Regenerative Therapies in the Management of Chronic Low Back Pain from Evidence to Practice: An Analytical Summary of the 2025 Comprehensive Evidence-Based Guidelines.

چکیده اصلی

BACKGROUND: Regenerative medicine is an evolving medical subspecialty dedicated to enhancing the body's natural healing mechanisms to repair or to replace damaged tissues. By using autologous or allogeneic biologics, it offers the potential to restore function where conventional therapies have shown limited success. While this field holds great promise and continues to generate enthusiasm among both patients and clinicians, it remains in early stages of clinical validation. Therefore, it must be approached with careful optimism and responsible application, ensuring that its presentation, promotion, and use in clinical settings are grounded in evidence and ethical standards. In 2025, the American Society of Interventional Pain Physicians (ASIPP) published updated comprehensive evidence-based guidelines. STUDY DESIGN: Summary and structured synthesis of a multidisciplinary, evidence-based clinical practice guideline developed by systematic literature review, dual-instrument methodologic quality appraisal, Grading of Recommendations Assessment, Development, and Evaluation (GRADE) certainty assessment, and modified Delphi consensus. OBJECTIVES: The present investigation summarizes the 2025 updated comprehensive evidence-based guidelines for regenerative therapies in the management of chronic low back pain published by ASIPP. The critical and analytical summary is organized around these recommendations, presenting for each underlying evidence, the assigned evidence level, the consensus-based clinical recommendation, and the practical consequences for patient selection, product preparation and dosing, procedural technique, regulatory compliance, and informed consent. METHODS: A multidisciplinary panel convened by ASIPP defined key clinical questions, reviewed relevant literature, formulated evidence-based statements, and reached consensus through structured discussion and formal voting. Methodologic quality of randomized trials was assessed with Cochrane review criteria and the Interventional Pain Management Techniques - Quality Appraisal of Reliability and Risk of Bias (IPM-QRB) instrument; nonrandomized studies were assessed with the Risk of Bias in Non-Randomized Studies of Exposure (ROBINS-E) tool and IPM-QRBNR. Evidence was graded on the 5-level modified ASIPP scale and appraised for certainty under GRADE. Consensus required at least 80% agreement among eligible panelists without a primary conflict of interest. RESULTS: Thirty-five authors contributed and 33 participated in the formal consensus process. Nineteen recommendations were generated, all achieving 100% agreement. Effectiveness recommendations were graded by anatomical target: lumbar intradiscal injections of platelet-rich plasma (PRP) and of bone marrow aspirate concentrate (BMAC) each carry Level III, fair evidence with a moderate consensus-based recommendation; lumbar epidural PRP injections carry Level III, fair evidence with a moderate recommendation; facet joint PRP and mesenchymal stem cell (MSC) injections carry Level IV, limited evidence with a moderate recommendation; sacroiliac joint PRP injections carry Level IV, limited evidence with a low recommendation; and functional spine unit multitarget injections carry very low evidence with a low recommendation. The remaining recommendations address available therapies and regulatory status, the risks of unapproved stem cell products, quality and standards for PRP and BMAC preparation, minimum quality control measures and platelet dosing, patient education, administration criteria, procedural risk stratification, and antithrombotic management. LIMITATIONS: The scarcity of high-quality studies, with much available evidence derived from small or heterogeneous trials. CONCLUSION: Regenerative therapies for chronic low back pain rely on fair evidence at the intervertebral disc and epidural space and limited evidence at evidence for facet and sacroiliac joints. The panel issued moderate consensus-based recommendations for all biologics in the lumbar spine, conditioned on definitive diagnosis, failure of conservative therapy, adherence to Food and Drug Administration (FDA) regulation, quantitative verification of the injectate, and transparent informed consent covering the experimental nature and out-of-pocket cost of these treatments.

متن کامل اصلی