Intrathecal injection incurs 24–48 hours of hospitalisation; post-dural-puncture headache occurs in 10–15% and resolves within 1 week in most. Transient CSF pleocytosis and meningeal irritation (mild back pain, neck stiffness) occur in <5% and resolve within days. Functional assessment establishes baselines at 6–8 weeks; plateau or deceleration of decline becomes apparent at 3+ months. Patients continue riluzole and other supportive ALS medications; no modification is recommended without neurology consensus.
Clinical trial safety data across >500 ALS recipients shows no treatment-limiting adverse events from intrathecal or intravenous cell infusion. Efficacy signals emerge from small phase II cohorts: decline in ALSFRS-R (disease rating scale) is slowed by 30–50% over 12 months in 30–45% of treated patients versus untreated historical controls; some maintain muscle strength for 6–12 months longer than expected disease trajectory. Markers of neuroinflammation (CSF cytokine levels, microglial activation on PET imaging) decline in responder subgroups. No completed pivotal trial has demonstrated survival prolongation; two large multi-centre efficacy trials are recruiting.
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Medizinisch geprüft vom Redaktionsteam von StemCellAtlas zusammen mit Kiian Nadiia, MD, PhD (Paediatric Neurologist · Medical Director, CSM Clinic Network · 12+ yrs in Autism Spectrum Disorders) der Partnerklinik Stem Plus (Sofia), gemäß ISSCR-, FDA- und EMA-Leitlinien. Educational information, not medical advice; figures indicative.
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