Study Stopped
Study Site Ceased all Business Operations
FLO for Discogenic Pain
FLO Injection for Discogenic Pain
1 other identifier
interventional
3
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Aug 2018
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 13, 2018
CompletedFirst Submitted
Initial submission to the registry
August 20, 2018
CompletedFirst Posted
Study publicly available on registry
August 23, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 4, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 4, 2019
CompletedMarch 15, 2019
March 1, 2019
7 months
August 20, 2018
March 13, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Change in patient back pain determined by visual analog scale
0 to 100mm, 100mm worst pain
3 months
Secondary Outcomes (3)
Change in quality of life determined by SF-36
3 and 6 months
Change in patient back pain determined by visual analog scale
6 months
Change in Oswestry Disability Index
3 and 6 months
Study Arms (3)
AMUC Dosage 1
EXPERIMENTAL25mg amniotic and umbilical cord matrix
AMUC Dosage 2
EXPERIMENTAL50mg amniotic and umbilical cord matrix
AMUC Dosage 3
EXPERIMENTAL100mg amniotic and umbilical cord matrix
Interventions
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 Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Laser Spine Institute
Tampa, Florida, 33607, United States
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 20, 2018
First Posted
August 23, 2018
Study Start
August 13, 2018
Primary Completion
March 4, 2019
Study Completion
March 4, 2019
Last Updated
March 15, 2019
Record last verified: 2019-03