Trials / Terminated
TerminatedNCT03644251
FLO for Discogenic Pain
FLO Injection for Discogenic Pain
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 3 (actual)
- Sponsor
- BioTissue Holdings, Inc · Industry
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2018-08-13
- Primary completion
- 2019-03-04
- Completion
- 2019-03-04
- First posted
- 2018-08-23
- Last updated
- 2019-03-15
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT03644251. Inclusion in this directory is not an endorsement.