Physician-guided pain care & longevity medicineMount Dora & Land O’ Lakes, Florida
Investigational / not FDA-approved for chronic pain
A MORE THOUGHTFUL APPROACH

Mesenchymal Stromal Cells (MSCs)

What is known—and unknown—about multipotent stromal-cell research.

Mesenchymal stromal cells, often called mesenchymal stem cells, are cell populations studied for their signaling and interactions with surrounding tissue. Research sources can include bone marrow, adipose tissue and perinatal tissues. Different sources and manufacturing processes yield non-equivalent products.

✓ Physician-guided✓ Informed decisions✓ Central Florida
Florida statutory stem-cell notice · §459.0127

THIS NOTICE MUST BE PROVIDED TO YOU UNDER FLORIDA LAW. This physician performs one or more stem cell therapies that have not yet been approved by the United States Food and Drug Administration. You are encouraged to consult with your primary care provider before undergoing any stem cell therapy.

This statutory notice does not itself establish FDA authorization or that any particular product or procedure can lawfully be administered.

01

How they are studied

Researchers examine immunomodulatory signaling, secreted factors, extracellular vesicles and responses to damaged tissue. These are mechanistic hypotheses and observations, not proof of clinical benefit.

02

Clinical conditions under investigation

Studies have explored MSCs for knee osteoarthritis, some inflammatory conditions and other disorders. Study populations, controls, dosing, routes, safety follow-up and results vary; MSC administration is not an established treatment for chronic pain.

03

The regulatory distinction

FDA approved Ryoncil (remestemcel-L-rknd), a bone marrow-derived MSC product, in December 2024 for steroid-refractory acute graft-versus-host disease in pediatric patients. This narrow approval does not apply to knee arthritis, back pain or neuropathy; no MSC product is FDA-approved to treat those conditions.

04

Safety and consent

Cell-based products have risks that may include contamination, unintended immune effects, abnormal tissue formation and complications of injection or infusion. Any legitimate investigational use must be evaluated under the applicable regulatory framework.

Answers & context

Frequently asked questions

Are MSCs approved for knee arthritis?+
No MSC product is FDA-approved to treat osteoarthritis.
Are MSCs and MUSE cells identical?+
No. MUSE cells are a distinct research-defined cell population; neither has established efficacy for chronic pain.
Is a supplier certificate FDA approval?+
No. Facility registration, accreditation and product certificates are not the same as FDA approval for an intended treatment.
We’re here to help

Have questions about the research?

Our team can explain the scientific and regulatory context. This does not represent an offer of investigational treatment.