FLO for Discogenic Pain

Study Overview
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Brief Summary
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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.

Official Title
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FLO Injection for Discogenic Pain

Conditions
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Discogenic Back Pain

Intervention / Treatment
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* Other: amniotic and umbilical cord matrix


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AMUC Dosage 1<br>25mg amniotic and umbilical cord matrix | Other: amniotic and umbilical cord matrix<br>* 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.<br>|
| Experimental: AMUC Dosage 2<br>50mg amniotic and umbilical cord matrix | Other: amniotic and umbilical cord matrix<br>* 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.<br>|
| Experimental: AMUC Dosage 3<br>100mg amniotic and umbilical cord matrix | Other: amniotic and umbilical cord matrix<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in patient back pain determined by visual analog scale | 0 to 100mm, 100mm worst pain | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in quality of life determined by SF-36 | Short FormHealth Survey to evaluate quality of life across eight scales | 3 and 6 months | 
| Change in patient back pain determined by visual analog scale | 0 to 100mm, 100mm worst pain | 6 months | 
| Change in Oswestry Disability Index | 0 to 50, higher the percentile, the worse the perceived lower back pain | 3 and 6 months |