Stem cell glossary: plain English first.

Cells that come from someone else, not from you. Our stem cells are always donor cells, of three types: umbilical-cord MSCs most often, donor bone-marrow MSCs, and chondrocytes. The donor and recipient are different people.

See also: Why these cells · Counts, viability, and dose

Medication that puts you to sleep or numbs you for a procedure. For our IV infusion, you are awake the entire time, no anesthesia required. We mention it here because we treat in a hospital where anesthesia is in the same building in case of an emergency, which is different from a freestanding clinic.

See also: What “hospital setting” means

Cells that come from you, processed, and given back to you. Autologous treatments are the U.S. wellness-clinic standard for "stem cell" therapy: bone marrow aspirate, adipose SVF, PRP. Our stem cells are never autologous: they are always donor cells. The only thing we prepare from your own blood is PRP.

See also: Allogeneic vs. autologous

A specific manufacturing run of cells, with a unique number. If something goes wrong on Patient 47, we can trace it to the same lot every other patient that week got their cells from. The lot number is on your Certificate of Analysis.

See also: What cGMP means

A drug made from a living source (cells, blood, antibodies) rather than from chemical synthesis. Our cells are a biologic. Vaccines, insulin, and monoclonal antibodies are also biologics. Regulated more heavily than small-molecule drugs.

See also: How we compare

A one-page document that comes with your specific lot of cells. It lists the cell count and the results of the six release tests (sterility, identity, viability, potency, endotoxin, mycoplasma), each signed off by the QA director at the lab. Available on request through your patient coordinator. If a clinic has no CoA process at all, ask why.

See also: The testing panel · What cGMP means

"Current Good Manufacturing Practice." A set of legally-enforced rules for how drugs (including cell therapies) must be made: clean rooms, trained staff, signed batch records, every step documented. Each country writes its own version. This is the standard our cells are made to.

See also: What cGMP means

Mexico's federal health regulator. Stands for Comisión Federal para la Protección contra Riesgos Sanitarios. Celva's care is regulated by COFEPRIS.

See also: Why Mexico · What cGMP means

Freezing cells so they can be stored and shipped. Cells are frozen in a special solution (which keeps ice crystals from forming inside them) and stored below −150 °C, in the cold vapor above liquid nitrogen (the liquid itself is −196 °C). Ours are banked, then thawed and re-checked the morning of treatment.

See also: Counts, viability, and dose

A signaling molecule that cells release to communicate with the immune system. Most of what our cells do happens through cytokines: they don't graft into your tissue, they release these signals that calm down inflammation and tell your own cells to repair.

See also: How the cells work

A toxic component of certain bacteria that can cause fever and shock if it gets into your bloodstream, even if the bacteria themselves have been killed. Every lot of our cells is tested for endotoxin at release, and the level has to be below a hard threshold.

See also: The testing panel

A tiny membrane-bound vesicle that cells release, packed with signaling cargo. Exosomes are not cells: they're subcellular particles. Some U.S. wellness clinics market "exosome IVs" as an alternative to stem cells. We use exosomes selectively. The biology is real, but an exosome product and a cell product are not the same thing.

See also: How we compare with Ways2Well

The U.S. federal regulator for drugs, biologics, and medical devices. Our cell product is not FDA-approved. That's the legal reason we're in Mexico, not California.

See also: Why leave the U.S.

The instrument that counts the cells in your lot. It passes the cells one at a time through a laser and a detector and counts every one of them, millions per minute. The cell count on a CoA comes from this machine. A CoA might read "200 million viable cells". That figure is only an example: your dose is set by your weight.

See also: The testing panel

The FDA's term for cells and tissues used as medical products: sperm, eggs, corneas, bone-marrow grafts, SVF. There's a "low-regulation" tier (§361) for minimally-processed tissue used in obvious ways, and a "biologic-drug" tier (§351) for everything else. Most U.S. "stem cell" clinics say they operate in the §361 tier. Our cells would be §351.

See also: How we compare

An FDA term meaning "using a tissue for the job it was originally doing." Bone graft → bone repair = homologous. Fat-derived cells → joint repair = not homologous. Most "stem cell" indications fail this test, which is why the FDA has been issuing warning letters to U.S. clinics.

See also: Why leave the U.S.

The FDA permission a company needs before they can give a new drug or cell therapy to humans in the U.S., even in a clinical trial. The FDA has 30 days to review an IND before the trial may start. The road from there to an approved product is what takes years.

See also: Why leave the U.S.

The legal and ethical process of making sure you understand what you're agreeing to before a medical procedure: risks, alternatives, what's known and what isn't. Ours is reviewed with you on the day of treatment, during check-in, before anything is given.

See also: Patient & family experience

A photograph of a cell's chromosomes. It confirms the cells still have the normal 46 human chromosomes, in the normal arrangement. We karyotype when a cell bank is made; it is not one of the six release tests run on each batch. A karyotype change would be a stop-the-line event.

See also: The testing panel

The test for endotoxin. The reagent comes from horseshoe-crab blood, which clots in the presence of bacterial endotoxin even at incredibly low concentrations. It's how we know the IV bag isn't going to give you a fever.

See also: The testing panel

The original frozen "seed" stock of cells, made once from a single donor's tissue (for our umbilical-cord cells, one donated cord), characterized exhaustively, and used to seed every subsequent working bank. One donor → one MCB → many lots → many patients. If anything ever looks off in a lot, we go back to the MCB to confirm the starting material was fine.

See also: Counts, viability, and dose

The main cell type we use. MSCs are a kind of adult stem cell (not embryonic, not pluripotent) that lives in your bone marrow, fat, umbilical cord, and other connective tissues. They release the cytokines that calm inflammation and signal repair. The official term is "stromal cell" (rather than "stem cell") because they don't make every tissue type: they make stromal tissues plus signaling.

See also: Why these cells

An FDA term meaning "the processing has not changed what the tissue or cells are." Centrifuging, washing, freezing and thawing = minimal. Culturing cells and expanding them = not minimal. Most U.S. wellness clinics are bound by this rule. Our cells fail this test (because we culture them), which is why we cannot operate in the U.S.

See also: Why leave the U.S.

A tiny bacterium with no cell wall. It's the most common contaminant of cell-culture labs because it slips through normal sterile-filtration. Every batch is tested for mycoplasma at release. A positive result discards the lot.

See also: The testing panel

"Signaling to your neighbors." This is the primary mechanism of action for our cells. They don't graft. They don't become you. They circulate, settle in inflamed tissue, release signaling molecules into the local environment, and a few weeks later most of them are gone, but the signals they sent have changed how nearby cells behave.

See also: How the cells work

How many times the cells have been split and re-plated since the original sample. Each round of expansion = +1 passage. Lower is better. Cells passaged many times slow down and lose signaling potency. In published work on bone-marrow MSCs the change shows by about passages 6 to 7; cord-derived cells tolerate more.

See also: Counts, viability, and dose

"Able to become any cell type in the body." Embryonic stem cells are pluripotent. Our cells are not pluripotent: they're multipotent, which is one tier down. This matters because pluripotent cells carry tumor-formation risk that multipotent cells do not.

See also: Why these cells

A test that measures whether the cells actually do what they're supposed to do, not just whether they're alive. Cell count and viability tell you the cells exist. The potency assay tells you they work. For MSCs, the assay measures whether they suppress T-cell activation in a dish.

See also: The testing panel

A concentrated preparation of your own platelets, made by spinning your blood in a centrifuge. PRP is autologous and commonly used by orthopedists. We offer it, made from your own blood on the day. It is not the same thing as a stem cell therapy.

See also: How we compare with Ways2Well

A clinical trial in which patients are randomly assigned to the treatment or to a control (often placebo). RCTs are the gold standard of clinical evidence because they neutralize bias in who gets which treatment. The phase-2 and phase-3 MSC literature has a small number of RCTs and a much larger number of registry / single-arm studies.

See also: Reading research

The set of tests every lot of cells must pass before it can be released for human use. We run six: sterility, identity, viability, potency, endotoxin, mycoplasma. Each one has a hard threshold; any single failure discards the lot. A batch is released only after the 14-day sterility result.

See also: The testing panel

The FDA's "low-regulation" tier for human tissue products. To qualify, the tissue must be minimally manipulated, used homologously, not combined with a drug, and either have no systemic effect or be used in the same person, in a close blood relative, or for reproduction. Most U.S. "stem cell" clinics say they operate here. Our cells do not qualify and would require §351 biologic-drug approval.

See also: How we compare

The release test that asks: "is anything alive in this bag besides our cells?" We sample the final product, incubate the sample in growth medium for 14 days, and check for bacterial or fungal growth. Any growth → the lot is destroyed.

See also: The testing panel

A cell mixture obtained by breaking down fat tissue, usually with enzymes. Contains a few MSCs alongside many other cell types. SVF is autologous, and many U.S. wellness clinics offer it the same day. The FDA treats it as more than minimally manipulated, which makes it a drug, and two federal appeals courts have agreed. It is not the same product as a characterized, expanded MSC infusion.

See also: How we compare

Residual amounts of reagents used during cell manufacturing (culture-medium components, growth factors, the cryoprotectant DMSO) that have to be measured and kept below safe thresholds. The final product is mostly cells in saline, but trace amounts of every reagent that ever touched them have to be characterized.

See also: The testing panel

The capacity of a cell to form a tumor. MSCs are not tumorigenic in any of the published data we work from: systematic reviews of MSC clinical trials have found no link between MSC infusion and malignancy. We test for it anyway at the master cell bank stage because we'd rather over-test than miss it.

See also: When something goes wrong

A mesenchymal stromal cell isolated from the umbilical cord, specifically from Wharton's jelly, the gel-like tissue inside the cord. This is the cell we use most often. We also use donor bone-marrow MSCs and chondrocytes. Cords are donated after term healthy births, with consent from the mother, and would otherwise be discarded.

See also: Why these cells

The percentage of cells in a lot that are actually alive when you measure them. Our release threshold is ≥95%. Anything lower and the lot is discarded. It is checked after thaw, right before treatment.

See also: The testing panel

The clear, gel-like connective tissue inside the umbilical cord. It cushions the blood vessels that run between mother and baby. It's the tissue our umbilical-cord cells come from. Wharton's jelly is rich in MSCs and is the standard source for cGMP UC-MSC programs. Named after the 17th-century English physician Thomas Wharton.

See also: Why these cells