FLO for Discogenic Pain

TissueTech

Status: Terminated

Conditions: Discogenic Back Pain

Treatments: Other: amniotic and umbilical cord matrix

Study type: Interventional

Funder types: Industry

Identifiers

NCT03644251

CLARIX-CS003

Details and patient eligibility

About

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.

Enrollment: 3 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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3 participants in 3 patient groups

AMUC Dosage 1

Experimental group

Description:

25mg amniotic and umbilical cord matrix

Treatment:

Other: amniotic and umbilical cord matrix

AMUC Dosage 2

Experimental group

Description:

50mg amniotic and umbilical cord matrix

Treatment:

Other: amniotic and umbilical cord matrix

AMUC Dosage 3

Experimental group

Description:

100mg amniotic and umbilical cord matrix

Treatment:

Other: amniotic and umbilical cord matrix