FLO for Discogenic Pain

FLO Injection for Discogenic Pain

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 Overview

• Status: Terminated
• Conditions: Discogenic Back Pain
• Intervention / Treatment: Other: amniotic and umbilical cord matrix

• Study Type: Interventional
• Enrollment (Actual): 3
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33607
      • Laser Spine Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: AMUC Dosage 1; 25mg amniotic and umbilical cord matrix	Other: amniotic and umbilical cord matrix; 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.
EXPERIMENTAL: AMUC Dosage 2; 50mg amniotic and umbilical cord matrix	Other: amniotic and umbilical cord matrix; 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.
EXPERIMENTAL: AMUC Dosage 3; 100mg amniotic and umbilical cord matrix	Other: amniotic and umbilical cord matrix; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Tissue Tech Inc.

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 13, 2018
• Primary Completion (ACTUAL): March 4, 2019
• Study Completion (ACTUAL): March 4, 2019

Study Registration Dates

• First Submitted: August 20, 2018
• First Submitted That Met QC Criteria: August 21, 2018
• First Posted (ACTUAL): August 23, 2018

Study Record Updates

• Last Update Posted (ACTUAL): March 15, 2019
• Last Update Submitted That Met QC Criteria: March 13, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain
• Other Study ID Numbers: CLARIX-CS003

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No