§ R.1 · Reference · 36 terms

Glossary.

Every term that matters in cell therapy. Plain-English on top, technical underneath, for when you need the textbook version.

Term of the moment Paracrine, signaling to your neighbors
36
Total entries
5
Topic silos
19
Letters covered
R.1
Reference · vol. 1
▸ How to use this page

The plain-English version on top.

Every entry has two definitions. The top one is the one we use in conversation with patients, the version you'd hear in a consult, in language you'd use to a friend. The bottom one (in the grey box) is the technical definition you'd find in a regulatory document or a textbook, included for the patients, physicians, and journalists who want to cross-reference.

The "See also" line at the foot of each entry points to the article in the Learn library where the term is used in context. The colored topic chip on the left tells you which silo it belongs to: biology, manufacturing, regulatory, clinical, or cost.

§ A note on plainness

Some of these terms have technical meanings that diverge from how they're used in advertising. We use the technical meaning. When a clinic markets "stem cells" but does not specify cell type, count, or viability. we treat that as advertising language, not biology. The biology is what's in the grey boxes.

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A
3 entries · Allogeneic · Anesthesia · Autologous
Allogeneic
a-loh-JEN-ik · adj.
Biology

Cells that come from someone else, not from you. Our cells are allogeneic, donor-derived: umbilical cord most often, with adult donor bone marrow for orthopedic and structural cases. The donor and recipient are different people.

TechnicalDerived from a genetically non-identical individual of the same species. Allogeneic MSCs are non-immunogenic at low passage and do not require HLA matching for IV infusion in most indications.
Anesthesia
an-es-THEE-zhuh · n.
Clinical

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 on the same floor in case of an emergency, which is different from a freestanding clinic.

TechnicalPharmacological induction of analgesia, sedation, or unconsciousness. IV-MSC infusion does not require sedation; on-site anesthesia capacity is a setting-of-care marker, not a procedure requirement.
Autologous
aw-TOL-uh-gus · adj.
Biology

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. We do not use autologous cells; ours are allogeneic.

TechnicalDerived from the same individual receiving the cells. Most U.S. §361 HCT/P-tier procedures (BMA, SVF, PRP) are autologous; the FDA framework constrains processing complexity for autologous products.
B
2 entries · Batch / Lot · Biologic
Batch / Lot
n. · "lot number"
Manufacturing

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.

TechnicalSpecific quantity of cell-therapy product produced under uniform conditions, identified by a unique batch record and lot number. Required under cGMP for traceability and recall capacity. One UC-MSC donor cord yields one master cell bank → multiple lots.
See also: §3.5 cGMP
Biologic
by-uh-LAH-jik · n.
Regulatory

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.

TechnicalPer 21 U.S.C. § 262: a virus, therapeutic serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, or analogous product applicable to the prevention, treatment, or cure of a disease in humans. Cell therapies fall under biologics regulation in most jurisdictions.
See also: §6.3
C
5 entries · CoA · COFEPRIS · Cytokine · cGMP · Cryopreservation
Certificate of Analysis
CoA · n.
Manufacturing

A one-page document that comes with your specific lot of cells. It lists the cell count, viability, sterility-test result, and seven other release tests, each signed off by the QA director at the lab. Available on request through your case coordinator. If a clinic has no CoA process at all, ask why.

TechnicalQuality-document attestation per ICH Q7. For UC-MSCs: cell count (flow cytometry), viability (7-AAD), sterility (USP <71>), mycoplasma (USP <63>), endotoxin (LAL), identity (CD73/CD90/CD105 +ve, CD34/CD45 -ve), potency (IDO induction or T-cell suppression), karyotype (G-band).
cGMP
"see-jee-em-pee" · n.
ManufacturingRegulatory

"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. Same rules in the U.S., Mexico, EU, and most of the world. This is the standard our cells are made to.

Technical21 CFR 210 / 211 in the U.S.; equivalent COFEPRIS / EU Annex 1 frameworks internationally. Mandates ISO 7 / Grade B background, ISO 5 / Grade A processing under unidirectional flow, environmental monitoring, gowning, in-process controls, and document-controlled batch records. Audit-inspected.
COFEPRIS
koh-FEH-prees · n.
Regulatory

Mexico's equivalent of the FDA. Stands for Comisión Federal para la Protección contra Riesgos Sanitarios. COFEPRIS licenses Hospital Angeles, the physician team's laboratory, and the regenerative medicine program, and inspects them. Equivalent to the FDA in structure, with different specific rules.

TechnicalFederal regulatory body under the Secretaría de Salud. Operates ISO-9001-aligned inspection programs, NOM-standard biosafety rules (NOM-059, NOM-073, NOM-220), and a cell-therapy register tied to hospital licensure. Member of the PIC/S (Pharmaceutical Inspection Co-operation Scheme).
See also: §2 Why Mexico · §3.5
Cryopreservation
cry-oh-prez-er-VAY-shun · n.
Manufacturing

Freezing cells so they can be stored and shipped. Cells are frozen in a special solution (which keeps ice crystals from forming inside them) at −196 °C in liquid nitrogen. They're thawed within an hour of infusion and tested before going into you.

TechnicalVitrification at < −150 °C in cryoprotectant medium (commonly DMSO + albumin); storage in vapor-phase LN₂. Standard rate-controlled freeze: −1 °C/min through ice-nucleation, then deep storage. Post-thaw viability ≥95% required for release per our SOPs.
Cytokine
SY-toh-kine · n.
Biology

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.

TechnicalLow-MW (8–30 kDa) signaling proteins. MSC-secreted cytokines / soluble factors include TSG-6, IDO, PGE₂, IL-10, HGF, VEGF, FGF-2, operating through paracrine signaling on local immune and parenchymal cells. The cytokine secretome is the mechanism of action for IV-MSC therapy.
E
2 entries · Endotoxin · Exosome
Endotoxin
en-doh-TOK-sin · n.
Manufacturing

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.

TechnicalLipopolysaccharide (LPS) from the outer membrane of gram-negative bacteria. Measured by Limulus amebocyte lysate (LAL) assay. USP <85> threshold for IV cell products: <0.5 EU/mL. Release criterion in our SOP: ≤0.25 EU/mL.
Exosome
EK-soh-some · n.
Biology

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 don't offer them. The biology is real but the products are not the same thing.

Technical30–150 nm extracellular vesicles of endosomal origin, carrying miRNA, mRNA, proteins, and lipids. Released by most cell types including MSCs. Acellular by definition; no live-cell biology, no engraftment. U.S. commercial exosome products are typically MSC-derived and operate under 21 CFR 1271 framing.
F
2 entries · FDA · Flow cytometry
FDA
"Food & Drug Administration"
Regulatory

The U.S. federal regulator for drugs, biologics, and medical devices. Our cell product is not FDA-approved for U.S. import for the indications we treat. That's the legal reason we're in Mexico, not California. The cells themselves are characterized to the same biology standards a U.S. lab would use.

TechnicalU.S. Food and Drug Administration. Regulates HCT/Ps under 21 CFR 1271; cell-therapy biologics under BLA / IND pathways. Allogeneic MSCs for the indications we treat would require IND-stage clinical-trial approval, which the FDA has not granted for these indications.
Flow cytometry
"flow sy-TOM-eh-tree"
Manufacturing

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 "200 million viable cells" number on your CoA comes from this machine.

TechnicalSingle-cell laser-interrogation technique measuring forward / side-scatter (size, granularity) plus multi-channel fluorescence. Used for both cell counting and identity panel (CD73 / CD90 / CD105 +ve, CD34 / CD45 / HLA-DR -ve per ISCT minimum criteria for MSCs).
H
2 entries · HCT/P · Homologous use
HCT/P
"Human Cells, Tissues, and cellular and tissue-based Products"
Regulatory

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 are operating in the §361 tier. Our cells would be §351.

Technical21 CFR 1271. §361 HCT/Ps: minimally manipulated, intended for homologous use, not combined with a drug or device, no systemic effect (or autologous only). Everything outside that envelope is regulated as a biologic drug under §351 with full BLA pathway.
See also: §6.3
Homologous use
huh-MAH-luh-gus · adj.
Regulatory

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.

Technical21 CFR 1271.3(c): "the repair, reconstruction, replacement, or supplementation of a recipient's cells or tissues with an HCT/P that performs the same basic function or functions in the recipient as in the donor." Non-homologous use disqualifies §361 status and triggers §351 biologic-drug requirements.
I
2 entries · IND · Informed consent
IND
"Investigational New Drug"
Regulatory

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. INDs take years and tens of millions of dollars. Most clinical MSC programs in the U.S. are stuck at the IND stage.

Technical21 CFR 312. Required before any clinical investigation in U.S. humans of a drug or biologic not the subject of an approved BLA / NDA. Contains preclinical data, CMC (chemistry / manufacturing / controls), proposed protocol. 30-day FDA review hold before trial may start.
Informed consent
n.
Clinical

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 a 14-page document reviewed with you by a physician (not a coordinator) the day before infusion.

TechnicalPer Mexican federal law NOM-004-SSA3-2012 + WMA Declaration of Helsinki Article 26. Must be obtained in writing, in the patient's primary language, with documented opportunity for questions. For cell therapy: must disclose product type, source, manufacturing standard, known/unknown risks, alternatives, right to withdraw.
K
1 entry · Karyotype
Karyotype
KAR-ee-oh-type · n.
Manufacturing

A photograph of a cell's chromosomes. We karyotype every batch to confirm the cells still have the normal 46 human chromosomes, in the normal arrangement, after manufacturing. A karyotype change would be a stop-the-line event.

TechnicalG-band metaphase analysis of ≥20 mitoses. Confirms 46,XX or 46,XY normal complement; flags translocations, deletions, aneuploidies. ISCT-recommended for cGMP cell-therapy release; required by our SOP at master cell bank and at every working bank derivation.
L
1 entry · LAL assay
LAL assay
"Limulus amebocyte lysate"
Manufacturing

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.

TechnicalUSP <85> / Ph. Eur. 2.6.14. Endotoxin detection via the limulus amebocyte enzyme cascade. Sensitivity to ≤0.005 EU/mL. Three methodologies: gel-clot, turbidimetric, chromogenic. We use chromogenic kinetic for quantitative release.
M
4 entries · MSC · Master cell bank · Minimal manipulation · Mycoplasma
Mesenchymal stromal cell
MSC · n. · "meh-ZEN-kih-mul"
Biology

The 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.

TechnicalISCT 2006 minimum criteria: plastic-adherent under standard culture; expresses CD73, CD90, CD105 and lacks CD45, CD34, CD14/CD11b, CD79α/CD19, HLA-DR; differentiates in vitro into osteoblasts, adipocytes, chondroblasts. UC-MSCs derive from Wharton's jelly of the umbilical cord.
Master cell bank
MCB · n.
Manufacturing

The original frozen "seed" stock of cells, made once from a single donor 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.

TechnicalTier 1 of two-tiered cell-banking system per ICH Q5D. MCB characterization: identity, viability, sterility, mycoplasma, adventitious agents, karyotype, tumorigenicity (in vivo + soft agar), donor eligibility panel. Working cell bank (WCB) derived from MCB; clinical lots manufactured from WCB.
See also: §3.4
Minimal manipulation
n. · FDA term of art
Regulatory

An FDA term meaning "the tissue still does what it did in the donor." Centrifuging blood = minimal. Culturing cells, expanding them, freezing them, and re-thawing 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.

Technical21 CFR 1271.3(f). For structural tissue: processing that does not alter the original relevant characteristics relating to the tissue's utility for reconstruction, repair, or replacement. For cells / nonstructural tissue: processing that does not alter the relevant biological characteristics of cells or tissues. Cell expansion in culture alters proliferative kinetics → not minimal.
Mycoplasma
my-koh-PLAZ-muh · n.
Manufacturing

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.

TechnicalUSP <63> / Ph. Eur. 2.6.7. Detection by qPCR (4-hr turnaround) plus broth/agar culture (28-day confirmation). Common contaminating species: M. orale, M. hyorhinis, A. laidlawii. Filters with 0.22 µm nominal pore size do not exclude mycoplasma, release testing is the only safeguard.
P
5 entries · Paracrine · Passage number · Potency assay · PRP · Pluripotent
Paracrine
PAIR-uh-krin · adj.
Biology

"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.

TechnicalCell-to-cell signaling via secreted soluble factors acting on nearby cells, in contrast to endocrine (systemic) or autocrine (self) signaling. The MSC paracrine secretome includes cytokines, growth factors, chemokines, and extracellular vesicles. The dominant proposed mechanism for IV-MSC therapeutic effect.
Passage number
n. · "P3," "P5"
Manufacturing

How many times the cells have been split and re-plated since the original sample. Each round of expansion = +1 passage. Lower is better. Old, high-passage cells (P10+) start to lose their signaling potency and accumulate chromosomal changes.

TechnicalSub-culture / re-seeding cycle count. Each MSC passage = ~3–4 population doublings. ISCT cautions on senescence-associated phenotype shift beyond P6–P7 (declining secretome potency, telomere shortening, karyotypic drift risk).
See also: §3.4
Potency assay
n.
Manufacturing

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.

TechnicalFunctional bioassay for biologic-product release. For UC-MSCs we use IDO (indoleamine 2,3-dioxygenase) induction in response to IFN-γ stimulation, quantified by kynurenine output. Alternative: T-cell suppression mixed-lymphocyte reaction. Required by FDA for IND-stage cell therapy and by COFEPRIS / EMA equivalents.
PRP
"Platelet-Rich Plasma"
Biology

A concentrated preparation of your own platelets, made by spinning your blood in a centrifuge. PRP is autologous, FDA-tolerated under §361, and commonly used by orthopedists. It is not the same thing as a stem cell therapy, though it is sometimes marketed alongside one.

TechnicalAutologous plasma fraction enriched for platelets via density-gradient centrifugation; typically 3–5× whole-blood platelet concentration. Releases growth factors (PDGF, VEGF, TGF-β) on activation. Operates under 21 CFR 1271 §361 framing in the U.S.
Pluripotent
ploo-RIP-oh-tent · adj.
Biology

"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.

TechnicalCapacity to differentiate into derivatives of all three germ layers (ectoderm, mesoderm, endoderm). Includes hESCs and iPSCs. MSCs are multipotent (mesoderm lineage only). Pluripotent cells form teratomas in immunodeficient mouse models, a property used both as a definitional test and a clinical-safety concern.
See also: §3
R
2 entries · Release testing · RCT
Release testing
n.
Manufacturing

The set of tests every lot of cells must pass before it can be released for human use. We run eight: sterility, mycoplasma, endotoxin, identity, viability, potency, karyotype, trace impurities. Each one has a hard threshold; any single failure discards the lot.

TechnicalcGMP release-specification panel signed by QA director per ICH Q7. Each assay has a defined method (USP / Ph. Eur. / ISO), a defined acceptance criterion, and a signed batch-record entry. The panel and thresholds are negotiated with the regulator at filing.
RCT
"Randomized Controlled Trial"
Clinical

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.

TechnicalProspective interventional study with randomized treatment allocation, ideally double-blinded with placebo control. Phase 2: efficacy signal-seeking, typically 100–300 subjects. Phase 3: confirmatory, typically 500–3,000 subjects. The MSC literature for non-orthopedic indications is dominated by phase 1/2 with limited phase 3 to date.
S
3 entries · Section 361 · Sterility · SVF
Section 361
"§361 HCT/P"
Regulatory

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 have no systemic effect (or be autologous). Most U.S. "stem cell" clinics operate here. Our cells do not qualify and would require §351 biologic-drug approval.

Technical21 CFR 1271 Subpart A, including the four-pronged test at 1271.10. §361 tissues require donor-eligibility and establishment registration but no premarket approval. §351 (biologic drug) requires IND, BLA, and active FDA approval before marketing, the threshold most cell-expansion products fail.
See also: §6.3
Sterility
n.
Manufacturing

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.

TechnicalUSP <71> / Ph. Eur. 2.6.1. Direct-inoculation or membrane-filtration method into FTM (anaerobic) and TSB (aerobic / fungal) media, 14-day incubation at controlled temperature. For short-shelf-life cell products: rapid micro methods (BacT/ALERT, Bactec) supplement the 14-day classical assay.
See also: §3.6
SVF
"Stromal Vascular Fraction"
Biology

A cell mixture obtained by digesting fat tissue. Contains a few MSCs alongside many other cell types. SVF is autologous, minimally-processed, and §361-eligible in the U.S. so many U.S. wellness clinics offer it. It is not the same product as a characterized, expanded UC-MSC infusion.

TechnicalHeterogeneous cell population isolated from adipose tissue via collagenase digestion + centrifugation. Contains adipose-derived stromal cells (ASCs) at ~1–5% of total, plus endothelial, hematopoietic, smooth-muscle, and pericyte populations. Operates under 21 CFR §361 framing when minimally processed and used homologously.
See also: §6.3
T
2 entries · Trace impurities · Tumorigenicity
Trace impurities
n.
Manufacturing

Residual amounts of reagents used during cell manufacturing (culture-medium components, growth factors, the cryoprotectant DMSO) that have to be measured at release 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.

TechnicalProcess residuals including DMSO, bovine serum albumin (or platelet lysate substitute), antibiotics if used, growth-factor supplements, collagenase, trypsin. ICH Q3A/B-style approach: each residual quantified, thresholds set against tolerable daily intake. DMSO <1 g/dose typical IV cell-therapy limit.
See also: §3.6
Tumorigenicity
too-mor-i-jen-IS-i-tee · n.
ClinicalBiology

The capacity of a cell to form a tumor. MSCs are not tumorigenic in any of the published data we work from the global registry of allogeneic MSC infusions (now ~1.5M doses) shows no cell-derived tumor formation. We test for it anyway at the master cell bank stage because we'd rather over-test than miss it.

TechnicalCapacity to form neoplasm in vivo, assessed by SCID-mouse subcutaneous injection (6-month follow-up) and soft-agar colony formation in vitro. Required for MCB characterization. Distinct from pluripotent-cell teratoma risk; MSC tumorigenicity in clinical data is null to date across published cohorts.
U
1 entry · UC-MSC
UC-MSC
"Umbilical Cord MSC"
Biology

A mesenchymal stromal cell isolated from the umbilical cord, specifically from Wharton's jelly, the gel-like tissue inside the cord. This is the source of our cells. Cords are donated after term healthy births, with consent from the mother, and would otherwise be discarded.

TechnicalUmbilical-cord-derived MSCs. Higher proliferative capacity than adult bone-marrow-derived MSCs (BM-MSCs); longer-lived in culture before senescence; lower donor-to-donor variability; non-invasive sourcing. Standard isolation protocol: explant or enzymatic digestion of Wharton's jelly, plastic adherence, characterization to ISCT criteria.
V
1 entry · Viability
Viability
n.
Manufacturing

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. Live cells take up a dye called 7-AAD; dead cells let it cross the membrane. The instrument counts both.

TechnicalLive/dead cell ratio determined by membrane-integrity exclusion stain. 7-AAD (7-amino-actinomycin D) for flow cytometry: enters cells with compromised plasma membrane only. Alternative: trypan blue exclusion under hemocytometer. Our release: ≥95% viability post-thaw at time of infusion.
W
1 entry · Wharton's jelly
Wharton's jelly
n. · proper noun
Biology

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.

TechnicalMucous connective tissue of the umbilical cord, between the amniotic epithelium and the cord vessels. Rich in hyaluronic-acid–laden mesenchymal cells. Preferred source for UC-MSC isolation over cord blood (CB-MSCs, lower yield) or cord lining (CL-MSCs, epithelial-leaning).