Regulatory Oversight

Regulatory Reality: Stem Cell Therapy & Autism

What families need to know about safety, regulation, and legitimacy

Close up of scientist with blue gloves using pipette and test tube in laboratory with FDA approval icons, representing food and drug administration, safety standards, clinical testing, and regulation.
FDA
Authorized IND
IRB
Approved Protocols
The Truth

When it comes to stem cell therapy for autism, where the cells come from, how they are regulated, how they are acquired, and how outcomes are tracked matters—everything else is noise.

BetterStem is the only organization in the United States providing stem cell treatments for Autism Spectrum Disorder using cells sourced from a laboratory operating under an FDA-authorized Investigational New Drug (IND) specifically for autism.

That distinction is not marketing—it is regulatory reality.

Here is the part families are rarely told:

If a laboratory does not hold an IND for autism, it is not legally permitted to commercialize or sell its stem cells for clinical use in autism.

Those cells may only be distributed for research purposes under tightly controlled conditions.

This means:

  • Labs without an autism-specific IND cannot legally commercialize their stem cells for IV use or autism treatment
  • Physicians purchasing those cells are not part of an authorized research pathway
  • There is no legal clinical framework governing how those cells are acquired, labeled, or intended to be used for ASD

Even more concerning...

Some clinics describe this practice as "off-label" use. This is inaccurate and misleading.

Off-label use applies only to FDA-approved drugs approved for another indication. Stem cells are not FDA-approved drugs for any indication, including autism. Without an IND, there is no lawful basis to represent these treatments as regulated clinical care.

At BetterStem, we do not cut corners

We do not rebrand loopholes, or operate in regulatory gray zones. Our model is built on:

Cells sourced from an IND-authorized laboratory with autism-specific research

IRB-approved treatment protocols

Lawful clinical acquisition and chain-of-custody of cellular products

FDA-registered sourcing, processing, and handling

Medical oversight with standardized safety monitoring

Longitudinal data tracking, including structured follow-up and outcome monitoring over time to evaluate safety signals, response patterns, and durability of outcomes

Families deserve facts, science, and accountability—not ambiguity.

That is why BetterStem exists—and why no other provider in this space can legitimately claim the same regulatory foundation.

Non-Compliant

❌ Commercial Stem Cell Sales

(What Most Clinics Use)

1

No IND for Autism

  • Cells were never studied or authorized for ASD
2

"Research Use Only" Products

  • Legally restricted to laboratory research—not patient treatment
3

Commercial Sale Outside a Clinical Framework

  • No FDA-sanctioned pathway for autism
  • No authorized research participation by the treating physician
4

Misleading Language

  • Often described as "off-label" despite no FDA approval existing
5

No Longitudinal Oversight

  • No structured follow-up
  • No standardized safety or outcome tracking

Result:

Regulatory gray zones, lack of transparency, and no meaningful accountability.

Choose Regulated Innovation

BetterStem is committed to providing families with safe, legal, and accountable access to advanced regenerative therapies for autism.

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