FDA Disclaimer: Stem cell therapies referenced on this page have not been evaluated or approved by the U.S. Food and Drug Administration (FDA). These therapies are not intended to diagnose, treat, cure, or prevent any disease. Rebuild Regen Medical Clinic provides stem cell therapy under the supervision of our Medical Director, [MD_PLACEHOLDER] MD, in compliance with Florida SB 1768.

Florida Stem Cell Law SB 1768: 3 Requirements Every Patient Should Know Before Treatment

Florida stem cell law, specifically Senate Bill 1768 (effective July 1, 2025), authorizes the use of non-FDA-approved stem cell therapies in Florida exclusively under the supervision of licensed physicians holding Chapter 458 (MD) or Chapter 459 (DO) licenses.

This page explains what SB 1768 means for patients, what it requires of providers, and how Rebuild Regen Medical Clinic meets its requirements.

What Florida SB 1768 Is: The Legal Authorization for Stem Cell Therapy

Florida stem cell law represents a legislative framework that Florida enacted to provide a legal pathway for the clinical use of stem cell therapies that are not currently FDA-approved as drugs or biologics. Before SB 1768, the regulatory landscape for these therapies was ambiguous in Florida, creating uncertainty for both patients and providers.

SB 1768 resolves this ambiguity by establishing specific conditions under which non-FDA-approved stem cell therapies are legally authorized in Florida. It does not make these therapies FDA-approved. It creates a state-law framework for their use that coexists with federal regulatory requirements.

The law is significant for patients in Florida who want access to stem cell therapies for conditions including orthopedic degeneration, neuropathy, systemic inflammation, and autoimmune conditions, where conventional medicine offers limited options and regenerative approaches have clinical rationale and a real (if not yet FDA-approved) evidence base.

The 3 Requirements of Florida SB 1768 That Every Patient Should Understand

Requirement 1: Physician Supervision by a Chapter 458 or Chapter 459 Licensed Physician

SB 1768 requires that non-FDA-approved stem cell therapy be performed or supervised by a licensed physician holding a Florida Chapter 458 (MD) or Chapter 459 (DO) license. Nurse practitioners, physician assistants, and other non-physician providers cannot independently administer stem cell therapy under SB 1768. Physician supervision is mandatory.

This requirement exists to ensure that stem cell therapies are administered within a clinical context that includes physician-level medical judgment: the ability to assess candidacy, evaluate risks, manage adverse events, and provide the highest level of oversight for an investigational procedure.

At Rebuild Regen Medical Clinic, [MD_PLACEHOLDER] MD serves as Medical Director and holds the appropriate Florida physician license. [MD_PLACEHOLDER] MD supervises all stem cell protocols. Elizabeth Celestin, APRN, FNP-C manages the clinical relationship, intake, and follow-up, but stem cell administration occurs under physician supervision.

This is the SB 1768 compliance structure at Rebuild Regen: a two-provider team that meets the physician supervision requirement while providing the clinical depth of a nurse practitioner-led practice.

Requirement 2: Patient Informed Written Consent Acknowledging the Investigational Nature of the Treatment

SB 1768 requires that patients provide written informed consent before receiving non-FDA-approved stem cell therapy. The consent must acknowledge that:

The therapy has not been FDA-approved
The therapy is investigational
The patient understands the risks, benefits, and alternatives as disclosed by the provider
The patient's consent is voluntary

The informed consent process at Rebuild Regen is not a boilerplate form signing. It is a clinical conversation. The investigational status of the therapy, the FDA disclaimer, the evidence base, the realistic expectations, and the alternatives are all discussed during the consultation before any consent is requested.

The consent form is specific to the therapy, the patient, and the clinical context.

Requirement 3: Clinical Setting Requirements

SB 1768 requires that the clinical setting meet applicable state and federal facility requirements for the administration of biologics and the supervision of medical procedures.

Rebuild Regen Medical Clinic at 3320 N Federal Hwy #101, Lighthouse Point, FL 33064 operates in a medical office setting that meets the applicable facility requirements. The biologics used (DayZero™ from ZEO ScientifiX) are sourced from an FDA-registered, cGMP facility registered under 21 CFR Part 1271. The treatment environment meets the standards required for clinical biologic administration.

What SB 1768 Does Not Do

SB 1768 does not make stem cell therapy FDA-approved. This is an important distinction. The law provides a state-level authorization pathway; it does not confer federal regulatory approval.

SB 1768 does not eliminate the requirement for a physician. Florida law requires physician supervision as a condition of legal use. Providers who offer stem cell therapy without physician oversight are not compliant with SB 1768.

SB 1768 does not guarantee efficacy or safety. The investigational nature of the therapy is explicitly acknowledged in the law. The clinical rationale, the evidence base, and the realistic expectations are all topics for the consultation with your provider.

Why SB 1768 Matters for Patients: Comparing States

Florida's SB 1768 places it among a growing group of states that have enacted stem cell therapy access laws providing a supervised pathway for investigational regenerative therapies. Not all states have equivalent frameworks.

Patients from states where stem cell therapy is more heavily restricted or where the regulatory environment is less clear often travel to Florida specifically because SB 1768 provides a legal, physician-supervised framework for the therapy they are seeking. Rebuild Regen's location in Lighthouse Point is accessible from Fort Lauderdale-Hollywood International Airport (FLL), approximately 20 minutes from the clinic.

How Rebuild Regen Complies With SB 1768

Rebuild Regen Medical Clinic meets all three SB 1768 requirements:

[MD_PLACEHOLDER] MD, Florida Chapter 458 licensed physician, serves as Medical Director and supervises all stem cell protocols.
Written informed consent is obtained from every stem cell patient before treatment, explicitly acknowledging the investigational nature of the therapy and the FDA non-approval status.
The clinic operates in a medical office facility. DayZero™ biologics are FDA-registered, cGMP, and 21 CFR Part 1271 registered.

The stem cell therapy page and the complete stem cell guide provide additional detail on the specific protocols, products, and clinical process.

Is Stem Cell Therapy Right for You Under Florida Law?

Florida SB 1768 provides the legal framework. The clinical framework is the consultation with Elizabeth Celestin, APRN, FNP-C and [MD_PLACEHOLDER] MD.

Patients who are appropriate candidates for stem cell therapy under SB 1768 are those with conditions for which regenerative biologics have clinical rationale, who understand the investigational status of the therapy, who can provide informed consent freely and voluntarily, and who have no clinical contraindications.

The consultation at Rebuild Regen is the appropriate place to determine whether stem cell therapy is right for your specific condition and whether you meet the candidacy criteria.

When Stem Cell Therapy Under SB 1768 Is Not Appropriate

SB 1768 compliance does not override clinical contraindications. Patients with active cancer, active infection at the intended treatment site, or conditions that require a different primary intervention are not appropriate stem cell candidates regardless of the legal framework.

Additionally, SB 1768 requires physician supervision, informed consent, and appropriate clinical setting. Providers who offer stem cell therapy without meeting these three requirements are not SB 1768 compliant, regardless of what their marketing states. Patients are encouraged to ask directly whether the supervising physician is a Florida Chapter 458 or 459 licensee and whether their informed consent includes explicit acknowledgment of the FDA non-approval status.

Contact Rebuild Regen Medical Clinic at (954) 953-4208 or visit 3320 N Federal Hwy #101, Lighthouse Point, FL 33064.