Petition for Immediate FDA Approval of Stem Cell Therapy for Autism: A National Crisis and Public Health Emergency

To the U.S. Food and Drug Administration (FDA) and the U.S. Department of Health & Human Services:

We, the undersigned, demand the immediate FDA approval of stem cell therapy for autism spectrum disorder (ASD) as our nation faces an unprecedented public health emergency. Autism has reached epedemic levels, affecting 1 in 36 children in the United States, and every day that passes without action leads to devastating consequences for the future of our country.

Families are in crisis, searching for effective treatments while being denied access to scientifically-backed stem cell therapy due to outdated regulations. Groundbreaking research from Duke University has demonstrated the potential of stem cell therapy to improve cognitive function, communication, and overall quality of life for individuals with autism. Yet, thousands of families remain unable to access this critical intervention.

We can no longer wait. This is a national emergency.

We demand the following immediate actions:

 1. Full FDA approval of stem cell therapy for autism as a recognized and accessible treatment nationwide.

 2. Standardized autism treatment protocols—All doctors specializing in stem cell therapy must follow the Duke University protocol, ensuring consistency, safety, and effectiveness, rather than limiting access solely to Cyro-Cell or select providers.

 3. Federal recognition of autism as a medical and national crisis, requiring urgent government action to expand access to innovative treatments that can change lives and the trajectory of our nation’s future.

If we do not act now, the long-term impact on our healthcare system, economy, and national stability will be irreversible. Families cannot wait years for bureaucratic approvals while their children suffer needlessly. Every day of delay is a lost opportunity for progress, healing, and hope.

This is an emergency. We demand immediate FDA approval of stem cell therapy for autism.

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