Patients researching options beyond approved care often encounter two terms, Right to Try and expanded access, and assume they are interchangeable shortcuts to investigational therapy. They are neither interchangeable nor shortcuts. This guide explains what each actually requires, how they compare with a clinical trial, and why banking a person’s own tissue fits neither pathway directly while still preserving optionality.
TLDR: Right to Try and expanded access are two different pathways that may allow a patient with a life-threatening condition to seek a manufacturer’s investigational drug after approved options are exhausted and when no trial is available. Right to Try requires the drug to have completed Phase 1 and does not involve FDA review of the individual request, while expanded access involves the FDA and an institutional review board. Both require the manufacturer’s agreement, which is never guaranteed, and both apply to a manufacturer’s investigational product, not to a patient’s own banked tissue. Banking preserves a person’s own tissue for potential future use; it does not guarantee eligibility, access, or any clinical benefit.
Important Disclaimer: Save My Fat does not provide FDA-approved treatments or cures for any disease or condition. Banking adipose tissue today does not guarantee eligibility, access, or clinical benefit from any future therapy, clinical trial, or medical program. All content is for educational purposes only and does not constitute medical advice. Patients must consult their own licensed healthcare professionals regarding all medical decisions.
The confusion between these pathways is understandable, because both involve investigational products and serious illness. Clarifying the differences helps a patient understand what is realistic and where banking does and does not fit.
What Right to Try Actually Says
The federal Right to Try Act, enacted in 2018, created a pathway for certain patients with life-threatening conditions to seek access to an investigational drug without the FDA reviewing the individual request. To qualify, the patient must have a life-threatening condition, have exhausted approved treatment options, and be unable to participate in a relevant clinical trial. The drug must have completed a Phase 1 trial and remain in active development.
Two features are often missed. First, the manufacturer is not required to provide the drug; the company must agree, and many do not. Second, removing FDA review of the individual request does not remove the other realities of accessing an investigational product, including manufacturer willingness and the investigational nature of the drug. The overview of the Right to Try Act explains the law in more detail.
What Expanded Access Actually Says
Expanded access, governed by 21 CFR Part 312, Subpart I, is a pathway that may allow a patient with a serious or life-threatening condition to obtain a manufacturer’s investigational product when approved options are exhausted and no suitable trial is available. Unlike Right to Try, expanded access involves the FDA, which reviews the request, and an institutional review board.
As with Right to Try, the manufacturer must agree to provide the product, and a treating physician initiates the request rather than the patient. The overview of expanded access programs describes the mechanics, and the Reagan-Udall Foundation for the FDA maintains the Expanded Access Navigator to help patients and physicians understand the process. Expanded access is a pathway, not a guarantee.
Right to Try vs. Expanded Access vs. Clinical Trial: Comparison Table
The table compares the three routes at a glance.
| Feature | Right to Try | Expanded Access | Clinical Trial |
|---|---|---|---|
| Framework | Right to Try Act (2018, federal) | 21 CFR Part 312, Subpart I | FDA-regulated research protocol |
| Product | Manufacturer investigational drug, Phase 1 completed | Manufacturer investigational product | Manufacturer investigational product |
| FDA review of the individual request | Not involved in the individual request | FDA reviews the request | Conducted under an FDA-regulated protocol |
| Institutional review board | Not required for the individual request | Required | Required |
| Manufacturer agreement | Required; never obligated to provide | Required; never obligated to provide | Enrollment per protocol |
| Who initiates | Physician | Physician | Investigator-run; patient applies to enroll |
| Applies to a patient’s own banked tissue | No | No | No |
The bottom row is the point most relevant to banking: none of these routes applies to a patient’s own banked tissue.
Why Both Pathways Are Narrower Than Most Patients Assume
Both pathways are narrower than their names suggest. They apply only to patients with serious or life-threatening conditions who have exhausted approved options and cannot enter a relevant trial, and they depend on a manufacturer agreeing to provide an investigational product. The manufacturer’s agreement is often the limiting factor, because companies are not obligated to provide investigational products and may decline for many reasons.
For most patients, a clinical trial remains the most structured route to an investigational product, which is why it is usually the first avenue to discuss with a physician. The current active clinical trials show what is enrolling in the adipose-derived space. Right to Try and expanded access are generally considered only after trial options have been ruled out.
Where Banking Fits in This Picture
Banking fits none of these three routes directly, because all three concern a manufacturer’s investigational product, while banked tissue is a patient’s own preserved tissue. Banking does not enroll a patient in a trial, does not qualify a patient for Right to Try or expanded access, and is not a treatment. What it does is preserve a person’s own tissue so it exists if future FDA-regulated pathways, which may or may not develop, ever become relevant.
That is the accurate sense in which banking preserves optionality: it is a preservation decision made under uncertainty, not a key to any access pathway. For background on the service, the complete guide to banking explains what is preserved and why. Any future use depends on FDA regulatory status and the science at that time.
Frequently Asked Questions
Does Right to Try or expanded access let me use my banked tissue?
No. Both pathways apply to a manufacturer’s investigational product, not to a patient’s own banked tissue. Banking does not qualify a patient for either route.
What is the main difference between Right to Try and expanded access?
Right to Try does not involve FDA review of the individual request and requires the drug to have completed Phase 1, while expanded access involves the FDA and an institutional review board. Both require the manufacturer to agree to provide the product.
Can I use Right to Try without my doctor?
No. A treating physician initiates the request. Right to Try also requires a life-threatening condition, exhausted approved options, and inability to participate in a relevant trial.
Is a clinical trial usually the better route?
For most patients, a clinical trial is the most structured route to an investigational product and the first to discuss with a physician. Right to Try and expanded access are generally considered only when no suitable trial is available.
Does banking guarantee future access to therapy?
No. Banking preserves a person’s own tissue for potential future use. It guarantees no eligibility, access, or clinical benefit, and any future use depends on FDA regulatory status and the science at that time.
Key Takeaways
For patients weighing these terms, the practical reality is clearer than the marketing around them. Right to Try and expanded access are two different pathways that may allow a patient with a life-threatening condition to seek a manufacturer’s investigational drug after approved options are exhausted and when no trial is available, with Right to Try requiring Phase 1 completion and no FDA review of the individual request, and expanded access involving the FDA and an institutional review board. Both require the manufacturer’s agreement, which is never guaranteed, and both apply to a manufacturer’s investigational product rather than to a patient’s own banked tissue. A clinical trial is usually the most structured route and the first to discuss with a physician. Above all, banking adipose tissue is a preservation service for potential future use; it is not a treatment, and it does not guarantee eligibility, access, or clinical benefit.
Save My Fat operates as a tissue preservation service, not a medical practice or treatment provider. Stem cell and regenerative medicine regulations vary by state, including specific informed-consent and disclosure requirements in Florida, Utah, and Nevada governing tissue and stem cell services. Banking adipose tissue does not connect patients to any treatment pathway, and any future use depends on FDA regulatory status, physician guidance, and the availability of approved or investigational pathways at that time.
Patients who want to understand what banking does and does not offer can review the complete guide and contact the team with questions.
Save My Fat partners with L2 Bio for laboratory processing and storage.
This article is for educational purposes only and does not constitute medical or legal advice. Legal and medical review is required before publication. Please consult your physician before making any decisions about treatment or research participation.
Related guide: the physician resource center.
Related reading: the physician’s guide to these two pathways.
