Adiamed
1月前
Not sure why you're so negative about a company trying to help people! I'm trying to give MS patients an option I was never offered. I was told by my neurologist, three years ago that I would be in a wheelchair by now. I had AHSCT done two and a half years ago and in my opinion, I am cured. NO CANE, NO WALKER, NO WHEELCHAIR!
The reason I took over this company and am not receiving compensation is to help people like me.
That aren't aware of this option. That has proven to be Up to 95% successful.
You are absolutely correct, if you need to be approved under statute 351 you need the FDA trials and approval. We do not fall under statute 351. Adia falls under 361.
I think you need to do more research.
Please be kind to people trying to help others.
samson8
1月前
https://www.fda.gov/vaccines-blood-biologics/consumers-biologics/important-patient-and-consumer-information-about-regenerative-medicine-therapies
The US Food and Drug Administration (FDA) regulates regenerative medicine products. There continues to be broad marketing of unapproved products considered regenerative medicine therapies that are intended for the treatment or cure of a wide range of diseases or medical conditions. These products require FDA licensure/approval to be marketed to consumers. Before approval, these products require FDA oversight in a clinical trial. These unapproved products whether recovered from your own body or another person’s body, include stem cells, stromal vascular fraction (fat-derived cells), umbilical cord blood and/or cord blood stem cells1, amniotic fluid, Wharton’s jelly, ortho-biologics, and exosomes. FDA has received reports of blindness, tumor formation, infections, and more, detailed below, due to the use of these unapproved products.