Intradiscal injection of fibrin sealant for the treatment of symptomatic lumbar internal disc disruption: results of a prospective multicenter pilot study with 24-month follow-up

Pain Med. 2014 Jan;15(1):16-31. doi: 10.1111/pme.12249. Epub 2013 Oct 23.


Objective: Assess the safety and efficacy of intradiscal fibrin sealant in adults with chronic discogenic low back pain.

Design: Prospective, nonrandomized Food and Drug Administration approved pilot study.

Setting: Three centers in the United States.

Subjects: Fifteen adults with chronic, single, or contiguous two-level lumbar discogenic pain confirmed through meticulous provocation discography.

Interventions: Volume- and pressure-controlled intradiscal delivery of BIOSTAT BIOLOGX(®) Fibrin Sealant with the Biostat(®) Delivery Device into symptomatic lumbar disc(s).

Outcome measures: Assessments were performed at baseline, 72 hours, and 1, 4, 13, 26, 52, and 104 weeks following intervention. Potential adverse events were evaluated with serial assessment of neurological status, radiographic, and magnetic resonance imaging (MRI). Efficacy measures included serial assessments of low back pain visual analog scale (VAS) measurements and the Roland-Morris Disability Questionnaire (RMDQ).

Results: Safety neurological assessments, X-ray, and MRI showed no significant changes. Adverse events were reported in nine subjects. Two instances of low back muscle spasm and one case of discitis were the only events considered related to the procedure or product.

Efficacy: Mean low back pain VAS scores (mm) decreased from 72.4 (95% confidence interval 64.6-80.3) at baseline to 31.7 (17.4-46.1), 35.4 (17.7-53.1), and 33.0 (16.3-49.6); mean RMDQ score improved from 15.2 (12.7-17.7) at baseline to 8.9 (5.3-12.5), 6.2 (3.4-9.1), and 5.6 (2.9-8.4) at 26, 52, and 104 weeks, respectively.

Conclusion: Intradiscal injection of BIOSTAT BIOLOGX Fibrin Sealant with the Biostat Delivery Device appears safe and may improve pain and function in selected patients with discogenic pain.

Keywords: Discogenic Pain; Fibrin Sealant; Injection; Intervertebral Disc; Low Back Pain.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Disability Evaluation
  • Discitis / chemically induced
  • Female
  • Fibrin Tissue Adhesive / administration & dosage
  • Fibrin Tissue Adhesive / adverse effects
  • Fibrin Tissue Adhesive / therapeutic use*
  • Follow-Up Studies
  • Humans
  • Injections, Intralesional
  • Intervertebral Disc Displacement / complications
  • Intervertebral Disc Displacement / diagnostic imaging
  • Intervertebral Disc Displacement / drug therapy*
  • Intervertebral Disc Displacement / pathology
  • Low Back Pain / diagnostic imaging
  • Low Back Pain / etiology*
  • Low Back Pain / pathology
  • Lumbar Vertebrae* / diagnostic imaging
  • Magnetic Resonance Imaging
  • Male
  • Middle Aged
  • Pain Measurement
  • Pilot Projects
  • Prospective Studies
  • Radiography
  • Spasm / chemically induced
  • Surveys and Questionnaires
  • Young Adult


  • Fibrin Tissue Adhesive