture
* Previous surgical treatment of the lumbar spine
* History of sacroiliac (SI) joint fusion within the past six months
* Received lumbar epidural or intradiscal steroid injection, lumbar facet joint steroid injection, lumbar radiofrequency ablation, provocative or anesthetic discography, SI joint pain injection, injection of methylene blue, dextrose, glucosamine, and chondroitin sulfate, or biacuplasty within 3 months of the Day 0 procedure
* Received intraosseous radiofrequency nerve ablation procedure at the same or adjacent level (e.g., Basivertebral nerve ablation or sinuvertebral nerve ablations)
* Received prior intradiscal stem cell/progenitor cell therapy or other biological intervention (e.g., MSC, PRP) at the target level within 12 months of the Day 0 procedure
* Evidence of dynamic instability on lumbar flexion-extension radiographs (\>3 mm)
* Grade 2 or higher spondylolisthesis at the target level, lumbar spondylitis or other undifferentiated spondyloarthropathy, or Type III Modic changes adjacent to the target disc
* Radiographic evidence of a full thickness annular tear at the target disc or other abnormal disc morphology
* Clinical suspicion of facet pain as primary pain generator
* A systemic condition or disease not stabilized or judged by the Investigator to be incompatible with participation in the study (e.g. current systemic infection, uncontrolled autoimmune disease, uncontrolled immunodeficiency disease, recent history of myocardial infarction, uncontrolled diabetes (\>7.0% HbA1C), etc.)
* Received VIA Disc NP previously.
* Deemed unsuitable for clinical study participation by the Investigator
* 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 and 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
* Opioid use of more than 90 MME/day
* Currently receiving treatment with radiation, chemotherapy, immunosuppression, or chronic steroid therapy (prednisone, or its equivalent, use of up to 5 mg/qd, or inhalation steroids for asthma is allowed)
* Metal or ceramic implants in the lumbar spine region
* Contraindications to MRI, including non-MRI compatible devices and active implantable devices such as spinal cord stimulators, intrathecal pumps, etc.
* Involved in ongoing or closed (within 6 months of screening visit) litigation related to their back pain condition
* Any mental instability, unstable bipolar disorders, unmanaged 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
* Diagnosis of any traumatic neurological disorders that may impact the study as per the judgement of the Investigator
* Women who are pregnant or breastfeeding at the time of enrollment and/or plan to become pregnant during the study; pregnancy is confirmed by:
* a positive pregnancy test during the screening visit
* self-reported pregnancy
* Women of childbearing potential (WOCBP) who are not using a reliable form of contraception (as determined by the Investigator)
* Received any experimental drug or device to treat the same condition used within 6 months prior to the screening visit or during the course of the clinical trial
* Other persistent pain/nerve issues including, for example, radiculopathy, leg pain, cauda equine syndrome, etc.
Inclusion Criteria
Inclusion Criteria:
* Age 22 to 85 years old
* Diagnosis of moderate to severe DDD on MRI, Modified Pfirrmann Grade 3-7
* Chronic axial midline low-back pain in the absence of lower extremity motor/sensory/reflex changes with or without referred non-radicular leg pain for at least 6 months prior to screening; unresponsive to at least 3 months of conservative care
* Low-back pain severity score of ≥ 40 to ≤ 90 mm on the VAS
* ODI score of ≥ 40 to ≤ 80
* Positive sustained hip flexion test
* Demonstrated intolerance to sitting
* Able to give voluntary, written informed consent to participate and have signed an Informed Consent Form specific to this study
* Willing and able to comply with all study procedures and availability for the duration of the study with a life expectancy of \> 2 years
* Age 22 to 85 years old
* Diagnosis of moderate to severe DDD on MRI, Modified Pfirrmann Grade 3-7
* Chronic axial midline low-back pain in the absence of lower extremity motor/sensory/reflex changes with or without referred non-radicular leg pain for at least 6 months prior to screening; unresponsive to at least 3 months of conservative care
* Low-back pain severity score of ≥ 40 to ≤ 90 mm on the VAS
* ODI score of ≥ 40 to ≤ 80
* Positive sustained hip flexion test
* Demonstrated intolerance to sitting
* Able to give voluntary, written informed consent to participate and have signed an Informed Consent Form specific to this study
* Willing and able to comply with all study procedures and availability for the duration of the study with a life expectancy of \> 2 years
Gender
All
Gender Based
false
Keywords
Degenerative Disc Disease
Lumbar Discogenic Pain
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
85 Years
Minimum Age
22 Years
NCT Id
NCT06778447
Org Class
Industry
Org Full Name
VIVEX Biologics, Inc.
Org Study Id
VIA-2024-002
Overall Status
Recruiting
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
Randomized, Sham-Controlled, Multi-Center, Double-Blind Clinical Trial Evaluating the Safety and Efficacy of Nucleus Pulposus Allograft to Supplement Nucleus Pulposus Tissue in Participants With Lumbar Discogenic Pain Associated With Degenerative Disc Disease
Primary Outcomes
Outcome Description
The primary efficacy endpoint is the proportion of participants who achieve a minimal clinically important difference (MCID), defined as at least a 30% reduction in back pain VAS score from baseline to 12 months, in the VIA Disc NP group compared to that in the sham-control group.
Outcome Measure
Primary Effectiveness Endpoint - Proportion of participants achieving MCID in VAS score from baseline to 12 months.
Outcome Time Frame
Baseline to 12 Months
Outcome Description
The primary safety endpoint will be the proportion of participants that experience one or more treatment-related (Investigational Product (IP) or procedure), adverse events (AE) in the VIA Disc NP group compared to the sham-control group at 12 months.
Outcome Measure
Primary Safety Endpoint - Proportion of participants reporting treatment-related AEs at 12 months.
Outcome Time Frame
Baseline to 12 Months
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
85
Minimum Age Number (converted to Years and rounded down)
22
Investigators
Investigator Type
Principal Investigator
Investigator Name
Corey Hunter
Investigator Email
cohunter@montefiore.org
Investigator Sponsor Organization
External
Study Department
Rehabilitation Medicine
Study Division
Pain Medicine
Categories Mesh Debug
Orthopedics, Muscle & Bone --- BONE DISEASES
Child Development & Autism --- MUSCULOSKELETAL DISEASES
Orthopedics, Muscle & Bone --- MUSCULOSKELETAL DISEASES
MeSH Terms
INTERVERTEBRAL DISC DEGENERATION
SPINAL DISEASES
BONE DISEASES
MUSCULOSKELETAL DISEASES
SALICYLHYDROXAMIC ACID