By Alvin Philipose, DC (Ret.), Clinic Director · Part of our guide to Stem Cells & Exosomes in Oklahoma
“Experimental” does not have to mean “off the books.” There are four lawful routes to investigational treatment in Oklahoma. Each has its own eligibility rules, and each depends on a willing physician and a willing manufacturer or sponsor.
1. Clinical trials
Who it’s for: patients who meet a trial’s inclusion criteria.
How it works: trials are registered on ClinicalTrials.gov, run under an FDA IND and overseen by an institutional review board (IRB).
Cost: the investigational product is usually provided at no charge; travel and standard care may not be.
Good to know: some trials have placebo arms. Trial records list the sponsor, sites and contact information.
2. FDA expanded access (“compassionate use”)
Who it’s for: patients with a serious or immediately life-threatening condition who have no comparable approved option and cannot enroll in a trial.
How it works: the physician asks the manufacturer to provide the product; if it agrees, the physician submits a single-patient IND (FDA Form 3926) and obtains IRB review. Emergency requests can be authorized by phone.
Good to know: the FDA authorizes the large majority of requests it receives. The usual obstacle is the manufacturer’s willingness to provide the product.
3. Federal Right to Try Act (2018)
Who it’s for: patients with a life-threatening disease or condition who have exhausted approved options and cannot participate in a clinical trial.
What qualifies: an investigational drug or biologic that has completed a Phase 1 clinical trial, is not approved, and is in active development or under an active IND.
How it works: the physician certifies eligibility, the patient gives written informed consent, and the manufacturer decides whether to provide it. FDA approval of the individual request is not required.
Good to know: products that have never been through a Phase 1 trial, including most commercial exosome products, do not qualify.
4. Oklahoma Right to Try for Individualized Treatments Act (SB 933)
Effective: November 1, 2026.
Who it’s for: patients with a life-threatening or severely debilitating illness, attested by their treating physician, who have considered all approved options and cannot join a clinical trial.
What qualifies: treatments produced uniquely for one patient based on that patient’s own genetic profile, such as individualized gene therapies, antisense oligonucleotides and individualized neoantigen vaccines.
How it works: a licensed physician (MD or DO) recommends the treatment, the patient gives written informed consent, and an eligible facility, which under the national model act is an institution operating under a Federalwide Assurance for human-subject protection, works with the manufacturer.
Good to know: genetic testing comes first, because the treatment must be built from your genetic profile. Insurers and the state are not required to pay. Read our SB 933 page.
Side-by-side
| Clinical trial | Expanded access | Federal Right to Try | Oklahoma SB 933 | |
|---|---|---|---|---|
| Illness | Per trial | Serious or life-threatening | Life-threatening | Life-threatening or severely debilitating |
| Product stage | Under IND | Under IND | Phase 1 completed | Individualized to patient’s genetics |
| FDA sign-off per patient | Trial-level | Yes | No | No |
| IRB involvement | Yes | Yes | No | Through an FWA facility |
| Who pays | Sponsor, usually | Varies | Varies; often the patient | Usually the patient |
How Venturis Clinic helps you use these pathways
- Records review: we organize your diagnoses and document the approved treatments you’ve tried, which every pathway asks for.
- Genetic testing and genome sequencing through CLIA-certified labs.
- Trial and program search: we search registered trials and expanded-access programs relevant to your condition.
- Physician coordination: we prepare a summary your physician can use to evaluate a request, with oversight from our physician medical director.
We do not manufacture investigational products and cannot guarantee that a sponsor, manufacturer or facility will accept a request. Call (405) 848-7246 for a free 15-minute discovery call.
Educational information only, not legal advice. Sources: 21 U.S.C. 360bbb-0a (Right to Try Act); 21 CFR 312 Subpart I (expanded access); 21 CFR 312.81; Oklahoma SB 933 (2026).