By Alvin Philipose, DC (Ret.), Clinic Director, Venturis Clinic, Oklahoma City · Updated October 2026

Patients in Oklahoma City, Tulsa and across the state ask us the same questions every week: Are stem cells legal? Are exosomes FDA-approved? What changes when Oklahoma’s new Right to Try law takes effect? This page lays out the answers plainly, using the FDA’s own framework, so you can tell the difference between what is approved, what is investigational but legally accessible, and what is being sold without a lawful pathway.

Venturis Clinic’s role is navigation: genetic testing, screening, documentation and coordination with the physicians, trials and facilities that can lawfully provide investigational care. Our clinical team works under physician medical director oversight.

The short answer

FDA-approved: a small number of stem cell products exist, almost all cord blood products for blood and immune disorders, plus one mesenchymal stromal cell product (Ryoncil) for a specific pediatric transplant complication. See the full list.
Exosomes: the FDA states there are no FDA-approved exosome products. Exosomes intended to treat a disease are regulated as drugs and biological products. Read the details.
Investigational but legally accessible: clinical trials, FDA expanded access, the federal Right to Try Act, and, beginning November 1, 2026, Oklahoma’s Right to Try for Individualized Treatments Act (SB 933). Compare the pathways.
Your own tissue, same procedure: some autologous procedures, such as platelet-rich plasma prepared with FDA-cleared devices, operate under a different framework than donor cell products.

How the FDA classifies cell and tissue products

Stem cells, exosomes, cord tissue and similar products fall under the FDA’s rules for human cells, tissues, and cellular and tissue-based products (HCT/Ps), found in 21 CFR Part 1271. Every product ends up in one of two lanes.

Lane 1: “361” products (lower risk, no premarket approval)

A product is regulated only under Section 361 of the Public Health Service Act when it meets all four criteria in 21 CFR 1271.10(a):

Minimally manipulated: processing does not alter the original relevant characteristics of the tissue or cells.
Homologous use: it performs the same basic function in the recipient as in the donor.
Not combined with another article (aside from water, crystalloids, or a sterilizing, preserving or storage agent).
No systemic effect and not dependent on the metabolic activity of living cells, unless it is autologous, from a close relative, or reproductive.

Separately, 21 CFR 1271.15(b) exempts a facility that removes a patient’s own tissue and implants it back into that patient during the same surgical procedure.

Lane 2: “351” products (drugs and biologics)

Anything that fails one of those criteria is regulated as a drug and biological product. It needs an Investigational New Drug application (IND) to be studied in people and a Biologics License Application (BLA) to be marketed. The FDA ended its enforcement-discretion period for these products on May 31, 2021, and continues to issue warning letters, including in 2026, to companies marketing umbilical cord, Wharton’s jelly and exosome products outside an IND.

Exosomes, explained

Exosomes are tiny vesicles, a fraction of the size of a cell, that cells release to carry proteins, lipids and RNA to other cells. They have no nucleus and cannot divide. Research interest is intense because they appear to carry much of the signaling activity once credited to stem cells themselves. They are also hard to standardize: source cell, culture conditions, isolation method and dose all change what is in the vial.

Exosomes come from many sources: mesenchymal stromal cells from bone marrow, fat or umbilical tissue; platelets; placental and amniotic tissue; plants; and engineered cell lines. Each has different research behind it. Our guide to the types of exosomes walks through each one.

Stem cells, explained

“Stem cell” covers very different things: blood-forming stem cells used in bone marrow and cord blood transplants, mesenchymal stromal cells (MSCs) from bone marrow, fat or umbilical tissue, induced pluripotent stem cells made in a lab, and embryonic stem cells. Whether the cells are your own (autologous) or from a donor (allogeneic) matters both medically and legally. Read our guide to stem cell types.

Approved, investigational, and unapproved: a quick map

Category	Examples	Lawful pathway
FDA-approved cell products	Cord blood HPC products, Omisirge, Ryoncil, MACI, Lantidra	Prescribed for approved uses by qualified centers
Investigational biologics	MSC products and exosome products studied for specific conditions	Clinical trial, expanded access, federal Right to Try (if Phase 1 is complete)
Individualized investigational treatments	Treatments produced for one patient from their own genetic profile, such as antisense oligonucleotides or neoantigen vaccines	Oklahoma SB 933, starting November 1, 2026, for eligible patients through eligible facilities
Autologous same-procedure care	Platelet-rich plasma prepared with FDA-cleared devices	Physician-directed care; not an FDA-approved indication for a specific disease

Oklahoma’s Right to Try for Individualized Treatments Act (SB 933)

Senate Bill 933 was signed into law in 2026 and takes effect November 1, 2026. It creates a state pathway for patients with a life-threatening or severely debilitating illness, who have considered or exhausted approved options, to request treatments made specifically for them based on their own genetic profile, with their physician’s recommendation and written informed consent.

Two points get lost in the headlines. First, the law is built around individualized treatments; off-the-shelf donor stem cell or exosome products are not the same thing. Second, individualized treatments are provided through eligible facilities, defined in the national model act as institutions operating under a Federalwide Assurance for the protection of human subjects. Read our SB 933 announcement and join the screening list.

What Venturis Clinic offers

Genetic testing and genome sequencing through CLIA-certified laboratories, the foundation of any individualized pathway.
Access navigation: we review your records, document which approved options you have tried, search registered clinical trials, and help your physician evaluate expanded access, federal Right to Try or SB 933.
Coordination with outside physicians, trial sites and eligible facilities, and organized records you can take with you.
Case documentation program: a voluntary, consent-based program for patients who want their course of care documented.

Injections at Venturis, such as PRP, are administered by medical staff. Our clinical team includes a physician medical director, a physician assistant and two nurses.

How to protect yourself

Ask any clinic offering stem cells or exosomes three questions: Is this product FDA-approved for my condition? If not, what is the IND number or registered trial? Who manufactured it, and can I see the certificate of analysis? Our guide to choosing a stem cell clinic lists the red flags.

Frequently asked questions

Are stem cell treatments legal in Oklahoma?

FDA-approved stem cell products are legal for their approved uses. Investigational products are legal to receive through a clinical trial, FDA expanded access or the federal Right to Try Act. Federal FDA law applies in every state, including Oklahoma.

Does SB 933 make exosomes legal?

No. SB 933 covers treatments produced uniquely for one patient from that patient’s genetic profile. It does not approve exosome or donor stem cell products, and it does not change federal law.

Can Venturis Clinic tell me whether I qualify?

We can screen your records against the published eligibility criteria and help your physician decide whether a pathway is realistic. Final eligibility rests with the treating physician, the trial or facility, and the manufacturer.

Does insurance pay for investigational treatment?

Generally not. SB 933 does not require insurers or the state to pay, and patients usually bear the cost of investigational treatment.

Explore this guide

Join the SB 933 screening list or call (405) 848-7246 to book a free 15-minute discovery call.

Educational information only, not medical or legal advice. Stem cell-derived and exosome products discussed on this page are not FDA-approved unless specifically stated. Venturis Clinic does not manufacture investigational products and cannot guarantee access to any treatment, trial or facility. Sources: FDA, 21 CFR Part 1271; FDA Public Safety Notification on Exosome Products (Dec. 2019); FDA list of Approved Cellular and Gene Therapy Products; Oklahoma SB 933 (2026).

Stem Cells & Exosomes in Oklahoma: FDA Rules and Legal Access