The science of stem cells, plainly.
What mesenchymal stromal cells, Muse cells and exosomes are, what the research shows so far, and the questions worth asking before you decide.
The basics
Three terms you will hear.
Mesenchymal stromal cells (MSCs)
Cells found in tissues such as umbilical cord, bone marrow and fat. In the laboratory they can become bone, cartilage or fat cells, and researchers study the signals they release, which influence inflammation and the surrounding tissue.
Muse cells
A small, stress-tolerant subgroup identified within mesenchymal cell populations by a surface marker called SSEA-3. They are an active area of research and far less studied than MSCs as a whole.
Exosomes and secretome
Tiny vesicles and proteins that cells release to communicate. Exosome products contain no cells. There are currently no FDA-approved exosome products.
Where the cells come from
From donation to the clinic.
Every product supplied through RegenerateLife follows the same documented path.
- Stage 1
Donation
Umbilical cord tissue donated after healthy, full-term births, with the parent’s informed consent.
- Stage 2
Screening
Donor screening and infectious-disease testing before any tissue is processed.
- Stage 3
Processing
Processed and released by the laboratory against a written specification.
- Stage 4
Cryopreservation
Frozen for storage, with a Certificate of Analysis for each lot.
- Stage 5
Cold chain
Shipped frozen to the licensed clinic, with temperature records.
- Stage 6
At the clinic
Stored, thawed and prepared by the clinic, whose clinician decides how and whether it is used.
How they are thought to work
Signals, not magic.
Researchers are studying several ways MSCs may act: by releasing signaling molecules, by influencing the immune response, and by supporting the local tissue environment.
These are mechanisms described in published research. They are not a promise of results, and how much they matter for any one person is exactly what is still being studied.
What the research says
- MSCs have been studied in a large number of clinical trials worldwide, for many different goals.
- Product quality can be measured and documented: identity, cell count, sterility and endotoxin, lot by lot.
- Side effects and risks exist and should be explained to you by the clinic before any decision.
What it doesn’t say yet
- That a cell therapy will work for your particular goal. Well-controlled trials disagree, and results vary.
- Which source, dose or route is best for a given purpose.
- How long any effect lasts, or whether repeat sessions help.
Regulation in the U.S.
The regulatory status, plainly.
In the United States, cell and tissue products that are processed beyond minimal manipulation, or used for a purpose other than their natural one, are regulated by the FDA as biological products that require approval. The FDA has approved very few cell therapies, each for specific uses.
Many clinics offer cell and exosome products that are not FDA-approved. Federal rules apply everywhere, and some states have passed laws of their own. Ask any clinic about the regulatory status of what it offers, and whether it is part of a registered clinical trial.
Take this with you
Ten questions to ask any clinic.
A good clinic will be glad you asked. Write the answers down.
- Who will examine me, and what is their license?
- Who is the clinic’s medical director?
- Exactly which product will be used, and which laboratory made it?
- Can I see the Certificate of Analysis for the lot?
- What is the regulatory status of this product, and is it part of a registered clinical trial?
- What are the risks and side effects, and what happens if something goes wrong?
- What is the total price, in writing, and what does it include?
- What follow-up will I get, and who do I call afterwards?
- How is the product stored and thawed before it is used?
- Will you report an adverse reaction, and to whom?
This page is general education, not medical advice. Talk to a licensed clinician about your own situation.
Still have questions?
A care navigator can walk you through any of this, for free.