How Does Stem Cell Therapy Work?

Stem cell therapy generally works in three steps. Providers collect cells from a donor source, often bone marrow, fat tissue, or umbilical cord tissue.

They process the cells in a lab or at the point of care.

Then they introduce the cells into the body, usually near an area of injury or degeneration, where the cells may help support the body's own repair processes.

It's a promising area of medicine. But the science is still catching up to the marketing. Here's a plain-English look at how the process actually works, step by step.

What Is Stem Cell Therapy?

Stem cells are the body's raw material. They are cells that have the potential to develop into many different cell types.

In regenerative medicine, practitioners use these cells with the goal of supporting the body's natural repair mechanisms. This is particularly true in areas affected by wear, injury, or inflammation (Mayo Clinic, n.d.-b).

It's important to be upfront: most stem cell and exosome therapies offered outside of FDA-approved clinical trials are considered investigational.

They are not FDA-approved to cure, treat, or prevent any specific disease (U.S. Food and Drug Administration, 2021).

Instead, these therapies are being studied, and some patients report improvements in comfort or function. Individual results vary, and no legitimate provider should promise a guaranteed outcome.

The Basic Steps: How Stem Cell Therapy Works

While protocols vary by clinic and by the type of cells used, most stem cell therapies follow a similar general sequence:

• Consultation and evaluation. A licensed provider reviews your health history and discusses whether you may be a reasonable candidate for a given approach.
• Collection, if using your own cells. Cells may be collected from your own bone marrow or adipose (fat) tissue through a minimally invasive procedure, or sourced from donor tissue such as umbilical cord tissue, depending on the therapy.
• Processing. The collected material is processed, often concentrated or isolated, to prepare it for administration.
• Administration. The prepared cells are introduced into the body, commonly through injection into or near the area of concern, or intravenously depending on the goal of treatment.
• Follow-up. Patients are typically monitored afterward, and many providers recommend follow-up visits to track how the patient is responding over time.

Where Do the Cells Come From?

There are a few common sources used in regenerative medicine today.

Autologous Sources

Autologous sources use your own tissue, most often bone marrow or fat. These are collected during the same visit as your treatment.

Allogeneic Sources

Allogeneic sources come from donor tissue, such as umbilical cord tissue donated after healthy, consented births. This tissue is screened and processed under laboratory standards before use (Jin et al., 2013).

Each source has different handling requirements. The right choice, if any, depends on your specific situation and what a licensed physician recommends after evaluating you.

What Happens During and After Treatment

Most stem cell procedures are performed on an outpatient basis. Collection, if applicable, and administration can often be completed within a few hours.

Many patients describe the experience as similar to other injection-based procedures. Mild soreness at injection sites is a commonly reported, temporary effect.

Recovery expectations vary widely depending on the therapy, the area treated, and the individual. Some patients report noticing changes over weeks to months. Others may not notice a meaningful difference.

Because this field is still developing, it's wise to set realistic expectations. Ask your provider what published evidence exists for the specific therapy you're considering.

What the Research Says (and Doesn't Say Yet)

Regenerative medicine is an active and fast-moving area of research. Clinical trials are underway across many specialties, including orthopedics and sports medicine, looking at how stem cells and related products like exosomes may support tissue health (Mayo Clinic, n.d.-a).

However, the majority of these applications remain investigational. The FDA has approved only a limited number of specific stem cell products for specific conditions, mainly related to blood-forming stem cell transplants (U.S. Food and Drug Administration, 2021).

That means when you see a clinic offering stem cell therapy for joint pain, general wellness, or other common concerns, it's almost always outside of FDA-approved indications.

That doesn't mean it's not worth discussing with a physician. Many patients do explore these options. But it does mean you should ask direct questions about the evidence, the cell source, and the provider's experience before moving forward (The Pew Charitable Trusts, 2021).

Is Stem Cell Therapy Right for You?

Deciding whether to explore stem cell therapy is a personal decision. It should be made with a licensed physician who understands your full health picture.

A good consultation should cover:

• Your goals
• Your medical history
• The specific therapy being proposed
• Its cell source
• What current research does and doesn't support

It should never rely on high-pressure sales tactics or guarantees of a cure.

Frequently Asked Questions

Is stem cell therapy FDA-approved?

Most stem cell therapies offered for orthopedic or wellness purposes are not FDA-approved and are considered investigational. A small number of specific stem cell products are FDA-approved for specific blood-related conditions.

Does stem cell therapy hurt?

Discomfort varies by procedure. Collection and injection sites may be sore for a short time afterward, similar to other minor outpatient procedures.

How long does it take to notice a difference?

This varies significantly by person and by therapy. Some patients report changes over weeks to months; others may not notice a meaningful change. There is no guaranteed timeline or outcome.

Is stem cell therapy safe?

As with any medical procedure, there are potential risks. Safety depends heavily on the source of the cells, the clinical setting, and the provider's qualifications. Discuss risks and benefits with a licensed physician before proceeding.

How do I know if I'm a good candidate?

The only way to know is through a one-on-one evaluation with a licensed physician who can review your health history and goals in detail.

Ready to Learn More?

If you're curious whether regenerative medicine may be worth discussing for your situation, consider scheduling a consultation with a licensed physician to review your options and ask questions directly.

References

Jin, H. J., Bae, Y. K., Kim, M., Kwon, S.-J., Jeon, H. B., Choi, S. J., Kim, S. W., Yang, Y. S., Oh, W., & Chang, J. W. (2013).

Comparative analysis of human mesenchymal stem cells from bone marrow, adipose tissue, and umbilical cord blood as sources of cell therapy. International Journal of Molecular Sciences, 14(9), 17986–18001. https://doi.org/10.3390/ijms140917986

Mayo Clinic. (n.d.-a). Stem cell therapy clinical trials. Mayo Clinic Research. https://www.mayo.edu/research/clinical-trials/tests-procedures/stem-cell-therapy

Mayo Clinic. (n.d.-b). Stem cells: What they are and what they do. https://www.mayoclinic.org/tests-procedures/bone-marrow-transplant/in-depth/stem-cells/art-20048117

The Pew Charitable Trusts. (2021, June 1). Harms linked to unapproved stem cell interventions highlight need for greater FDA enforcement. https://www.pew.org/en/research-and-analysis/issue-briefs/2021/06/harms-linked-to-unapproved-stem-cell-interventions-highlight-need-for-greater-fda-enforcement

U.S. Food and Drug Administration. (2021, June 3). Important patient and consumer information about regenerative medicine therapies. U.S. Department of Health and Human Services. https://www.fda.gov/vaccines-blood-biologics/consumers-biologics/important-patient-and-consumer-information-about-regenerative-medicine-therapies

This article is for educational purposes only and is not medical advice.

Stem cell and exosome therapies discussed here are largely investigational. The FDA has not approved them for any disease. Individual results vary.

Please consult a licensed physician before making any medical decisions. Medically reviewed by Kenny Chantasi, DO.

Related reading

• Do Stem Cell Injections Work?
• How Long Is Recovery After Stem Cell Therapy?
• Stem Cells for Hearing Loss: What Research Shows

More questions answered on the PrimeCell patient blog, or see frequently asked questions.

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