Erector Spinae Infiltration with Mesenchymal Stromal Cells in Chronic Lumbar Pain: A Case Report Series
Christian Díaz1, Manuel Padrón2, Vielka Benedito3, María Regis3, Catalina Gormaz3, Michelle Flores4, Yina Mojica4, Lisbeth Pineda4, Carlos Bracho4, Daniel Briggs5 and Carlos Díaz-Urriola6
1Medical Director, Auragens Clinic Program
2Medical Specialist – Anaesthesiology, Auragens Clinic Program
3Clinic Staff, Auragens Clinic Program
4Biotechnologist/Medical Technologist, Auragens Laboratory Program
5Chief Executive Officer, Auragens Clinic/Laboratory Program
6Chief Medical Officer/Laboratory Directory, Auragens Clinic/Laboratory Program
*Corresponding author: Dr. Christian Diaz, Medical Director, Auragens Clinical Program
Citation: Diaz C, Padron M, Benedito V, Regis M, Gormaz C, et al. (2024) Erector Spinae Infiltration with Mesenchymal Stromal Cells in Chronic Lumbar Pain: A Case Report Series. J Stem Cell Res. 5(2):1-16.
Received: June 10, 2024 | Published: July 10, 2024
Copyright© 2024 genesis pub by Diaz C, et al. CC BY-NC-ND 4.0 DEED. This is an open-access article distributed under the terms of the Creative Commons Attribution-Non Commercial-No Derivatives 4.0 International License.,This allows others distribute, remix, tweak, and build upon the work, even commercially, as long as they credit the authors for the original creation.
DOI: https://doi.org/10.52793/JSCR.2024.5(2)-60
Abstract
Chronic lumbar pain associated to multiple conditions including discopathy and facet arthropathy can significantly impact a patient’s quality of life requiring innovative treatment approaches that are safe, effective, and sustainable. This case study evaluates the safety and efficacy of regenerative medicine biologic products in the form of human umbilical cord Wharton’s Jelly derived mesenchymal stromal cells (hUC-MSC) and exosomes delivered intravenously and locally via erector spinae plane (ESP) block, for the relief of chronic lumbar pain.
Patients in this case review were treated via intravenous (IV) and local injections as protocolized by Auragens Clinic and were assessed prior to treatment and post treatment using the Visual Analogue Scale (VAS) to assess safety and efficacy of the intervention.
Our findings suggest that hUC-MSC cell therapies and exosome-based therapies are safe and significantly reduce pain, supporting their use as promising modalities for chronic pain management, opening opportunities for further investigation to elucidate clinical efficacy and specify indications for use.
Keywords
Mesenchymal Stromal Cells (MSC); Regenerative Medicine; Discopathies; Chronic Lumbar Pain; Visual Analogue Scale (VAS); Flow Cytometry; Electron Microscopy; Extracellular Vesicles (EVs); Erector Spinae Plane (ESP) Block; MSC-Derived Exosomes; Analgesia; Pain Management; Paravertebral Space; Epidural Space; Biologic Therapies; Case Report Series.
Introduction
Chronic lumbar pain is a prevalent and debilitating progressive condition often resulting from discopathies, facet joint arthropathies, or other underlying spinal disorders. Conventional treatments for pain management are mainly limited to pharmaceutical analgesics, physical therapy and in some cases surgical intervention, often these modalities fail or do not provide long-term relief. Many times, these options are unsustainable for patients that may experience adverse effects associated to medication or who may not be candidate for corrective surgeries, this underscores the need for novel approaches.
Regenerative medicine is a growing field in biomedical and clinical practices which seeks to harness the biologic output of living cells and extracellular vesicles to replace or improve the function of damaged tissues.
Mesenchymal stromal cells from varying sources have recently gained much attention in the field given the noteworthy anti-inflammatory, immune-modulatory and regenerative characteristics of their extracellular vesicles (EVs) also know as exosomes. Wharton’s Jelly derived MSC have championed therapeutic strategies for chronic pain and inflammatory pathologies as they are easily isolated and ethically harvested from perinatal tissues which are otherwise considered medical or biologic “waste”. Also of importance, exosomes play a crucial role in cell-cell communication and could be key in mediating the regenerative processes necessary for pain relief.
The erector spinae plane block (ESP) is a relatively new technique in regional anesthesia and pain management that has proven of great benefit for short term pain relief and post-operatory pain management. This procedure targets the fascial plane between the erector spinae muscle and transverse processes of the vertebrae. While the exact mechanism of action is not fully understood, evidence indicates a diffusion of local anesthetic into adjacent paravertebral and epidural spaces. This diffusion likely influences both somatic and sympathetic pain pathways, effectively impeding the transmission of pain signals from the dorsal and ventral rami of spinal nerves to the central nervous system [1]. This procedure has been effectively used in various surgical contexts, such as thoracic, breast and orthopedic surgery, highlighting its versatility and efficacy in pain management including post operative pain control after spine surgery [2-4].
Our treatment protocol integrates the ESP block technique replacing local anesthetics with mesenchymal stromal cell products leveraging the targeted delivery and therapeutic effects respectively to treat patients with chronic lumbar pain aiming to achieve a more sustainable pain relief through regenerative medicine.
Figure 1: A visual depiction of the ESP block technique: the needle is being guided by ultrasound between the erector spinae muscle group and the transverse process. Once it reaches the transverse process, local anesthetic solution is administered.
Methods & Protocol Design
This case report series was conducted to describe the safety and efficacy of MSC administered intravenously along with exosomes delivered via ESP infiltration for the management of chronic lumbar spinal pain. The case report series details the medical histories, treatment protocols and post-treatment follow-up evaluations using the VAS to assess pain levels and functional outcomes of four patients labeled Patients A, B, C, and D in this study.
The isolation of MSC from human umbilical cord involved a series of steps with stringent quality control measures to ensure the safety and efficacy of the cells for clinical application. These steps were conducted in a GMP-grade ISO7 cleanroom in accordance with the International Cellular Therapy (ISCT) guidelines. Collection, dissection, enzymatic digestion, filtration and centrifugation as well as culture expansion and harvesting were all performed at Auragens Laboratory facility. MSC were characterized using flowcytometry to confirm surface expression markers (CD90, CD105, CD73, and CD44) and the absence of hematopoietic markers (CD34, CD11b, CD45, CD19) and HLA-DR. Quality control criteria were measured via viability quantification, sterility and endotoxin testing, cryopreservation, thawing and syringe preparation. MSC-derived exosomes were isolated and purified from the culture media of these cells using ultracentrifugation techniques and quantified using electron microscopy and size exclusion criteria of 80 to 130nm in size.
This methodology provides a detailed blueprint for investigating the efficacy of MSC and MSC- derived exosomes in treating chronic spinal pain through ESP blocks. This descriptive analisis aims to contribute valuable data to the field of regenerative medicine, offering insights into new pain management strategies for patients with discopathies.
Image 1: Human umbilical cord mesenchymal stem cells (hUC-MSC) observed under optical microscopy day 36 of culture expansion.
