Does GHA accreditation mean a
stem cell therapy is approved or proven?

No. GHA accreditation evaluates the organization delivering care, not the therapy itself. It confers no regulatory approval and makes no claim that any cell-based treatment is effective for any condition. What accreditation assesses is whether the organization documents regulatory status honestly, classifies evidence properly, and discloses investigational status to patients before treatment.

What is chain of identity and chain of
custody in cell therapy?

Chain of identity is the documented link between a cellular product and the specific donor it came from and the specific patient who receives it. Chain of custody records every transfer, handling step, and storage condition along the way. Together they make it possible to trace a product in both directions — essential for recalls, adverse-event investigation, and donor protection.

Does GHA accredit clinics offering unapproved or investigational treatments?

GHA does not accredit organizations that misrepresent regulatory status or make claims unsupported by evidence. Where a therapy is investigational or offered under a lawful exception, standards require that this be documented, disclosed in consent, and reflected accurately in marketing. Accreditation is refused where an organization cannot demonstrate that discipline.

Do we still need GHA accreditation if we hold FACT, JACIE, AABB, or ISO 15189?

Those credentials address laboratory and cell-processing quality. GHA evaluates the clinical organization: governance, patient selection, informed consent, claims integrity, cross-border compliance, and outcomes. Where you already hold a recognized credential, qualifying evidence may satisfy mapped GHA requirements, so the assessment focuses on the gaps rather than repeating verified work.

Does accreditation cover patients who travel internationally for treatment?

Yes. Cross-border and regulatory compliance is an assessed domain. Standards address the legal framework in each jurisdiction of operation, the movement of cellular products across borders, consent for patients treated away from home, and continuity of follow-up once a patient returns to their own country.

What does GHA evaluate about where
cells come from?

Cell and biologic sourcing is assessed end to end: verified product origin and tissue type, donor eligibility screening and testing, documented informed donor consent, protections against coercive or undisclosed procurement, supplier qualification and auditing, and bidirectional traceability linking donor, product, and recipient.

How long is GHA Regenerative Medicine Accreditation valid?

Accreditation is valid for 1 year, subject to interim reporting and to notification of material changes in scope, ownership, suppliers, or the therapies offered. Organizations undergo reassessment before expiry.

What is the difference between GHA regenerative medicine accreditation and cellular therapy laboratory certification?

Accreditation is for organizations that treat patients. Certification is for laboratories that manufacture, process, characterize, store, or supply cellular products. An organization doing both may hold both. The two programs assess different risks, and neither substitutes for the other.