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Safety & Regulatory Status

What we will tell you before anything else

Stem cell and exosome therapy at Allure Stem Cell is investigational. This page explains exactly what that means, how we source and test cells, how consent works, and the claims you will never hear from us.

Regulatory status

The U.S. Food and Drug Administration has approved stem cell products only for a narrow set of blood and immune-system disorders. Every treatment offered by Allure Stem Cell is outside that set and is therefore investigational: not FDA-approved, not proven for any of the conditions discussed on this site, and offered only with informed consent under physician oversight.

What we will never claim

  • That a treatment cures, treats, or reverses any disease.
  • That a specific outcome or percentage improvement is likely for you.
  • That you should stop or reduce medication prescribed by another clinician.
  • That our cells are “FDA-approved”, “FDA-registered”, or “FDA-cleared”.

Sourcing and testing

Cells are allogeneic, from screened, consenting donors, primarily umbilical cord tissue, and expanded by a cGMP-compliant laboratory partner. Each batch is tested for viability, identity, sterility, and potency, and the certificate of analysis for your treatment is shared with you. We do not fabricate or alter laboratory documentation, and we will show you the original.

Consent and candidacy

Every patient has a free consultation first. We review your health history, current conditions, and medications, explain the state of the evidence for your situation, and decide together whether treatment is reasonable. Written informed consent is required before any protocol is scheduled. We decline to treat when we do not think it is appropriate.

Risks

IV infusions carry the usual risks of intravenous therapy: bruising, infection at the site, and rare allergic reactions. Injections may cause temporary pain or swelling at the site. Allogeneic MSCs are generally well tolerated, but long-term risks of investigational cell therapies are not fully characterised. All risks are reviewed at consultation and in the consent document.

Your privacy

Health information is handled under our HIPAA Notice of Privacy Practices. Please do not send medical record numbers or other sensitive identifiers through the website form; share them at your consultation.

Begin With a Conversation

Questions about safety?

Ask them at a free consultation. We would rather lose a booking than leave a question unanswered.

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