People ask us this all the time, and the honest answer is: no one can predict exactly when you’ll use your stem cells—or what you’ll use them for. But we can explain what’s true today, what’s changing fast, and why banking your cells can matter over the long term.
Most people do not have a routine, FDA-approved reason to use their own banked mesenchymal stromal cells (MSCs) right now for general wellness or “rejuvenation.” In the U.S., cell therapies that become widely available typically go through years of clinical trials, manufacturing validation, and FDA review.
That said, progress is real and measurable:
- The FDA’s Office of Therapeutic Products (OTP) now lists dozens of licensed cellular and gene therapy products (including CAR-T therapies, gene therapies, cord blood products, and tissue-engineered products). As of the FDA page “content current as of 12/09/2025,” that list includes 48 approved products.
- In December 2024, the FDA approved Ryoncil (remestemcel-L-rknd) — the first FDA-approved mesenchymal stromal cell (MSC) therapy in the United States (for steroid-refractory acute graft-versus-host disease in pediatric patients). That approval is an important milestone for the MSC field.
Even with that momentum, it’s important to understand what “progress” does—and doesn’t—mean:
- Many approved cell/gene therapies are highly disease-specific and are not designed as elective or preventive treatments.
- Many products are engineered (gene-modified) or donor-derived, not simply “use your own stored cells.”
- Your banked MSCs are best thought of as future-ready biological starting material—young, personal cells preserved for the kinds of therapies that may become available as the science and regulation mature.
Your cells are cryopreserved at the age you banked them. As you get older, the “age gap” between you today and your stored cells grows—one reason people view banking as a long-term option strategy rather than something they expect to use next month.
Also, the regulatory and development ecosystem is becoming more mature:
- The FDA created the Office of Therapeutic Products (OTP) to strengthen oversight and keep pace with the growth of cell and gene therapies.
- In January 2026, the FDA described additional regulatory flexibilities intended to help speed responsible development (especially around manufacturing/CMC expectations).
