Discogenic Back PainNCT03644251
FLO for Discogenic Pain
A study testing amniotic and umbilical cord matrix in people with Discogenic Back Pain, run by BioTissue Holdings, Inc at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Discogenic Back Pain
- What is being tested?
- amniotic and umbilical cord matrix
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Aug 2018to 4 Mar 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Discogenic Back Pain
- Being tested
- amniotic and umbilical cord matrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
amniotic and umbilical cord matrixOther
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.
| Study group | Role | What they receive |
|---|---|---|
| AMUC Dosage 1 | Experimental | 25mg amniotic and umbilical cord matrix Receives: Other: amniotic and umbilical cord matrix |
| AMUC Dosage 2 | Experimental | 50mg amniotic and umbilical cord matrix Receives: Other: amniotic and umbilical cord matrix |
| AMUC Dosage 3 | Experimental | 100mg amniotic and umbilical cord matrix Receives: Other: amniotic and umbilical cord matrix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in patient back pain determined by visual analog scale
0 to 100mm, 100mm worst pain
Measured: 3 months
Secondary outcomes (3)
Change in quality of life determined by SF-36
Short FormHealth Survey to evaluate quality of life across eight scales
Measured: 3 and 6 months
Change in patient back pain determined by visual analog scale
0 to 100mm, 100mm worst pain
Measured: 6 months
Change in Oswestry Disability Index
0 to 50, higher the percentile, the worse the perceived lower back pain
Measured: 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2018
- Study start13 Aug 2018
- Primary completion4 Mar 2019
- Study completion4 Mar 2019
Why it stopped: Study Site Ceased all Business Operations
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Discogenic Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioTissue Holdings, Inc
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03644251
- Sponsor's protocol ID
- CLARIX-CS003
- Status last verified
- Mar 2019
- First submitted
- 20 Aug 2018
- Last updated
- 15 Mar 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FLO Injection for Discogenic Pain
- ClinicalTrials.gov ID
- NCT03644251
- Acronym / sponsor ID
- CLARIX-CS003
- Conditions
- Discogenic Back Pain
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study Site Ceased all Business Operations
- Enrolment
- 3 participants (actual)
- Lead sponsor
- BioTissue Holdings, IncIndustry (pharma, biotech, devices)
- Study start
- 13 Aug 2018 (actual)
- Primary completion
- 4 Mar 2019 (actual)
- Study completion
- 4 Mar 2019 (actual)
- First posted
- 23 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| AMUC Dosage 1 | Experimental | Other: amniotic and umbilical cord matrix25mg amniotic and umbilical cord matrix |
| AMUC Dosage 2 | Experimental | Other: amniotic and umbilical cord matrix50mg amniotic and umbilical cord matrix |
| AMUC Dosage 3 | Experimental | Other: amniotic and umbilical cord matrix100mg amniotic and umbilical cord matrix |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| amniotic and umbilical cord matrixCryopreserved 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. | Other | AMUC Dosage 1, AMUC Dosage 2, AMUC Dosage 3 |
Primary outcome
Change in patient back pain determined by visual analog scale
Time frame: 3 months
0 to 100mm, 100mm worst pain
3 secondary outcomes
Change in quality of life determined by SF-36
Time frame: 3 and 6 months
Change in patient back pain determined by visual analog scale
Time frame: 6 months
Change in Oswestry Disability Index
Time frame: 3 and 6 months
Results and safety
The study was stopped early (reason given: Study Site Ceased all Business Operations). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing amniotic and umbilical cord matrix in people with Discogenic Back Pain, run by BioTissue Holdings, Inc at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 15 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Study Site Ceased all Business Operations). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in patient back pain determined by visual analog scale (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2019.