Stem cell research is maturing rapidly, with over 750 registered clinical trials since 2020 utilizing mesenchymal stem cells (MSCs) to target some of the most challenging health conditions of our time. From repairing joint damage in osteoarthritis to exploring treatments for heart disease, kidney disease, and even Alzheimer’s disease, the potential to regrow and repair tissue is no longer science fiction—it’s now the modern frontier of longevity science.
Today, regenerative medicine offers a unique opportunity to harness your biology to extend your healthspan. Countries such as South Korea have approved stem cell treatments for ALS and acute myocardial infarction, while select European Union countries have approved the use of stem cells for Avascular Necrosis. In the U.S., healthcare providers are increasingly integrating these therapies into orthopedic and cosmetic medicine. Several U.S. states including Florida, Texas, and New Hampshire are also adopting new legislation in support of stem cell therapy expansion.
But as science advances, it can be hard to separate fact from fiction. Myths continue to circulate about where stem cells come from, whether they’re safe, and how they can be used in clinical settings. We’ve broken down the five biggest myths our providers are hearing in their clinics to help you learn the latest and make better decisions for your health.
The Reality: This is false. The FDA classifies stem cells as human cells, tissues, or cellular/tissue-based products (HCT/Ps). They are not regulated as drugs or medical devices if they are minimally manipulated—meaning the isolation process doesn't alter their biological characteristics—and are intended for homologous use. FDA-approved devices are already on the market to isolate stem cells for orthopedic and cosmetic therapies.
The Reality: While embryonic stem cells are used for research, they are not typically used in therapies due to ethical concerns and the risk of immune rejection. Most modern regenerative therapies use Adult Stem Cells, such as mesochymal stem cells, which can be harvested directly from your own bone marrow or adipose tissue. Using your own cells eliminates the need to harvest from embryos.
The Reality: Rejection and "graft vs. host disease" are primarily risks associated with donor stem cells. When you use your own (autologous) cells, the immune system is highly unlikely to attack them, especially if they are used to perform the cell’s normal biological functions.
The Reality: All medical procedures have risks, but stem cell therapy is not inherently more dangerous than surgery and may be safer when using your own cells. The risk of infection is small because treatments usually only require an injection, and the risk of tumor formation is minute if the cells are not overly manipulated or cultured for too long. Extensive data from over 750 Phase III clinical trials since 2020 increasingly demonstrate these treatments are both safe and effective.
The Reality: Stem cell treatments are minimally invasive outpatient procedures. While traditional surgery for conditions like Osteoarthritis might require hospital stays and physical therapy, stem cell injections allow for much faster recovery. Patients often report improved range of motion and decreased pain in as little as three months following an injection.
As regenerative medicine continues to evolve, the ability to access your own youngest, most potent cells becomes a vital component of a proactive health strategy. We believe banking your stem cells today is the single most important action that you can take to preserve your long-term health.
At Forever Labs, we provide the onramp to this future as the first ISO-certified biobank in the U.S. with the largest provider network and two U.S. patents. By preserving your body’s regenerative capabilities today, you ensure that as the science of longevity advances, you have the biological resources necessary to own your years.
Curious to learn more? Book your free 15-minute consultation today.
Sources
- Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use; Guidance for Industry and Food and Drug Administration Staff, (fda.gov)
- Introduction to stem cells and regenerative medicine - PubMed (nih.gov)
- Risk factors in the development of stem cell therapy (nih.gov)
- ClinicalTrials.gov
- Regulatory Considerations for Human Cells, Tissues, and Cellular and Tissue-Based Products: Minimal Manipulation and Homologous Use; Guidance for Industry and Food and Drug Administration Staff, (fda.gov)
- Regeneration of meniscus cartilage in a knee treated with percutaneously implanted autologous mesenchymal stem cells - PubMed (nih.gov)
