Back to resultsFLO for Discogenic Pain
Primary Purpose
Discogenic Back Pain
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
amniotic and umbilical cord matrix
Sponsored by
About this trial
This is an interventional treatment trial for Discogenic Back Pain
Eligibility Criteria
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
Sites / Locations
- Laser Spine Institute
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
AMUC Dosage 1
AMUC Dosage 2
AMUC Dosage 3
Arm Description
25mg amniotic and umbilical cord matrix
50mg amniotic and umbilical cord matrix
100mg amniotic and umbilical cord matrix
Outcomes
Primary Outcome Measures
Change in patient back pain determined by visual analog scale
0 to 100mm, 100mm worst pain
Secondary Outcome Measures
Change in quality of life determined by SF-36
Short FormHealth Survey to evaluate quality of life across eight scales
Change in patient back pain determined by visual analog scale
0 to 100mm, 100mm worst pain
Change in Oswestry Disability Index
0 to 50, higher the percentile, the worse the perceived lower back pain
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03644251
Brief Title
FLO for Discogenic Pain
Official Title
FLO Injection for Discogenic Pain
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Terminated
Why Stopped
Study Site Ceased all Business Operations
Study Start Date
August 13, 2018 (Actual)
Primary Completion Date
March 4, 2019 (Actual)
Study Completion Date
March 4, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tissue Tech Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Discogenic Back Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
AMUC Dosage 1
Arm Type
Experimental
Arm Description
25mg amniotic and umbilical cord matrix
Arm Title
AMUC Dosage 2
Arm Type
Experimental
Arm Description
50mg amniotic and umbilical cord matrix
Arm Title
AMUC Dosage 3
Arm Type
Experimental
Arm Description
100mg amniotic and umbilical cord matrix
Intervention Type
Other
Intervention Name(s)
amniotic and umbilical cord matrix
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in patient back pain determined by visual analog scale
Description
0 to 100mm, 100mm worst pain
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Change in quality of life determined by SF-36
Description
Short FormHealth Survey to evaluate quality of life across eight scales
Time Frame
3 and 6 months
Title
Change in patient back pain determined by visual analog scale
Description
0 to 100mm, 100mm worst pain
Time Frame
6 months
Title
Change in Oswestry Disability Index
Description
0 to 50, higher the percentile, the worse the perceived lower back pain
Time Frame
3 and 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Laser Spine Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
12. IPD Sharing Statement
Learn more about this trial
FLO for Discogenic Pain
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