No cell therapy for fibromyalgia has FDA approval or even phase II trial status in the United States. The field is entirely pre-regulatory, and most centres offering treatment operate outside formal clinical trial frameworks.
Fibromyalgia is a disorder of central pain processing characterised by widespread musculoskeletal pain, fatigue, and sleep disturbance, often accompanied by cognitive difficulties ('fibro fog'). No primary tissue damage is evident; instead, dysregulation of pain-signal amplification in the spinal cord and brain—low serotonin, elevated substance P, sensitised pain receptors—perpetuates the syndrome. The condition predominantly affects women and is often triggered by trauma, infection, or stress. Cell therapy exploration in fibromyalgia is nascent; placental MSCs and their secreted exosomes are being investigated for immunomodulatory properties (shifting immune response away from pro-inflammatory cytokine production) and for potential neuromodulation through delivery of anti-inflammatory molecules to the central nervous system. The hypothesis is that systemic cellular or exosome infusion might dampen the amplified pain state and restore normal sleep and mood regulation.
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由 StemCellAtlas 的编辑团队进行医学审查，与Kiian Nadiia, MD, PhD (Paediatric Neurologist · Medical Director, CSM Clinic Network · 12+ yrs in Autism Spectrum Disorders) 合作诊所 Stem Plus（索菲亚）的，根据 ISSCR、FDA 和 EMA 指南。 Educational information, not medical advice; figures indicative.
位于欧盟核心的 GMP 认证再生医学诊所——费用 3,000–8,000 欧元起，仅为美国或德国价格的一小部分。为来自 50 多个国家的国际患者提供个性化方案。
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