FLO for Discogenic Pain

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

3 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-13

Study Completion Date

2019-03-04

Brief Summary

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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.

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Detailed Description

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Conditions

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Discogenic Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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AMUC Dosage 1

25mg amniotic and umbilical cord matrix

Group Type EXPERIMENTAL

amniotic and umbilical cord matrix

Intervention Type OTHER

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.

AMUC Dosage 2

50mg amniotic and umbilical cord matrix

Group Type EXPERIMENTAL

amniotic and umbilical cord matrix

Intervention Type OTHER

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.

AMUC Dosage 3

100mg amniotic and umbilical cord matrix

Group Type EXPERIMENTAL

amniotic and umbilical cord matrix

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No