What Is Regenerative Medicine Used For?

Regenerative medicine is used to try to do one of three things with damaged tissue:

• Repair it.
• Restore it.
• Replace it.

Today it falls into two very different buckets.

The first is a narrow set of FDA-approved cord-blood-derived stem cell products. They are used for certain blood cancers and immune disorders.

The second is a much larger, mostly investigational category. It includes PRP, mesenchymal stem cell injections, and exosome products. These are marketed for the following (U.S. Food and Drug Administration, 2020; Mayo Clinic, n.d.):

• Orthopedic pain.
• Sports injuries.
• Other chronic conditions.

The bucket a product falls into changes what it can legally claim to do. It also changes whether strong evidence backs it. So it's worth knowing the difference before you consider treatment.

What This Means

In plain terms, "regenerative medicine" is an umbrella term. It is not one specific procedure.

Only one group of regenerative products is currently FDA-approved for use in the United States. These are blood-forming stem cells (hematopoietic progenitor cells) derived from umbilical cord blood. They are approved specifically for disorders that affect blood production (U.S. Food and Drug Administration, 2020).

Everything else marketed under the regenerative medicine umbrella today falls outside that list. That includes:

• PRP for joint pain.
• Mesenchymal stem cell injections for orthopedic conditions.
• Exosome products for skin or hair.
• Investigational research into neurological or cardiac disease.

Each is either being studied in clinical trials, or offered outside FDA approval as an investigational therapy.

Candidacy

Regenerative medicine is most often considered by patients with chronic joint pain, tendon or ligament injuries, or osteoarthritis. These patients have tried more conservative care without lasting relief (Goulian et al., 2025). Those usually include:

• Physical therapy.
• Anti-inflammatory medication.
• Corticosteroid injections.

It is not a fit for everyone.

Patients are typically poor candidates if they have:

• Active infections.
• Certain cancers.
• Uncontrolled autoimmune disease.
• Bleeding disorders.

Pregnant patients are generally excluded. Candidacy is not universal. A thorough medical evaluation is the right starting point before any responsible recommendation. A marketing brochure is not.

Clinical Evaluation

A reasonable clinical work-up before regenerative medicine includes:

• A detailed history of the injury or condition.
• A physical exam.
• Often imaging such as X-ray, ultrasound, or MRI, to confirm the diagnosis.

This also helps rule out conditions that regenerative injections would not help. A full-thickness tendon tear may need a different approach entirely. So may advanced bone-on-bone arthritis.

Bloodwork may be ordered to screen for:

• Infection.
• Clotting problems.
• Autoimmune markers.

A licensed provider should also review your medication list. Blood thinners and some anti-inflammatories can affect candidacy or timing.

Say a clinic offers to treat you the same day you walk in, without imaging or labs. That's worth questioning.

Available Options

Regenerative medicine sits alongside conventional care. It is not a substitute for it.

Mainstream options for chronic joint and soft-tissue pain include:

• Physical therapy.
• Oral or topical anti-inflammatory medication.
• Corticosteroid injections.
• Hyaluronic acid ("gel") injections.
• Bracing.
• Weight management.

When conservative measures fail, surgical options such as arthroscopy or joint replacement may be considered.

Within regenerative medicine itself, patients usually encounter three categories:

• PRP (concentrated platelets from your own blood).
• Mesenchymal stem cell injections (from bone marrow or adipose tissue).
• Exosome products (cell-derived signaling particles).

A good provider will walk you through where each option fits next to conventional alternatives. A good provider will not present any of them as a universal replacement for standard care.

Benefits, Limitations & Risks

Benefits

Some patients report reduced pain and better function after PRP or stem cell injections for orthopedic conditions.

Researchers are actively studying these approaches. Recent literature identifies mesenchymal stem cell therapy as showing meaningful promise. That promise is for pain reduction, in some studies (Goulian et al., 2025).

Limitations and risks

Real limitations apply:

• Response varies a lot from person to person.
• Results are not guaranteed.
• Effects, when present, may be temporary.

The evidence base is still developing. That is especially true for uses outside orthopedics, such as neurological, cardiac, or autoimmune conditions.

Risks include injection-site pain, swelling, and infection. With unapproved or poorly sourced cell products, more serious complications are possible. The FDA has received reports of the following, linked to unapproved regenerative products:

• Tumor formation.
• Infections.
• Blindness.

What the Evidence Shows

What's established

Current evidence supports that PRP and mesenchymal stem cell injections are generally well tolerated. That holds when they are properly sourced and given. A growing body of orthopedic literature links MSC therapy with pain reduction. That is in some patient groups (Goulian et al., 2025).

What evidence does not establish

The evidence does not yet establish:

• Long-term durability of results.
• Optimal dosing and cell counts.
• Clear superiority over conventional treatment for most conditions.

Researchers and health-economics reviewers have specifically flagged two ongoing challenges for the field. They are the lack of long-term outcomes data and the lack of pricing transparency (Qiu et al., 2022).

In plain terms: there's real research interest and some encouraging orthopedic data. But take a claim that regenerative medicine makes a condition go away. For most uses, the current evidence does not support that. And no clinic should present it that way.

Recovery / Next Steps

Recovery from a regenerative medicine injection is usually short. Most patients have mild soreness or swelling at the injection site for a few days. Most can resume light activity within 24–72 hours.

A gradual return to full activity usually follows, over one to a few weeks. The exact time depends on the joint or tissue treated and the protocol used.

Response is gradual. So a provider will commonly schedule a follow-up visit, at several weeks to a few months. That visit assesses progress before deciding whether additional treatment is warranted.

Orlando Considerations

Florida law shapes how stem cell therapy can be marketed in Orlando. It also shapes how that therapy is delivered.

Under Florida Statutes . 458.3245, a physician may perform stem cell therapy that isn't FDA-approved. That is allowed only for these indications:

• Orthopedic.
• Wound care.
• Pain management.

The physician must source cells from FDA-registered and accredited facilities. The physician must also give patients a specific written notice. That notice discloses that the therapy has not been FDA-approved. A signed informed-consent form is required before treatment (Florida Legislature, 2025).

Any Orlando clinic offering stem cell therapy should be able to show you two things. Those are the consent process and the disclosure. They should show them without hesitation. If they can't, that's a red flag.

Frequently Asked Questions

What conditions is regenerative medicine actually used for today?

Most real-world use is orthopedic. That means joint pain, tendon and ligament injuries, and osteoarthritis. The only FDA-approved use is for certain blood and immune disorders, using cord-blood-derived stem cells. Other applications remain investigational.

Is regenerative medicine FDA-approved?

Only a narrow category is: hematopoietic stem cell products derived from umbilical cord blood. Those are approved for specific blood-related conditions. PRP, mesenchymal stem cell injections, and exosome products are not FDA-approved. That applies to orthopedic, aesthetic, and other purposes. They are considered investigational.

Can regenerative medicine be used for anti-aging or cosmetic purposes?

Some clinics market exosome and stem cell products for skin and hair. But these uses are not FDA-approved. The evidence is limited. Apply the same scrutiny to marketing claims in this space as you would to any other unapproved use.

How do I know if a proposed use of regenerative medicine is appropriate for my condition?

Ask your provider directly whether the specific product and use are FDA-approved or investigational. Ask for records of where the cell product is sourced and processed. And get a second opinion if a clinic guarantees results.

References

Centers for Medicare & Medicaid Services. (2024, March 6). National coverage determination (NCD) for stem cell transplantation (110.23). U.S. Department of Health and Human Services.

Florida Legislature. (2025). Stem cell therapy (Fla. Stat. § 458.3245). The Florida Senate.

Goulian, A. J., Goldstein, B., & Saad, M. A. (2025). Advancements in regenerative therapies for orthopedics: A comprehensive review of platelet-rich plasma, mesenchymal stem cells, peptide therapies, and biomimetic applications. Journal of Clinical Medicine, 14(6), 2061.

Mayo Clinic. (n.d.). Stem cells: What they are and what they do.

Qiu, T., Pochopień, M., Hanna, E., Liang, S., Wang, Y., Han, R., Toumi, M., & Aballéa, S. (2022). Challenges in the market access of regenerative medicines, and implications for manufacturers and decision-makers: A systematic review. Regenerative Medicine, 17(3), 161–174.

U.S. Food and Drug Administration. (2020, July 22). Consumer alert on regenerative medicine products including stem cells and exosomes.

This article is for educational purposes only and is not a substitute for individualized medical advice. Regenerative medicine therapies discussed here, other than FDA-approved cord-blood-derived hematopoietic stem cell products, are investigational and are not FDA-approved to diagnose, cure, mitigate, treat, or prevent any specific disease.

Talk with a licensed physician about your specific condition, candidacy, and options before pursuing any treatment. Medically reviewed by Kenny Chantasi, DO. Last medically reviewed: August 5, 2026.

Related reading

• What Conditions Regenerative Medicine Is Used For
• How Do You Know If You’re a Good Candidate for Regenerative Medicine?
• How to Compare Orlando Regenerative Clinics
• What Is Regenerative Medicine? An Orlando 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.