Advancing clear, responsible pathways for provider-directed regenerative care and patient access.
What is at stake
Updated criteria under 21 CFR 1271.10(a), pursued by citizen petition
Patients seeking regenerative treatments, and the physicians deciding whether they can responsibly offer them.
Our writing
Regenerative Medicine
The announcement PHA issued on December 12, 2025, setting out its case for a cGMP-based federal pathway for certain adult stem cell products. It carries statements from PHA's founder, president and lead strategic advisor.
Get involved
If your organization has a stake in how this is decided, we would like to hear from you.
Clinical experience is what makes a regulatory argument land. Tell us what you are seeing.
Access questions are not abstract. Your account of them is evidence.
A small number of partners fund this work and sit in the working groups that shape it.