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NCT04621799

Fibrin for Chronic Multi-level Discogenic Low Back Pain

Status unknown Phase 2, PHASE3 Last updated 9 November 2020
What this trial tests

Phase 2, PHASE3 trial testing Fibrin sealant in Low Back Pain in 400 participants. Status unknown.

Timeline
11 June 2018
Primary endpoint
31 December 2020
30 June 2021

Quick facts

Lead sponsorPauza, Kevin, MD
PhasePhase 2, PHASE3
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment400
Start date11 June 2018
Primary completion31 December 2020
Estimated completion30 June 2021
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Pauza, Kevin, MD

Who can join

Adults 18 to 80, any sex, with Low Back Pain or Disc Disease. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Intra-annular injections of non-autologous fibrin for moderate to severe chronic low back pain (LBP).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Development, Pathogenesis, and Regeneration of the Intervertebral Disc: Current and Future Insights Spanning Traditional to Omics Methods.
    Hickman TT, Rathan-Kumar S, Peck SH. · · 2022 · cited 40× · PMID 35359439 · DOI 10.3389/fcell.2022.841831

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing