Clinical Outcomes of Amniotic Membrane/Umbilical Cord Particulate in Spinal Disorders: A Retrospective Study.

ABSTRACT

Background: Musculoskeletal spinal disorders significantly impact patient populations from everyday workers to military soldiers. Effective treatment is critical to minimize the time between injury and returning to work and daily activities. Injection of amniotic membrane/umbilical cord (AMUC) tissue has demonstrated great potential in reducing patients' pain and has become an increasingly popular treatment option for painful orthopedic disorders. Methods: A single-center, retrospective study was conducted on patients diagnosed with musculoskeletal spinal disorders and subsequently treated with AMUC via epidural and facet injections. Demographics and outcomes related to pain were assessed. Pain was verbally reported by the patient on a scale of 0-10 where 0 indicated no pain and 10 indicated worst imaginable pain. Complications and adverse events were also reported. Results: A total of 52 patients (average age 40.8 ± 9.6 years) were included in the analysis with diagnoses of spondylosis (n = 44), intervertebral disc degeneration (n = 31), radiculopathy (n = 18), stenosis (n = 2), or other conditions. The cohort's average baseline pain score was 4.9 ± 2.2 with a mean duration of symptoms for 54.2 months (range 1-300 months). After AMUC injection, pain significantly decreased to 3.4 ± 2.3 at two weeks (p < 0.0001) and 3.5 ± 2.2 at 3-4 weeks (p = 0.0023). For the mean follow-up period of 10.6 ± 5.4 weeks, pain was reduced to 2.8 ± 2.1 (p < 0.0001 vs baseline). No significant complications or adverse events were reported. Conclusion: Use of an injectable AMUC, such as CLARIX FLO, may alleviate pain in patients with painful spinal indications of various pathologies. This study provides further evidence of its safety and efficacy in epidural and facet injections. Further studies are warranted to verify these promising results.