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, causing lower back pain (LBP). Human umbilical cord tissue allografts (UCTa) have a collagen-rich matrix with various ECM components that can replace damaged connective tissue. The objective of this study is to evaluate preliminary findings on the safety and efficacy of UCTa for the supplementation of degenerated tissue in thoracic and lumbar paraspinal muscles refractory to standard conservative methods. Materials and Methods: A total of 141 patients from an observational repository were identified with paraspinal muscle degeneration. Patients received one to three applications of UCTa, outcomes were tracked using the Numeric Pain Rating Scale, the Western Ontario and McMaster University Arthritis Index, and the Quality-of-Life Scale. 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 and the increase of recall and response bias due to using patient-reported measures. Conclusion: This pilot investigation highlights the need for continued research through randomized controlled trials to validate efficacy, establish optimal dosage protocols, and compare UCTa to other conservative interventions.