STEM CELL THERAPY FOR CHRONIC FATIGUE SYNDROME: A PROMISING APPROACH

Deby Susanti Pada Vinski¹, Svetlana Trofimova², Jaime Rodriguez Quintosa³, Andi Kurniawan Nugroho⁴, CA Schroeter⁵, Stevan Jovanovic⁶

Celltech Stem Cell Centre Laboratory and Banking, Jakarta, Indonesia¹, Institute of Bioregulation and Gerontology, St. Petersburg, Russia², Efhre International University, Barcelona, Spain³, Universitas Semarang, Semarang, Indonesia⁴, Kastanienh of Clinic, Köln Junkersdorf, Germany⁵, Institut Médical de Champel, Geneva, Switzerland⁶

[email protected], [email protected], [email protected], [email protected], [email protected], [email protected]

ABSTRACT

Chronic Fatigue Syndrome (CFS), or Myalgic Encephalomyelitis (ME), is a debilitating condition marked by persistent fatigue, cognitive dysfunction, and chronic pain, severely affecting quality of life. This study explores the potential of mesenchymal stem cell (MSC) therapy as an innovative treatment for CFS. Using a qualitative descriptive design and case studies, data were gathered through interviews, medical record reviews, and observations of patients undergoing MSC therapy. The findings revealed significant improvements in fatigue, cognitive function, and physical well-being, with participants reporting better memory, concentration, reduced pain, and improved daily functioning. While some sleep disturbances persisted, their severity was reduced. These results highlight the potential of MSC therapy to alleviate CFS symptoms and enhance quality of life. Despite its promise, challenges such as high costs, regulatory hurdles, and the need for standardized protocols persist. Further research is required to confirm long-term efficacy and safety, contributing to the growing evidence for regenerative medicine in treating chronic conditions like CFS.

Keywords: chronic fatigue syndrome, immunomodulation, mesenchymal stem cells, regenerative medicine, stem cell therapy

Corresponding Author: Deby Susanti Pada Vinski

E-mail: [email protected]

INTRODUCTION

Chronic Fatigue Syndrome (CFS), also known as Myalgic Encephalomyelitis (ME), is a complex and debilitating condition characterized by persistent, severe fatigue that does not improve with rest and is often worsened by physical or mental exertion (Cockshell & Mathias, 2010; Karavitaki & Prete, 2024; Rowe et al., 2017). Despite extensive research, the pathophysiology of CFS remains poorly understood, limiting the development of effective treatments. Current therapeutic options provide only partial relief, emphasizing the urgent need for innovative approaches to manage CFS symptoms more effectively (Bested & Marshall, 2015; Carruthers et al., 2003).

Recent studies have suggested that stem cell therapy could offer a promising alternative for CFS management by targeting its underlying pathophysiological mechanisms, particularly immune dysregulation, and neuroinflammation (Jason & Sunnquist, 2018; Marshall-Gradisnik et al., 2016; Tomas et al., 2017). Mesenchymal stem cells (MSCs) have shown potential due to their immunomodulatory and regenerative properties, which may help alleviate the immune abnormalities seen in CFS patients (Cuerquis et al., 2014; Fan et al., 2020; Zhang et al., 2017). These characteristics position MSCs as a candidate for addressing the systemic inflammation and cellular dysfunction contributing to CFS pathology (Al-Dhalimy et al., 2023; Derafsh et al., 2023; Gou et al., 2024).

Despite the potential of MSC therapy, significant barriers to clinical implementation remain, such as variability in treatment protocols, high costs, and challenges in regulatory approval (Kodama et al., 2022; Rowe et al., 2017; Sapag et al., 2024; Vaheb et al., 2024). Although some clinical trials have yielded promising results, conclusive evidence on the efficacy of stem cell treatments for CFS is still lacking, underscoring the need for rigorous studies to establish standardized protocols and assess long-term safety and efficacy (Karavitaki & Prete, 2024). Given the limitations of current treatments, the urgency of exploring stem cell therapy for CFS cannot be overstated. With millions affected globally and limited therapeutic options, advancing research on alternative therapies has become crucial to improving patient quality of life (Abusalah et al., 2024; Cortes Rivera et al., 2019; Rahal et al., 2014). As the number of CFS patients continues to grow, the development of accessible and effective therapies is essential to reduce the burden of this chronic condition (Nguyen et al., 2017; Tomas et al., 2017).

Prior studies have examined the use of MSCs for various inflammatory and autoimmune diseases, revealing their potential to modulate immune responses and repair tissue damage. MSCs have been shown to inhibit the release of pro-inflammatory cytokines and promote tissue repair, which could benefit CFS patients with similar inflammatory profiles (Hoban et al., 2015; Tomas et al., 2017). However, research specifically investigating MSC therapy for CFS remains limited, with findings that are preliminary and in need of further validation (Jason & Sunnquist, 2018; Tomas et al., 2017).

This study aims to contribute to the growing field of stem cell research by providing a comprehensive evaluation of MSC therapy in the context of CFS, a relatively underexplored area. By focusing on the effects of MSCs on immune regulation, inflammation, and symptom relief in CFS, this research adds new insights to a field where MSCs have shown promise but lack extensive clinical application for this syndrome (Fan et al., 2020; Tomas et al., 2017; Zhang et al., 2017). This approach addresses the novelty of applying MSC therapy directly to CFS, moving beyond traditional therapies and potentially laying the groundwork for future regenerative medicine applications.

The primary objective of this study is to evaluate the therapeutic potential of MSCs in reducing fatigue and enhancing the quality of life for CFS patients (Mehrabadi et al., 2022). By examining the impact of MSCs on inflammation, immune dysregulation, and cellular dysfunction, this research aims to clarify how stem cell therapy may alleviate CFS symptoms and provide a foundation for the development of standardized MSC treatments. Ultimately, this research seeks to advance the understanding of mesenchymal stem cell (MSC) therapy's potential in managing Chronic Fatigue Syndrome (CFS) and its associated symptoms. By contributing new insights into the therapeutic impacts of MSCs, especially on immune modulation and symptom relief, this study aims to not only fill gaps in the current body of research but also guide future studies on standardized protocols and effective interventions. The anticipated outcomes of this research could provide actionable insights and recommendations for both future researchers and practitioners, enriching the field of regenerative medicine and offering a foundation for new approaches to CFS treatment.

METHOD

This study employs a qualitative descriptive research design to explore the potential of stem cell therapy for Chronic Fatigue Syndrome (CFS) (Elder et al., 2020). The qualitative descriptive method is particularly well-suited for providing a comprehensive summary of events in the everyday terms of those events. It allows for an in-depth exploration of participants’ experiences and the contextual factors influencing those experiences. This method focuses on capturing the phenomenon's essence under study without imposing predetermined theories or frameworks.

This research was carried out at the Celltech Stem Cell Center Laboratory and Banking with the Vinski Regenerative Center, the main stem cell therapy clinic from the Celltech Stem Cell Center laboratory located at Vinski Tower, Jl. Ciputat Raya No. 22 A Pondok Pinang, South Jakarta, Indonesia 12310. This research utilizes a case study approach to gain a deeper understanding of the impact of stem cell therapy on CFS. The case study method is an in-depth examination of a specific instance or case within its real-life context. It allows for a detailed exploration of complex issues and provides insights that might not be uncovered through other research methods.

This study selected a series of case studies based on specific criteria to provide insight into stem cell therapy's effects on individuals diagnosed with Chronic Fatigue Syndrome (CFS). The selection criteria included participants previously diagnosed with CFS and had undergone some form of stem cell therapy. This included various interventions focusing on mesenchymal stem cells (MSCs). The primary outcomes observed in these case studies were changes in participants' symptoms, quality of life, and overall well-being following the therapy.

Data collection employed multiple methods to capture a comprehensive understanding of each case. First, in-depth, semi-structured interviews were conducted with patients who had received stem cell therapy. These interviews were designed to explore each patient's experience with CFS, examining the perceived impact of the therapy on their symptoms and any resulting changes in their daily lives. The semi-structured nature of the interviews allowed for detailed exploration of personal experiences while maintaining consistency across cases. Additionally, medical records were reviewed for each patient, providing valuable information about the specifics of the stem cell therapy they received. This review included details about the type of stem cell therapy administered, dosage, and any clinical outcomes observed by healthcare providers. This medical context helped further to understand the connection between therapy type and patient outcomes.

Data analysis in this study followed a thematic approach to identify patterns and insights from qualitative data collected through interviews, medical records, and observations. Each participant’s data was coded and categorized according to key themes relevant to their symptom progression and response to mesenchymal stem cell therapy. This systematic analysis enabled a nuanced understanding of the therapy's impact on various CFS symptoms, such as fatigue, cognitive function, and pain levels. Additionally, triangulation was used to validate findings across data sources, ensuring reliability and consistency in the interpretation of results.

RESULTS AND DISCUSSION

Case Studies

In this case study, we examined a diverse group of participants diagnosed with Chronic Fatigue Syndrome (CFS) who underwent stem cell therapy. The participants were selected based on specific criteria to ensure a comprehensive understanding of the therapy’s impact. The following are the basic characteristics of the participants:

1. Participant 1:

a. Age: 45 years

b. Gender: Female

c. Duration of CFS: 7 years

d. Initial Symptoms: Severe fatigue, sleep disturbances, cognitive impairments, joint pain, frequent headaches

e. Type of Stem Cell Therapy: Mesenchymal Stem Cells (MSCs) derived from umbilical cord tissue

f. Comorbid Conditions: Mild depression and anxiety

g. Previous Treatments: Cognitive-behavioral therapy (CBT), graded exercise therapy (GET), and antidepressants (with minimal improvement)

2. Participant 2:

a. Age: 52 years

b. Gender: Male

c. Duration of CFS: 10 years

d. Initial Symptoms: Extreme fatigue, unrefreshing sleep, muscle pain, memory loss, and frequent sore throat.

e. Type of Stem Cell Therapy: Mesenchymal Stem Cells (MSCs) derived from umbilical cord tissue.

f. Comorbid Conditions: Hypertension and hypothyroidism.

g. Previous Treatments: Various pharmacological treatments, including stimulants and immune modulators, with limited success.

3. Participant 3:

a. Age: 38 years

b. Gender: Female

c. Duration of CFS: 5 years

d. Initial Symptoms: Persistent fatigue, cognitive dysfunction, post-exertional malaise, and muscle weakness.

e. Type of Stem Cell Therapy: Mesenchymal Stem Cells (MSCs) derived from umbilical cord tissue.

f. Comorbid Conditions: Irritable bowel syndrome (IBS) and fibromyalgia.

g. Previous Treatments: Nutritional supplements, alternative therapies, and pain management strategies with moderate symptom relief.

Symptoms and Progress After Stem Cell Therapy

Participant 1

Symptoms Before Therapy: Participant 1 reported severe, debilitating fatigue that prevented her from engaging in regular daily activities. Cognitive impairments made it difficult to concentrate, and she experienced persistent joint pain and headaches. Progress after therapy Within three months of therapy, Participant 1 noticed a significant reduction in fatigue and joint pain. Cognitive function improved, allowing her to return to part-time work. Headaches became less frequent, and her overall quality of life improved markedly. Sleep disturbances persisted but were less severe.

Participant 2

Symptoms Before Therapy: Participant 2 suffered from extreme fatigue, muscle pain, and cognitive issues, including memory loss. His sleep was unrefreshing, and he frequently experienced sore throats. Progress after six months of therapy, Participant 2 experienced a moderate reduction in fatigue and muscle pain. Cognitive symptoms, particularly memory loss, showed noticeable improvement. However, unrefreshing sleep and sore throats persisted, albeit with reduced frequency and intensity. He reported an enhanced ability to perform daily tasks and engage in mild physical activities.

Participant 3

Symptoms Before Therapy, Participant 3 struggled with persistent fatigue, cognitive dysfunction, muscle weakness, and post-exertional malaise. She also had co-occurring conditions like IBS and fibromyalgia, complicating her symptom management. Progress after therapy by four months post-therapy. Participant 3 reported significant improvements in fatigue and muscle strength, allowing her to engage in more physical activities without triggering severe post-exertional malaise. Cognitive function improved, particularly in terms of concentration and mental clarity. IBS symptoms also showed some improvement, though fibromyalgia-related pain remained a challenge.

Summary of Results

All participants experienced reduced fatigue levels following stem cell therapy, with each reporting varying degrees of improvement. This reduced fatigue contributed to a greater ability to engage in daily activities and enhanced overall well-being. Cognitive function also showed improvement, especially in memory, concentration, and mental clarity. Additionally, joint and muscle pain, which were prominent symptoms before therapy, decreased post-therapy, leading to better mobility and physical comfort. While there were some improvements in sleep quality, sleep disturbances persisted to a certain extent for all participants. Overall, participants generally reported a better quality of life, with increased energy levels and the ability to resume certain aspects of their previous lifestyles.

CONCLUSION

Stem cell therapy presents a promising approach to managing Chronic Fatigue Syndrome (CFS), addressing a critical need for effective treatments in the face of limited conventional options. This study highlights the potential of mesenchymal stem cells (MSCs) to alleviate key symptoms of CFS, including fatigue, cognitive dysfunction, and chronic pain, ultimately improving patients' quality of life. While these findings are encouraging, the study underscores the necessity for further research to establish standardized treatment protocols and assess long-term efficacy and safety.

Future research should focus on conducting large-scale, multicenter clinical trials to validate the therapeutic potential of MSCs for CFS. These studies should address the current challenges, such as variability in treatment outcomes, regulatory barriers, and issues related to cost and accessibility. Additionally, exploring the underlying mechanisms of MSC therapy, particularly its immunomodulatory and anti-inflammatory properties, could provide deeper insights into its effectiveness and optimize its application in treating CFS. Investigations into combining MSC therapy with other treatments, such as pharmacological or behavioral interventions, may also offer synergistic benefits. Ultimately, advancing stem cell research and overcoming the existing challenges could pave the way for integrating MSC therapy into routine clinical practice. This would benefit CFS patients and contribute to the broader field of regenerative medicine, enhancing therapeutic options for various chronic and debilitating conditions.

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