First edition · 2026 · ISBN 979-8-9978915-0-3 (PDF)
When Standard Options Fall Short: Legal Access Pathways in Regenerative Medicine — for Patients and Physicians
The book does not evaluate or endorse any product, clinic, or physician. It maps pathways that already exist so patients and physicians can navigate them with greater clarity, discipline, and care.
How to use this book
Chapters 1–17 carry the full decision framework and are the only section meant to be read start to finish. Everything after it applies that framework by state, by pathway strength, and by condition.
Contents
How to Use This Book
Separate entry points for patients, families, and physicians.
p. 8
Chapters 1–17
The only section meant to be read start to finish.
p. 10
Part II — State Access Guides
Sixteen alphabetical maps, Arizona through Wyoming.
p. 75
Cross-State Pathway Summary
Formal-pathway comparison, then states without a statute.
p. 155
Pathways by Condition
Start with a diagnosis, not a state.
p. 159
Appendix — All 50 States
Seven operative statutes in full; condensed entries for the rest.
p. 188
Glossary
How this book uses the technical terms.
p. 228
The Language of the Access Pathway
The conversational vocabulary from first call to follow-up.
p. 235
References
Sources behind the statutes and findings.
p. 240
Index
Lookup by topic, statute, and state.
p. 245
About the Author
Tucson Dunn II.
p. 254
Why these pathways exist, how to evaluate an option honestly, how to prepare, how to work with a physician, how to read documentation, and how to live with the uncertainty that remains.
Part II · page 75
Alphabetical maps for Arizona through Wyoming. Seven states have an operative regenerative-medicine statute: Florida, Georgia, Montana, North Carolina, Tennessee, Texas, and Wyoming. A formal pathway is not automatically the easiest real-world route.
SB 1768 / Chapter 2025-185
Part II · page 89
Structured pathway for qualifying viable stem-cell products from accredited, FDA-registered facilities. Formal uses are limited to orthopedics, pain management, and wound healing. Exosomes sit outside the statute. Residual FDA overlay remains.
Residual FDA authority over unapproved biologics applies in every state. A statute is a map, not a waiver.
Page 155. A high-level comparison of what each formal pathway actually covers — product types, named conditions, and whether exosomes sit inside or outside the statute — then states without a dedicated regenerative law.
Page 188. Quick-reference table for every state, full statutory reconstruction for the seven operative statutes, and condensed entries for the remaining forty-three plus the District of Columbia.
Pathways by condition · page 159
Each entry answers the evidence question first, then the pathway question. A fast legal route is never presented as a substitute for supporting evidence. Autism and migraine are omitted on purpose — evidence against, and no dedicated human trial, respectively.
Chronic kidney disease
The book’s fullest worked example, through Chapter 15.
Traumatic brain injury
Florida’s statute excludes TBI by scope. Evidence remains preclinical.
Orthopedic and musculoskeletal
The most common commercial use; Florida’s three named indications include it.
Alzheimer’s disease
Pathway and evidence are treated as separate questions.
Parkinson’s disease
State maps applied to a progressive neurologic diagnosis.
COPD
Speed of access is never presented as a substitute for evidence.
Wound healing and psoriasis
Florida names wound healing; other states do not.
Epilepsy and peripheral nerve
A shorter shared note; same legal questions as related entries.
Anti-aging / longevity / skin
A different legal picture, addressed on its own terms.
About the author · page 254
More than two decades in senior hospital and health-system executive roles across the United States, the United Kingdom, Europe, the Middle East, and Asia — including Boston University Medical Center, University of Chicago Hospitals, Dana-Farber Cancer Institute, and major private hospital groups in Scotland, Indonesia, the Philippines, Thailand, Malaysia, China, the UAE, Poland, and Vietnam.
In that work he repeatedly encountered a practical barrier: even when a therapy had national regulatory approval, hospital Therapeutic Committees could delay or block access for months or years. Physician-owned clinics often provided faster, more direct pathways.
In 2018 he moved from the provider side into biotech manufacturing, focusing on stem cells and extracellular particles (exosomes). In Europe he contributed to early national ATMP authorizations under Hospital Exemption frameworks. That dual view — hospital executive and manufacturer — is the reason the book stays practical.
Copies
First edition, 2026. PDF, $29. Forthcoming October 2026. ISBN 979-8-9978915-0-3. Write to author@accessbeforeapproval.com.
Dedicated to Nataliia, Matvii, and Michelle.