Chain of identity and chain of custody

Category: Cell manufacturing · Editorial Review: Updated 20 October 2026 · 3 minute read

Two related safeguards

Chain of identity links collected material and the final product to the correct person or donor. Chain of custody records who handles the material and where it moves through the process. These safeguards are especially important when cells are collected at one location, processed elsewhere, and returned for administration. A reliable pathway must preserve both identity and handling records.

Autologous does not remove the risk

When a treatment uses a person’s own cells, a labeling error could still result in the wrong product being delivered. Ask how the clinic checks identifiers at collection, shipment, receipt, and administration. The process should not rely on a patient remembering a vial’s appearance or a staff member recognizing a name. It should use a consistent verification system.

Why records matter later

Traceability can support investigation if a quality concern or unexpected reaction is reported. The patient should receive enough information to identify the administered product, including relevant lot or batch details where applicable. These records can also help a home clinician understand what was given. A generic invoice for stem cell therapy may be inadequate for later medical review.

A practical request

Before treatment, ask which identifiers will appear in the procedure record and who retains the manufacturing and transport documentation. Confirm how you can obtain the medical record after leaving Korea. These questions do not require access to every proprietary manufacturing detail; they seek a traceable account of the material actually administered and the team responsible for it.

Continue exploring

• Culture-expanded cells
• Cell count, viability, and dose
• Cell identity and purity
• Prepare your consultation checklist

Sources & further reading

• FDA — Quality Cell and Gene Therapy Products
• ISSCR — Guide to Stem Cell Treatments

Read alongside your treating specialist’s advice. Clinical eligibility, exact products and treatment plans require individual assessment.