An Observational Study of Human Umbilical Cord Tissue Allografts for Paraspinal Muscle and Entheses Defects in the Thoracic and Lumbar Regions

Introduction: With age and injury, the infiltration of fat in the paraspinal muscles can cause degeneration, disorganizing the structural integrity of the connective tissue and causing lower back pain (LBP). Human umbilical cord tissue allografts (UCTAs) have a collagen-rich matrix with various extracellular matrix (ECM) components that can replace damaged connective tissue. The objective of this paper is to analyze the preliminary findings from an observational repository on UCTAs for the supplementation of degenerated tissue in thoracic and lumbar paraspinal muscles refractory to standard conservative methods through patient-reported scales. Materials and Methods: A total of 117 patients from an observational repository were identified with paraspinal muscle degeneration. Patients received one to three applications of UCTAs; outcomes were tracked using the Numeric Pain Rating Scale (NPRS), the Western Ontario and McMaster University Arthritis Index (WOMAC), and the Quality-of-Life Scale (QOLS). Results: All groups showed positive improvement in the NPRS and WOMAC scales. Multi-application groups revealed statistically significant differences in the analyses. No adverse events or complications were reported. Discussion: Limitations included a lack of a control group, non-standardized application protocol, and the increase in recall and response bias due to using patient-reported measures. Conclusion: This pilot investigation presents the preliminary effectiveness necessary in hypothesis generation for continued research through randomized controlled trials to validate efficacy, establish optimal dosage protocols, and compare UCTAs to other conservative interventions.