Does Florida approval mean the treatment is FDA approved?

No. Florida law and FDA approval are separate matters. Florida's required advertising notice itself specifically informs patients that a physician may perform stem-cell therapies that have not yet been FDA approved.

Are all stem-cell treatments the same?

No. Stem-cell products can differ significantly in their source, processing, composition, intended use and regulatory status.

Does stem cell therapy cure arthritis or joint pain?

The FDA states that regenerative medicine therapies have not been approved to treat orthopedic conditions including osteoarthritis, back pain, hip pain, knee pain, neck pain and shoulder pain.

How do I know whether a treatment is right for me?

That decision should be made after an individual medical evaluation and a discussion of the proposed therapy, available evidence, potential risks and benefits, alternatives and regulatory status.

Stem Cell Therapy Jacksonville FL | Patient Information

At Jax Medi Spa, we believe patients should have clear information before considering any medical treatment. Stem cell therapy is an evolving area of regenerative medicine that continues to be studied for its potential applications.

If you are considering stem cell therapy in Jacksonville, Florida, our goal is to help you understand what stem cells are, how these therapies are being studied, their regulatory status, potential risks and benefits, and questions you should discuss with a qualified medical provider before making a decision.

Stem cells are cells that have the ability to develop into different types of cells under certain biological conditions. Researchers have studied stem cells and other regenerative medicine products for a wide range of potential medical applications.

The term "stem cell therapy" can describe very different products and procedures. The source of the cells, how they are processed, how they are administered, and their intended use can affect how a particular product is regulated.

Patients should therefore understand exactly what product is being proposed rather than assuming all treatments described as "stem cell therapy" are the same.

This is one of the most important questions patients should ask.

The FDA regulates regenerative medicine products, including stem-cell products. According to the FDA, the stem-cell products currently FDA-approved in the United States are blood-forming stem cells derived from umbilical cord blood for certain disorders affecting blood production. The FDA states that these products are not approved for other uses.

This means that the ability to provide a particular therapy under Florida law should not be interpreted to mean the therapy has been approved by the FDA.

Florida law establishes requirements under which qualifying physicians may conduct certain stem-cell therapies that have not yet received FDA approval.

The law includes requirements involving physician responsibilities, product sourcing and facilities, advertising disclosures and informed patient consent.

Florida's requirements do not eliminate federal regulation of stem-cell products.

Patients considering treatment should discuss both the regulatory status of the specific product and the proposed use with their medical provider.

Before undergoing any stem-cell procedure, consider asking your medical provider:

What specific stem-cell product would be used?
Where does the product come from?
Is this particular product FDA approved?
Is this particular use FDA approved?
What research is available for the proposed use?
What potential benefits have been reported?
What are the known and potential risks?
What alternative treatments are available?
What happens if the treatment does not produce the anticipated result?
Who will perform the procedure?
What training and experience does the physician have?
What follow-up care is required?

Patients should have an opportunity to ask questions and understand their alternatives before deciding whether to proceed.

No medical procedure is risk-free.

The FDA has reported safety concerns associated with unapproved regenerative medicine products, including infections, inflammatory or immune reactions, tumor formation, cross-contamination and other complications.

The risks associated with an individual procedure can vary depending on the product, its source and processing, method of administration, patient's medical history and intended use.

Your medical provider should discuss the risks that apply to the specific therapy being considered.

Regenerative medicine is a developing field, and information available online can sometimes make it difficult to distinguish established medical evidence from promotional claims.

Our approach is to encourage informed conversations between patients and qualified medical professionals.

A consultation should provide an opportunity to discuss:

Your medical history
The specific product being considered
The proposed procedure
Potential risks and anticipated benefits
FDA approval status
Available alternatives
What current research does and does not establish

Is stem cell therapy legal in Florida?
Florida law establishes circumstances and requirements under which qualifying physicians may conduct certain stem-cell therapies that have not yet been approved by the FDA. This should not be confused with FDA approval of the therapy itself.
Does Florida approval mean the treatment is FDA approved?
No. Florida law and FDA approval are separate matters. Florida's required advertising notice itself specifically informs patients that a physician may perform stem-cell therapies that have not yet been FDA approved.
Are all stem-cell treatments the same?
No. Stem-cell products can differ significantly in their source, processing, composition, intended use and regulatory status.
Does stem cell therapy cure arthritis or joint pain?
The FDA states that regenerative medicine therapies have not been approved to treat orthopedic conditions including osteoarthritis, back pain, hip pain, knee pain, neck pain and shoulder pain.
How do I know whether a treatment is right for me?
That decision should be made after an individual medical evaluation and a discussion of the proposed therapy, available evidence, potential risks and benefits, alternatives and regulatory status.