ISCT, PIC/S, ISO 15189, what the certifications actually mean.

Visit any regenerative-medicine clinic's website and you will see the same row of certifications repeated. ISCT, PIC/S-GMP, ISO 15189, sometimes ISO 9001 or AABB. They are not interchangeable. They test different parts of the operation, and a patient comparing two clinics is better served knowing what each one means than counting how many badges sit at the bottom of the page.

ISCT, what the cells are

The International Society for Cell & Gene Therapy publishes the criteria that define what counts as a mesenchymal stromal cell. Three pillars: plastic adherence in standard culture conditions, a specific surface-marker profile (positive for CD73, CD90, CD105; negative for haematopoietic and endothelial markers), and demonstrated tri-lineage differentiation potential.

ISCT alignment means a laboratory can prove the cells it is administering meet the standard definition of MSCs. Without that proof, 'MSC therapy' is a marketing claim rather than a defined product. This is the certification that anchors the chain of custody we have written about in autologous vs allogeneic, why our chain of custody matters.

PIC/S-GMP, how the cells are handled

PIC/S, the Pharmaceutical Inspection Co-operation Scheme, sets the Good Manufacturing Practice standard that pharmaceutical and cell-therapy facilities are inspected against. PIC/S-GMP compliance describes the cleanroom environment, the in-process controls, the equipment qualification, the change-control procedures, and the personnel training that govern how living cell products are produced.

If ISCT is about what the cells are, PIC/S-GMP is about how they are handled from harvest to release. A facility cannot be honestly PIC/S-GMP-compliant on paper alone; it requires the cleanroom build-out, the qualified personnel, and the documentation system that supports an inspection. This is the certification that matters most for sterility and identity at scale.

ISO 15189, what the laboratory measures

ISO 15189 is the international standard for medical laboratory quality and competence. It covers the testing your lab does on the cells before and after expansion, on the patient's blood and biomarkers, and on every release test that determines whether a cell product is safe to administer.

For a regenerative-medicine clinic, ISO 15189 matters because every cell product needs to be characterised, identity, viability, sterility, endotoxin, mycoplasma, and those tests are only as good as the laboratory running them. The same standard applies to the genetic-testing service we run, which is why we maintain ISO 15189:2022 across both functions.

What none of these certifications prove

None of these certifications proves that a given protocol is appropriate for a given patient. That is the clinical judgement of the physician sitting across from you, which is why we are explicit that the certifications are necessary, not sufficient. The certifications are the substrate. The judgement is the practice.

A clinic with the certifications and the cleanroom but without a hematologist reviewing every cell-therapy case, an orthopaedic consultant reviewing every OA injection, and a cardiology read on every post-stroke or post-MI patient is operating an excellent factory without a hospital around it. The whole clinical team exists because the certifications are where the work starts, not where it ends.

What this means for the patient

When evaluating a regenerative-medicine clinic, the right questions to ask are: where is the cleanroom; who is the responsible person for the PIC/S-GMP quality system; what are the ISCT release criteria for the cell product you are receiving; and what does the ISO 15189 scope cover, does it include the in-process testing on your cells, or only the patient bloodwork.

Most clinics will not answer all four questions clearly. The ones that do are the ones doing the work properly. The reason MSC products cannot be sold off the shelf, covered in are stem cells available for retail purchase like other pharmaceuticals, is exactly the same reason these certifications matter.