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Stem cell therapy vs. cellular therapy.
Two names that often describe the same procedure, and sometimes describe very different ones. What the words mean, and why the distinction matters when you're comparing clinics.
Direct answer
Most of the time they describe the same procedure. "Stem cell therapy" is the popular name; "cellular therapy" is the accurate one. The complication is that the popular name is also used to sell procedures that are not the same thing at all, donor, umbilical cord, or culture-expanded cells, and that difference is the one the FDA cares about. What we perform is cellular therapy: your own bone marrow, concentrated in our lab, returned to you the same day.
01 · Two names
Why there are two names for one procedure.
The popular name arrived first. In the early 1990s, researchers isolated plastic-adherent cells from bone marrow that could be pushed toward bone, cartilage, and fat lineages in a culture dish, and called them mesenchymal stem cells. The word "stem" carried an implicit promise: that these cells would grow into new tissue inside the body the way they did in a dish.
Two decades of clinical work has not borne that out. The dominant effect of these cells in the body is signaling, not replacement, and in 2006 the International Society for Cellular Therapy proposed replacing "stem" with stromal in the literature.1 Most peer-reviewed work has followed. We cover that shift in detail in "Stromal" vs. "stem" cells.
"Cellular therapy" is the clinical umbrella term. It describes what is actually delivered: a preparation of cells, taken from you, concentrated, and placed where it is needed. It makes no claim about which cell in that population is doing the work, and it does not promise that anything regrows.
In plain language
"Stem cell therapy" names a hoped-for mechanism. "Cellular therapy" names what is in the syringe. The second is the one we can stand behind.
02 · Our term
What cellular therapy means in this clinic.
When we say cellular therapy, we mean one specific thing: autologous bone marrow aspirate concentrate, usually shortened to BMAC.
The material is yours. Bone marrow is aspirated from your iliac crest under image guidance. Nothing comes from a donor, a cord blood bank, or a placental or amniotic product.
The marrow is concentrated in our on-site lab. It is not expanded in culture, not combined with another article, and not altered in a way that changes its biological characteristics.
Aspiration, processing, and delivery happen in a single visit, within one procedural window. This is what places the procedure inside the "same surgical procedure" exception at 21 CFR 1271.15(b).2
BMAC contains mesenchymal stromal cells among many other cell types. It is not a purified or isolated stem-cell product, and we do not describe it as one.
The term is deliberately modest. It describes the procedure without asserting a mechanism the evidence does not support.
03 · The popular term
What "stem cell therapy" usually means.
This is where the phrase becomes a problem. At least four genuinely different things are sold under one name, and they carry very different regulatory and clinical profiles:
Your own marrow or adipose tissue, processed and returned in one visit. Legal as a clinical procedure under the HCT/P framework. This is what we do, and it is what most patients are picturing.
Umbilical cord, placental, or amniotic products. These almost always cross into FDA drug-product territory, and most are not approved for the indications they are marketed for. The bulk of FDA enforcement in this space targets this category.
Cells grown in a laboratory over days or weeks to increase their number. Expansion takes the product out of the same-day exception and into drug regulation.
Bone marrow and cord blood transplants for leukemias, lymphomas, and inherited immune disorders. Genuinely FDA-approved, decades old, and standard of care, but it is transplant medicine for blood disease, not a treatment for a painful knee.
Regulatory framing, Boulder Biologics
"The FDA has raised particular concern regarding allogeneic (donor-derived) stem cell products, including umbilical cord, placental, and amniotic products, marketed outside of approved clinical trials. This distinction is important, as FDA enforcement actions have primarily targeted unapproved donor-derived products marketed without appropriate authorization."
A patient reading two clinic websites can see the same three words on both and be looking at two completely different procedures. That is the practical cost of the popular name.
04 · The comparison
Where the terms overlap, and where they don't.
When a clinic offering autologous same-day treatment says "stem cell therapy," it usually means the same procedure we call cellular therapy. The words diverge in three places:
"Cellular therapy," as we use it, is always your own tissue. "Stem cell therapy" says nothing about where the cells came from. The word carries no information about the thing that matters most.
"Stem cell" implies the cells become new tissue. The evidence points to signaling, immune modulation, and support of your own repair processes instead. "Cellular therapy" leaves the question open, which is where the science currently sits.
Same-day autologous procedures operate as clinical procedures. Donor-derived and culture-expanded products are regulated as drugs and mostly lack approval. Both get called "stem cell therapy" in marketing.
The useful question
Not "is this stem cell therapy?" but "whose cells are these, and what was done to them between the draw and the injection?" Those two answers tell you nearly everything the label does not.
05 · Our usage
Which term we use, and why.
We use both, in defined places, and we would rather state the rule plainly than have you infer it:
- In scientific and clinical writing, we say mesenchymal stromal cells, the ISCT-aligned term.
- In conversation with patients, we sometimes say "stem cells" because it is the familiar word and too much new vocabulary at once is not useful. Where it is appropriate, we explain the stromal-versus-stem distinction.
- We describe the clinical effect in functional terms, cell-to-cell signaling, immune modulation, support for your own tissue's repair, not regeneration, replacement, or regrowth.
- In page titles and headings we sometimes include "(stem cells)" parenthetically, so that patients searching the popular term reach the right page. The body of the page uses the accurate term.
Boulder Biologics
"At Boulder Biologics, we use autologous stem cells only."
"Consistent with FDA guidance, we avoid unsupported claims regarding 'stem cell' replacement or regeneration."
That last practice is the reason this page exists. Using the popular phrase to be findable, while using the accurate one to describe what actually happens, is a defensible position only if we say out loud that we are doing it.
06 · For patients
What to ask any clinic, whichever name they use.
The label on the website tells you very little. These four questions tell you almost everything:
- Whose cells are these? Mine, or a donor's? If a donor's, from what tissue?
- What happens between the draw and the injection? Concentrated the same day, or expanded in a lab over days or weeks?
- What is the regulatory status of this specific procedure for my specific condition? A clear answer here is a good sign, including when the answer is "this is investigational."
- What is this expected to do? Claims of regrowth, reversal, or cure are not supported by the current evidence for these procedures.
These are reasonable questions to ask us, too. If a consultation cannot answer them plainly, that is worth knowing before anything else is discussed.
Where this fits
Whether a given procedure makes sense for your history, your imaging, and your goals is a conversation, not a web page. A consultation is where we work that out together.
07 · Common questions
Frequently asked.
So is what you do "stem cell therapy" or not? +
If you mean the procedure most patients picture, your own marrow, concentrated and placed under image guidance, then yes, that is what we do, and many clinics call it stem cell therapy. We call it cellular therapy because bone marrow concentrate is a mixed cell population rather than an isolated stem-cell product, and because the name should not imply a mechanism the evidence does not support.
Is cellular therapy just a softer way of saying the same thing? +
It is a more precise way of saying it. "Cellular therapy" describes what is delivered without asserting what the cells do once they are there. That is not softening the claim, it is declining to make a claim the data do not yet support.
Does the difference in wording change what I actually receive? +
Between our language and another clinic offering the same autologous same-day procedure, no. Between autologous cellular therapy and a donor-derived or culture-expanded product marketed under the same phrase, yes, substantially, in source, in processing, and in regulatory status.
Why not just use the popular term everywhere, since that's what people search for? +
Because the terms are not interchangeable in the way the search volume implies, and using the popular one throughout would suggest we offer something we do not. We use it in titles and headings so patients can find the page, and the accurate term in the body so the page describes the actual procedure. Section 05 above states that practice explicitly.
Is any of this FDA-approved? +
No cellular therapy is FDA-approved for orthopedic or systemic conditions, under either name. Certain hematopoietic stem cell transplants and engineered cell products are approved, for blood and immune disorders. Our FDA-approval explainer covers the distinction in full.
References
Sources cited.
- Dominici M, et al. Minimal criteria for defining multipotent mesenchymal stromal cells. The International Society for Cellular Therapy position statement. Cytotherapy. 2006;8(4):315–317.
- U.S. Food and Drug Administration. Same surgical procedure exception under 21 CFR 1271.15(b): questions and answers regarding the scope of the exception. Guidance for Industry, November 2017.
- Caplan AI. Mesenchymal stem cells: time to change the name! Stem Cells Transl Med. 2017;6(6):1445–1451.
- 21 CFR Part 1271, Human Cells, Tissues, and Cellular and Tissue-Based Products. Electronic Code of Federal Regulations.
- U.S. Food and Drug Administration. Important Patient and Consumer Information About Regenerative Medicine Therapies.
- U.S. Food and Drug Administration. Approved Cellular and Gene Therapy Products. Center for Biologics Evaluation and Research.
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