Where Do the Stem Cells Used in Therapy Come From?

What This Means

"Stem cell therapy" is not one product. It is a category of procedures that differ by where the cells come from, how they are processed, and what a clinic is legally permitted to offer. The two broad sourcing categories are autologous — cells collected from the same patient who will receive them, typically drawn from bone marrow in the hip (pelvis) or from fat tissue through a small liposuction-style collection — and allogeneic — cells collected from a donor, most often from umbilical cord tissue (including Wharton's jelly) or placental tissue after a consented, healthy birth (Hass et al., 2011).

Sourcing also determines the regulatory category a product falls into. Under federal guidance, a cell or tissue product can generally be handled with less oversight if it is only "minimally manipulated" from its original state and used for a "homologous" purpose — meaning it performs the same basic function in the recipient that it performed in the donor (Food and Drug Administration, Center for Biologics Evaluation and Research [CBER], Center for Devices and Radiological Health, & Office of Combination Products, 2020). Once a product is processed beyond that — expanded in a lab, combined with other substances, or used for a different purpose than its original one — it is regulated as a drug or biologic, which requires its own FDA approval pathway. Almost no orthobiologic stem cell product used for joint, tendon, or spine concerns has gone through that pathway.

Candidacy

Candidacy is not something a patient selects by picking a source. It is determined by a physician after reviewing the specific problem being addressed, prior treatment history, imaging, medication use (including blood thinners), and any active infection or malignancy history. Some sourcing options are ruled out for reasons unrelated to personal preference — for example, a patient on certain anticoagulants may not be a candidate for a bone marrow aspiration at all, regardless of how well they might otherwise respond to a regenerative approach.

A patient who specifically wants to avoid a second collection site (as with autologous sourcing) or who wants to avoid donor-tissue products entirely (as with allogeneic sourcing) should say so during the evaluation — but the final recommendation is a clinical one, not a menu choice.

Clinical Evaluation

A proper evaluation before any regenerative procedure includes a musculoskeletal and neurological exam, a review of prior imaging (X-ray, MRI, or ultrasound), and a conversation about what has already been tried — physical therapy, medications, injections, or surgery. Only after that does a physician discuss whether an autologous or allogeneic source is being considered, and why. That explanation should cover the collection method, expected processing time, and how the product will be handled between collection and administration.

Patients should ask directly where the product comes from, whether it is processed in-house or by a third-party lab, and whether that lab is registered with the FDA as a tissue establishment. A clinic unwilling or unable to answer those questions clearly is a reason for caution.

Available Options

Conventional, mainstream options for musculoskeletal pain remain the first line for most patients: physical therapy, activity modification, oral or topical anti-inflammatory medication, corticosteroid injections, and, when appropriate, surgical referral. Platelet-rich plasma (PRP) is a related but distinct option — it concentrates a patient's own platelets and growth factors rather than stem cells, and it has its own separate evidence base.

Among regenerative options specifically, the sourcing categories break down as: autologous bone-marrow-derived products (often called bone marrow aspirate concentrate, or BMAC), autologous adipose-derived products, and allogeneic cord- or placental-tissue-derived products. All of these are considered investigational for orthopedic and musculoskeletal use outside of a registered clinical trial (Food and Drug Administration, n.d.).

Benefits, Limitations and Risks

Autologous sourcing avoids the immune and disease-transmission concerns that come with using another person's tissue, since the patient receives their own cells back. Its main drawbacks are a second procedure site (the bone marrow or fat collection site, which carries its own soreness and small infection or bleeding risk) and processing time, and cell quality and quantity can vary by age and health status (Hass et al., 2011).

Allogeneic sourcing avoids a second collection site and can be prepared in advance for same-day use, but it depends entirely on the sourcing lab's screening, processing, and quality controls (Li et al., 2021). This is also where the FDA has documented the most serious problems: the agency has linked unapproved, poorly screened umbilical-cord and exosome products to serious infections, including bloodstream infections requiring hospitalization, in patients who received them outside of any FDA-authorized study (Food and Drug Administration, n.d.). No source is risk-free, and no regenerative product of any sourcing type is guaranteed to produce a particular outcome.

What the Evidence Shows

Laboratory research does show real biological differences between sources. Bone-marrow-, adipose-, and umbilical-cord-derived mesenchymal stem cells differ in how quickly they multiply, how long they retain their regenerative capacity, and how they interact with the immune system (Hass et al., 2011). Comparative reviews of allogeneic versus autologous approaches likewise describe real, measurable trade-offs in availability, immune interaction, and manufacturing scale (Li et al., 2021).

What the evidence does not yet establish is that one source produces superior long-term pain relief or functional outcomes over another in human musculoskeletal patients. Large, high-quality randomized trials comparing sourcing options head-to-head for joint or spine conditions are limited. The FDA has not approved a stem cell product from any source — autologous or allogeneic — for orthopedic or musculoskeletal use; the only FDA-approved stem cell products are cord-blood-derived blood-forming stem cells used for specific blood disorders, an entirely different application (Food and Drug Administration, n.d.).

Recovery and Next Steps

Recovery expectations depend partly on sourcing. A bone marrow aspiration adds soreness at the hip collection site for several days on top of the injection site itself; an adipose collection adds mild bruising and soreness similar to a small liposuction. Allogeneic procedures involve only the injection site, since there is no collection procedure for the patient. In every case, a physician should provide specific aftercare instructions and a realistic timeline before the procedure, not after.

Orlando Considerations

Florida has its own statute governing how physicians may offer stem cell and other regenerative products, including specific informed-consent and disclosure requirements (Fla. Stat. § 458.3245, 2025). An Orlando-area patient evaluating a clinic should ask whether the practice's regenerative offerings comply with that statute, whether the physician performing the procedure is the one who evaluated the patient, and whether any product used comes from a facility registered with the FDA. These are reasonable, answerable questions, and a physician-led practice should be able to walk through them without hesitation.

Frequently Asked Questions

Is donor-derived (allogeneic) stem cell material safer than using my own cells?

Not automatically. Autologous sourcing avoids donor-related infection and immune concerns, while allogeneic sourcing avoids a second collection site. Each carries a different risk profile, and the FDA's most serious documented safety actions have involved poorly screened donor-tissue products (Food and Drug Administration, n.d.).

Can I just request whichever source I prefer?

You can express a preference, but the physician's evaluation — your health history, medications, and the specific area being addressed — determines what is medically appropriate and legally offered.

Is umbilical cord or Wharton's jelly stem cell material FDA-approved?

No. No umbilical-cord- or placental-derived stem cell product is FDA-approved for orthopedic, aesthetic, or general regenerative use. The only FDA-approved stem cell products are cord-blood-derived blood-forming cells used for specific blood disorders (Food and Drug Administration, n.d.).

Does the source of the cells change how much a procedure costs?

Often, yes. Autologous procedures typically involve an additional collection step that affects pricing, while allogeneic products are priced based on the supplying lab. Ask for an itemized explanation of what is included before scheduling.

Is bone marrow aspiration painful?

Most patients describe pressure or brief discomfort during collection, usually managed with local anesthetic, followed by soreness at the site for a few days. A physician can describe what to expect for a specific case.

This article is for general education and does not replace a medical evaluation. Regenerative products discussed here, including stem cell and related orthobiologic products, are investigational for musculoskeletal use outside of FDA-approved clinical trials and are not FDA-approved to diagnose, cure, mitigate, treat, or prevent any disease. Individual results vary. Candidacy and treatment options are discussed only after a medical evaluation.

Medically reviewed by Kenny Chantasi, DO.

References

Cleveland Clinic. (2023). Bone marrow aspirate concentrate (BMAC) for injuries or arthritis. https://my.clevelandclinic.org/health/procedures/bone-marrow-concentrate-bmc

Fla. Stat. § 458.3245 (2025).

Food and Drug Administration. (n.d.). Consumer alert on regenerative medicine products including stem cells and exosomes. U.S. Department of Health and Human Services. https://www.fda.gov/vaccines-blood-biologics/consumers-biologics/consumer-alert-regenerative-medicine-products-including-stem-cells-and-exosomes

Food and Drug Administration, Center for Biologics Evaluation and Research, Center for Devices and Radiological Health, & Office of Combination Products. (2020). Regulatory considerations for human cells, tissues, and cellular and tissue-based products: Minimal manipulation and homologous use: Guidance for industry and Food and Drug Administration staff. https://www.fda.gov/media/109176/download

Hass, R., Kasper, C., Böhm, S., & Jacobs, R. (2011). Isolation, expansion and characterisation of mesenchymal stem cells from human bone marrow, adipose tissue, umbilical cord blood and matrix: A comparative study. Cell Communication and Signaling, 9, Article 12. https://doi.org/10.1186/1478-811X-9-12

Li, C., Zhao, H., Cheng, L., & Wang, B. (2021). Allogeneic vs. autologous mesenchymal stem/stromal cells in their medication practice. Cell & Bioscience, 11, Article 187. https://doi.org/10.1186/s13578-021-00698-y

Last medically reviewed: September 21, 2026

Related reading

• How Does Stem Cell Therapy Work?
• Who Should Not Get Stem Cell Therapy?
• What Are the Side Effects of Stem Cell Therapy?
• Does Insurance Pay for Stem Cell Injections? 2026 Guide

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

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PrimeCell is a physician-led practice in Orlando. Candidacy for any procedure is determined at an in-person evaluation.