Viable Allograft Supplemented Disc Regeneration in the Treatment of Patients With Low Back Pain

Status unconfirmed · Not applicable · Has a placebo group

Conditions studied: Degenerative Disc Disease

In brief

The objective of this study is to evaluate the safety and efficacy of viable allograft transplantation for the treatment of patients with symptomatic disc degeneration and tissue loss. All subjects randomized to Active Allograft will undergo injection of a viable allograft into the nucleus pulposus of the degenerated disc. All subjects randomized to Placebo will undergo injection with saline into the nucleus pulposus of the degenerated disc. All subjects randomized to Conservative Care will continue standard of care, with the opportunity to crossover at 3 months into the Active Allograft arm.

Key facts

Study ID

NCT03709901

Run by

VIVEX Biologics, Inc.

People needed

218

Starts

2017-08-22

Expected to finish

2022-01-31

Last updated by the study team

2021-07-07

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Able to provide an English written Informed Consent
• Age 18 to 60 years inclusive
• Male or female
• Body mass index <35
• Pfirrmann Grade [3-6]
• Radiographic confirmation by MRI/X-ray of:
• translational instability defined as ≤5 mm, or
• angular instability defined as ≤5°
• Back pain (with or without radicular leg pain) measured by:
• ODI of at least 40%, and
• VASPI of at least 40mm
• Pathologic level between L1 and S1
• 1 or 2 vertebral level involvement that has been evaluated for at least 6 months and treated with conservative care
• Symptomatic back pain attributable to intervertebral disc for a minimum of 6 months
• No previous surgical treatment at the disc level(s) being considered
• Psychosocially, mentally and physically able to fully comply with this protocol, and follow-up schedule
• Ability to undergo allograft transplantation
• Life expectancy >2 years
• No contraindications to MRI
• No history of malignancy (basal cell carcinoma) or chronic infectious disease (e.g. HIV, Hepatitis)
• Agree to use appropriate contraception; not planning on becoming pregnant for 24 months after treatment
• Patient disc for transplant confirmed by inter-discal pressure measurement, or disc-imaging study.
• No signs or symptoms of infection
• No chronic use (>7 consecutive days) of anticoagulants (such as aspirin) or NSAIDs prior to treatment

You may not qualify if…

• Seropositive or seronegative spondyloarthropathy
• Type III Modic changes
• Prior surgeries of segments between L1 and S1
• Chemonucleolysis or percutaneous laserectomy of the affected disc prior to the study
• Chronic facet syndrome
• Stenosis of the spinal canal that is moderate to severe or more in degree
• Spondylodiscitis
• Spondylolisthesis (lysis and degenerative)
• Severe motor deficit or cauda equina disorder based on investigator determination
• Congenital abnormalities of the spinal nerves
• Pelvic and inguinal angiopathy
• Neurogenic inguinal syndrome
• Syringomyelia
• Diastematomyelia
• Traumatic neurological disorders
• Diseases of the kidney (nephritis, pyelonephritis)
• Other severe diseases of any other major body system as judged by the investigator
• Regular intake of systemic steroids
• Malignant diseases of any solid organ or any hematologic malignancy during the previous 5 years
• Patients who have participated in a clinical trial within the last month prior to inclusion
• Moderate to severe or greater lumbar stenosis of both transplantation endplates and adjacent levels

Where it is running

• Source Health — Santa Monica, California, United States
• IPM Medical Group — Walnut Creek, California, United States
• Laser Spine Institute — Tampa, Florida, United States
• Athens Orthopedic Clinic — Athens, Georgia, United States
• Neurological Institute of Savannah — Savannah, Georgia, United States
• OrthoIndy — Indianapolis, Indiana, United States
• Michigan Spine Clinic — Brownstown, Michigan, United States
• Ainsworth Institute of Pain Management — New York, New York, United States
• Clinical Investigations, LLC — Edmond, Oklahoma, United States
• Invictus Healthcare — Tulsa, Oklahoma, United States
• Texas Back Institute — Plano, Texas, United States
• Virginia iSpine Physicians — Richmond, Virginia, United States
• Gershon Pain Specialists — Virginia Beach, Virginia, United States

Full record on ClinicalTrials.gov

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