Seven common questions about precision biologics cover what the term means, how they are thought to work, how they are regulated, who may be a candidate, what results to expect, what is known about safety, and how to find a credentialed provider. In short, as used here, "precision biologics" is a descriptive label, not an FDA category, for therapies made from human cells, tissues, or substances that cells release. The FDA has not approved any stem cell or exosome product for joint conditions, and individual results vary.
This article is educational, not medical advice.
What are precision biologics, and how do biologics differ from conventional drugs?
Short answer: "Precision biologics" is not a regulatory category, an FDA-recognized term, or a measure of quality, safety, or effectiveness. Used here only as a descriptive label, it refers to therapies derived from living sources, such as human cells, tissues, or the particles cells release, rather than from chemically synthesized compounds.
The FDA notes that most conventional drugs are chemically synthesized with a known structure, while most biologics are complex mixtures that are harder to identify and characterize (FDA: What Are "Biologics"?). That is a difference in how products are made and regulated, not a ranking. Many FDA-approved biologics, such as vaccines and insulin, are part of everyday conventional medicine.
Where stem cells and exosomes fit
Clinical research on MSCs is further along than research on exosomes, where the evidence is early and comes largely from laboratory and early-phase studies. See our pages on Wharton's Jelly and exosomes.
How are biologic therapies thought to work?
Short answer: The main proposed mechanism is signaling rather than replacement of damaged tissue. Researchers are studying whether those signals may influence inflammation and the surrounding tissue environment, but how much this matters for people is still being worked out.
Laboratory studies show that MSCs release growth factors and other signaling molecules, and that exosomes carry molecular cargo between cells. These laboratory findings do not show that an injection produces a lasting benefit in a person, and no currently available injection has been shown to rebuild a worn-out joint. Sourcing, dose, and delivery route may also affect safety and results.
Are biologic therapies regulated, and where do they come from?
Short answer: Yes, the FDA regulates them, but regulated is not the same as approved. As of October 2026, the FDA has not approved any exosome product, and no stem cell or exosome product is FDA-approved for joint conditions. The FDA has approved a small number of stem cell products for specific other conditions, such as cord blood-derived blood-forming stem cell products for certain blood disorders and one mesenchymal stromal cell product for a pediatric complication of stem cell transplant (FDA: Approved Cellular and Gene Therapy Products).
Human cells and tissues intended for use in people are regulated as HCT/Ps under 21 CFR Part 1271 (FDA: Tissue & Tissue Products). Products that meet specific criteria, including minimal manipulation and homologous use (FDA guidance), fall under Section 361 of the Public Health Service Act. Others are generally regulated as drugs and biological products, which need FDA premarket review: an Investigational New Drug (IND) application for clinical investigation and an approved Biologics License Application for marketing.
The FDA's consumer information on regenerative medicine therapies lists Wharton's jelly and exosomes among unapproved products and states that none are approved for orthopedic conditions such as osteoarthritis, tendonitis, or knee, hip, or shoulder pain. For joint and other musculoskeletal uses, these products are not FDA-approved, and the FDA says unapproved products generally need FDA oversight, such as an IND, to be legally administered. Ask any provider what regulatory pathway applies to the specific product. The FDA also notes that a firm's FDA registration, or a listing in a clinical trial database, does not mean its product is legally marketed.
How donor sourcing works
FDA rules require HCT/P establishments to screen and test donors and follow written procedures to prevent the spread of communicable disease (FDA: Tissue & Tissue Products). Wharton's Jelly is the gelatinous connective tissue of the umbilical cord. Suppliers report collecting it with informed donor consent after healthy, full-term births, and no embryonic tissue is used. Regenerative Revival sources Wharton's Jelly tissue products from tissue banks accredited by the Association for Advancing Tissue and Biologics (AATB). Donor screening rules and accreditation are sourcing quality markers; they do not make a product FDA-approved or risk-free.
Who is a candidate for biologic therapy?
Short answer: There is no single candidate profile. Candidacy is an individual clinical decision, and some people are not candidates. Clinicians typically weigh:
These therapies are not expected to replace tissue that is already lost, so advanced structural damage may call for other options.
What results can you expect, and is any outcome guaranteed?
Short answer: It varies, and no outcome is guaranteed. Some study participants have reported improvement and some have not, and timelines differ across studies and conditions.
Results for MSC injections in knee osteoarthritis are mixed. A 2021 meta-analysis of 13 randomized trials found intra-articular MSC injections no different from placebo for knee osteoarthritis pain and function (Arthroscopy, 2021), while a 2025 meta-analysis of 8 randomized trials reported improvements in pain and overall knee symptom scores (WOMAC and VAS) compared with control groups at 6 and 12 months (Stem Cell Research & Therapy, 2025). Trials vary in cell source, dose, and quality, and many are small. Evidence specific to Wharton's Jelly is more limited still. The 2025 analysis pooled only trials of bone marrow- and fat-derived cells, not Wharton's Jelly tissue products, so these results should not be assumed to apply to any particular product. Even when people respond, lasting results are not guaranteed. Individual results vary.
What is known about the safety and risks of biologic therapies?
Short answer: Safety depends on the specific product, how it is sourced and handled, and how it is given. In one systematic review of MSCs given into the bloodstream, fever was the main adverse event associated with treatment. That review did not study joint injections, and human safety data for exosomes are much more limited. No injection is risk-free.
A 2020 systematic review and meta-analysis (literature searched through May 2018) of 55 randomized trials (2,696 adults) of MSCs given into the bloodstream found an increased risk of fever compared with control groups, but no significant increase in infection, blood clots, death, or cancer (Thompson et al., 2020). It excluded studies that used only non-intravascular routes, such as joint injection, so its findings may not apply to every product, route, or use.
In a 2019 public safety notification, the FDA reported serious adverse events in patients in Nebraska who were treated with unapproved products marketed as containing exosomes (FDA public safety notification). More broadly, the FDA has received reports of serious harm, including infections, linked to unapproved regenerative medicine products, and any injection carries risks such as pain, swelling, bleeding, and infection.
How do you find a credentialed provider for biologic therapies?
Short answer: Start with a consultation in which a licensed clinician reviews your history, imaging, and prior treatments, explains what is and is not known, and tells you honestly whether you are a candidate.
Regenerative Revival is a concierge regenerative medicine company that works with a network of more than 100 licensed clinicians, with physician oversight through Arora Health Group. For appropriate candidates, a licensed clinician can provide in-home regenerative care where available. Availability varies by location (see our locations page and concierge care model). The Wharton's Jelly and exosome products discussed in this article are not FDA-approved, and you are welcome to ask about their regulatory status at any consultation.
Separately, Regenerative Revival offers hormone therapy, peptide protocols, and NAD+ therapy by telehealth in all 50 states. These are separate programs and are not required for regenerative care. The NAD+ products, peptide products, and compounded hormones offered through these services are not FDA-approved, and the FDA does not verify the safety, effectiveness, or quality of compounded drugs before they are marketed (FDA: Compounding and the FDA).
Questions to ask any provider
A good clinician should welcome these questions, and vague answers are a reason to pause. For independent reading, see the FDA's consumer information and the ISSCR's patient resources.
Next steps
If you would like to talk through whether any of this applies to you, take the 2-minute consult quiz or contact the team. A consultation is a medical conversation and can end with a "no."
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