Question

Одобрена ли е терапията със стволови клетки за Разстройство от спектъра на аутизма от FDA?

Stem-cell therapy for autism is not FDA-approved. No autism-specific stem-cell product has completed pivotal trials in the USA or EU; all offerings are investigational. Some overseas clinics market treatments as 'approved' or 'clinically proven' — these claims are false and a warning sign. Any autism therapy offered outside a registered trial is experimental, whatever the marketing says.

How stem cells are studied for Autism Spectrum Disorder

Autism Spectrum Disorder stems from alterations in neuronal connectivity and immune signalling during neurodevelopment. Stem-cell research explores whether mesenchymal stem cells derived from placental tissue or amniotic membrane can modulate neuroinflammation, support synaptic plasticity, and promote neural integration. These cells are selected because they secrete immunoregulatory factors and can differentiate into supportive glial cells. Neurogenic cells are also being studied to repair damaged neural circuits, while exosomes — extracellular vesicles released by stem cells — are examined as vehicles for delivering anti-inflammatory signals to the brain. Current approaches remain investigational; the evidence base comprises preclinical work and early clinical trials. No mechanism yet explains why or how stem cells would alter the core neurobiological features of autism in humans.

Съм ли кандидат? → · Autism Spectrum Disorder: full overview → · Цена Разстройство от спектъра на аутизма → · Cost →

Медицински преглед от редакционния екип на StemCellAtlas с Kiian Nadiia, MD, PhD (Paediatric Neurologist · Medical Director, CSM Clinic Network · 12+ yrs in Autism Spectrum Disorders) на партньорската клиника Stem Plus (София), спрямо ISSCR, FDA и EMA указания. Educational information, not medical advice; figures indicative.

Клетъчна терапия на европейско ниво — без европейските цени.

GMP-сертифицирана регенеративна медицина в сърцето на ЕС — от 3 000–8 000 €, част от цените в САЩ или Германия. Персонализирани протоколи за пациенти от над 50 държави.

Безплатна медицинска оценка