Contacts

Stuart Pratt

CONTACT

901-238-5834 spratt@vivex.com

Nicolette Vega

CONTACT

650-888-1242 nicolette.vega@moxieclinical.com

Sponsors

Lead Sponsor

VIVEX Biologics, Inc.

Age

22 - 85 years

Sex

ALL

Healthy Volunteers

No

Inclusion Criteria

•1. Age 22 to 85 years old
•2. Diagnosis of early to moderate DDD, Modified Pfirrmann Grade 3-7
•3. Chronic axial midline low-back pain 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
•4. Positive hip flexion test as confirmed with the Neurologic Exam indicating positive provocation with sustained hip flexion at the time of screening
•5. Demonstrated intolerance to sitting for more than 30 minutes at a time based on self-report or assessed by a qualified healthcare professional at the screening visit
•6. Low-back pain severity score of ≥ 40 to ≤ 90 mm on the VAS at the time of Screening
•7. ODI score of ≥ 40 to ≤ 80 at the time of Screening

Exclusion Criteria

•1. Contraindication to MRI for any reason
•2. Contraindications to the proposed sedation/anesthetic protocol
•3. Symptomatic involvement of more than two lumbar discs
•4. Fracture of the spine, previous lumbar spine surgery or previous treatment of the target disc(s)
•5. Grade 2 or higher spondylolisthesis at the target disc, lumbar spondylitis or other undifferentiated spondyloarthropathy, or Type III Modic changes around the target disc
•6. Clinical suspicion of a full thickness annular tear at the target disc or other abnormal disc morphology
•7. Clinical suspicion of facet pain as primary pain generator
•8. 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
•9. Women of childbearing potential (WOCBP) who are not using a reliable form of contraception (as determined by the Investigator)

Related studies

RECRUITINGNA

Comparison of Clinical Outcomes, Complications Rate and Treatment Costs of Mini-TLIF and MIDLIF in the Treatment of Discogenic Low Back Pain

NCT07127380 · Lower Back Pain Chronic, Lumbar Degenerative Disease, and more

RECRUITINGPhase 3

A Study to Evaluate the Effectiveness of IDCT (Intradiscal Cell Therapy) in Subjects With One Level, Symptomatic Mild to Moderate Lumbar Degenerative Disc Disease

NCT07254806 · Degenerative Disc Disease

RECRUITINGNA

Comparaison of Interbody Bone Fusion Between Two Osteoinductive Bioactive Bone Substitutes After Anterior Lumbar Interbody Arthrodesis in Degenerative Lumbar Disc Surgery in Adults

NCT07044206 · Disc Degeneration

RECRUITINGNA

"Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nulcectomy" (LOPAIN2)

NCT05508360 · Degenerative Disc Disease, Chronic Low-back Pain

RECRUITINGNA

MagnetOs Flex Matrix Compared to Trinity Elite Mixed With Local Autograft in Patients Undergoing up to Four-level Instrumented Posterolateral Fusion

NCT05037968 · Degenerative Disc Disease, Spine Fusion, and more

View all related studies →

ASCEND: A Clinical Trial to Evaluate the Safety and Effectiveness of VIA Disc NP, a Supplement for Degenerated Intervertebral Discs

What this study is about

Clareo turns complex medical information into clear understanding you can use.

Contacts

Sponsors

Related studies

Comparison of Clinical Outcomes, Complications Rate and Treatment Costs of Mini-TLIF and MIDLIF in the Treatment of Discogenic Low Back Pain

A Study to Evaluate the Effectiveness of IDCT (Intradiscal Cell Therapy) in Subjects With One Level, Symptomatic Mild to Moderate Lumbar Degenerative Disc Disease

Comparaison of Interbody Bone Fusion Between Two Osteoinductive Bioactive Bone Substitutes After Anterior Lumbar Interbody Arthrodesis in Degenerative Lumbar Disc Surgery in Adults

"Lumbar Operatively Inserted PerQdisc Artificial Implant Following Nulcectomy" (LOPAIN2)

MagnetOs Flex Matrix Compared to Trinity Elite Mixed With Local Autograft in Patients Undergoing up to Four-level Instrumented Posterolateral Fusion

Trial snapshot

Condition

Locations shown

For caregivers