FLO for Discogenic Pain

Not Applicable

Terminated

• Conditions: Discogenic Back Pain
• Interventions: Other: amniotic and umbilical cord matrix

• Registration Number: NCT03644251
• Lead Sponsor: Tissue Tech Inc.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-08-13
• Study First Submitted: 2018-08-20
• Study First Submitted QC: 2018-08-21
• Study First Posted: 2018-08-23
• Status Verified: 2019-03
• Primary Completion: 2019-03-04
• Study Completion: 2019-03-04
• Last Update Submitted: 2019-03-13
• Last Update Posted: 2019-03-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 3

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
AMUC Dosage 1	amniotic and umbilical cord matrix	25mg amniotic and umbilical cord matrix
AMUC Dosage 2	amniotic and umbilical cord matrix	50mg amniotic and umbilical cord matrix
AMUC Dosage 3	amniotic and umbilical cord matrix	100mg amniotic and umbilical cord matrix

Primary Outcome Measures

Name	Time	Method
Change in patient back pain determined by visual analog scale	3 months	0 to 100mm, 100mm worst pain

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Laser Spine Institute; 🇺🇸 Tampa, Florida, United States