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https://pmc.ncbi.nlm.nih.gov/articles/PMC9114801/
https://pmc.ncbi.nlm.nih.gov/articles/PMC10579796/
Here are NIH findings
Stem cell therapy for autistic children is experimental and not approved by the U.S. Food and Drug Administration (FDA). While international clinics and private entities offer the therapy and claim benefits, major health institutions and autism experts caution that the evidence for its effectiveness is limited, and the potential risks are significant.
Scientific basis and research findings
Initial studies and some ongoing research have explored the potential of stem cells, particularly umbilical cord-derived mesenchymal stem cells (MSCs), to address biological factors associated with autism spectrum disorder (ASD).
Targeting inflammation: Some research suggests that stem cell treatments may help reduce inflammation in the brain and gut, which has been linked to some ASD symptoms.
Promising early results: Small-scale studies, including a Phase I trial at Duke University using cord blood, have reported encouraging but cautious signs of improved social and communication skills.
Inconclusive evidence: A meta-analysis published in 2022 found that while stem cell therapy for ASD might be safe and effective, the evidence was compromised by small study sizes and a lack of standardized treatment protocols. More studies are needed to confirm the therapy's safety and efficacy.
Need for rigorous trials: A review of clinical trials as of 2019 found little evidence of effectiveness from well-designed controlled trials.
Regulatory status in the U.S.
In the United States, the FDA has not approved any stem cell therapy specifically for autism.
The FDA permits the use of regenerative medicine therapies for autism only within registered clinical trials, such as those conducted at Duke University.
Clinics offering stem cell therapies for autism outside of these trials are operating without FDA authorization, raising significant safety concerns.
Risks and dangers of unproven therapies
Experts warn that expensive, unregulated stem cell treatments can pose serious risks to children.
Lack of efficacy: Many studies have found insufficient evidence that stem cell therapy improves core autism symptoms.
Infection and immune rejection: Unregulated treatments increase the risk of infection, immune reactions, and potentially life-threatening complications.
Tumor growth: Some evidence suggests a theoretical risk that MSCs could promote the growth of existing tumors.
Ethical concerns: Clinics offering expensive, unproven treatments outside of clinical trials may exploit families' hope, as highlighted by a controversial agreement between Duke University and a private company that was later terminated.
What are the benefits and effectiveness of stem cell therapy for autism?
Based on the provided search results, there is no conclusive evidence about stem cell therapy as an established treatment for autism. The main evidence-based therapies currently used include:
• Speech therapy
• Behavioral therapy (including ABA)
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