Wholesale supply
Pilargo Foundation™ supplies on a wholesale basis to licensed medical practices and research institutions. We do not treat patients and we do not sell to the public.
What ships
A shipment is three things: the preparation itself, the document that describes it, and a record connecting the two. Any one of them without the others is not much use to a receiving practice. Lot number, date of manufacture and passage should reconcile across the vial, the certificate and the shipping record.
Product
Shipped on dry ice with temperature-monitored cold chain, for thaw and administration under the receiving physician's protocol.
Documentation
Batch-specific figures — marker phenotype, viability, counts — for the lot in the shipment. What it contains.
Traceability
Lot number, date of manufacture and passage, reconciled across vial, certificate and shipping record.
Context
In the published trials, patients received about 15 million cells as a single IV infusion, given over ten to fifteen minutes. That's the protocol the actual data — on both safety and outcomes — is based on.
Some commercial settings use higher doses or different delivery routes. Those choices go beyond what the trial evidence covers, rather than extending it — a distinction worth stating plainly in your own consent process.
Regulatory position
No Muse cell product holds marketing approval anywhere in the world. In the United States these preparations are investigational — they have not been approved by the FDA to diagnose, treat, cure or prevent any disease, and they are not approved for routine therapeutic use.
Investigational biological products are subject to FDA requirements, which in most circumstances include an Investigational New Drug (IND) application before a product may be used clinically. A state law permitting stem cell treatment does not displace that federal authority.
Confirm the regulatory basis for any proposed use — with your own counsel or regulatory advisor — before administering the product to a patient. What you may lawfully offer, and on what basis, is the receiving practice's determination to make. We cannot make it for you, and nothing on this page is legal advice.
Enquiries
Tell us your practice or institution, the volume you are considering, and the documentation you need to review before ordering. We will reply with current terms and a sample Certificate of Analysis.
830 S Main St Ste 2I, Cottonwood AZ 86326
Who we supply
Licensed medical practices, physicians, and research institutions. We are not able to supply individuals, and nothing on this site is an offer of treatment.
