FLO for Discogenic Pain

BioTissue Holdings, Inc3 enrolled

Overview

Discogenic pain is pain originating from a damaged vertebral disc and be caused by inflammation, dehydration of the nucleus pulposus, decreased disc height, annular tears and impaired mechanical function of the disc.Non-operative treatment may include traction, steroid therapy, methylene blue injection and ablative therapy. However, there are few high quality studies evaluating these treatments for reducing discogenic low back pain and most clinical trials failed to detect significant differences between treatments and placebo therapies. Hence, there remains an unmet clinical need.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Discogenic Back Pain

Interventions

amniotic and umbilical cord matrixOTHER

Cryopreserved human amniotic and umbilical cord product derived from donated human placental tissue following healthy, live, caesarian section, full-term births after determination of donor eligibility and placenta suitability.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * subject (male or female) is at least 18 to 70 years of age * diagnosed with single level discogenic back pain confirmed by MRI and positive discography per Spine Interventional Society Guidelines * Diagnosis of disc degeneration with Pfirrmann score of 1-3 * Subject has failed at least six months of conservative care * Subject is symptomatic with axial lower back pain greater than lower limb pain at the intensity of \>6/10 concordant or partially concordant * The subject is able to comply with all post-operative standard of care and follow instructions. Exclusion Criteria: * Subjects has significant disc protrusion, severe lumbar spinal stenosis, spine tumor, severe disc degeneration, or Sacroiliac (SI) joint syndrome * Subject had previous surgery at the disc level * Patient has previously received injection of FLO within 3 months of screening * The subject is unable to comply with follow-up or not appropriate for inclusion based on investigator decision

Locations (1)

Laser Spine Institute

Tampa, Florida, United States

Outcomes

Primary Outcomes

Change in patient back pain determined by visual analog scale

0 to 100mm, 100mm worst pain

Time frame: 3 months

Secondary Outcomes

Change in quality of life determined by SF-36

Short FormHealth Survey to evaluate quality of life across eight scales

Time frame: 3 and 6 months

Change in patient back pain determined by visual analog scale

0 to 100mm, 100mm worst pain

Time frame: 6 months

Change in Oswestry Disability Index

0 to 50, higher the percentile, the worse the perceived lower back pain

Time frame: 3 and 6 months

Data from ClinicalTrials.gov

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