Patients frequently ask if they can get stem cell treatment for their arthritis or rotator cuff tears. Some even ask if stem cells are legal in America or do they have to go overseas?
So, we must explain what stem cells are:
Stem cells are cells with the ability to differentiate into various cell types in the body and regenerate damaged or diseased tissue. Yes, stem cells are used in the US for medical purposes such as in the treatment of cancer, blood disorders, and certain diseases affecting the bone, skin, and cartilage. , The use of stem cells is regulated by the US Food and Drug Administration (FDA) though some stem cell treatments remain controversial and may not have been scientifically proven to be safe and effective.
What is FDA stance on stem cells?
FDA regulates human cells, tissues, and cellular and tissue-based products (HCT/Ps), including stem cells, under the authority of the Public Health Service Act and the FDA’s implementing regulations. The FDA’s regulation of HCT/Ps is intended to protect patients from unsafe or ineffective products and to ensure that the products meet appropriate standards for quality, purity, and potency. According to the FDA, stem cell treatments should be studied in clinical trials to determine their safety and effectiveness before being made available to patients. The FDA has issued warning letters to companies marketing stem cell products that have not been proven safe and effective and has acted against some companies for making false or misleading claims about their products.
What stem cells are legal in the US?
The FDA has approved the use of some stem cell treatments for specific medical conditions, such as blood disorders. It’s important to note that not all stem cell treatments have been scientifically proven to be safe and effective, and some may be illegal or considered off-label use by the FDA. Some of the stem cell treatments that are currently being studied or used in the United States include:
- Autologous stem cells (ACST) that are taken from the patient’s own body and then processed and returned to the same patient.
- Hematopoietic stem cell transplantation (HSCT) for blood disorders such as leukemia and lymphoma
- Mesenchymal stem cell (MSC) therapy for conditions such as osteoarthritis and Crohn’s disease
- Induced pluripotent stem cell (iPSC) therapy for diseases such as Parkinson’s and sickle cell anemia
- Cord blood stem cell therapy for certain types of cancer and blood disorders
- Regenerative medicine uses stem cells to repair or replace damaged tissue, such as heart muscle cells, skin cells, and cartilage cells
Patients considering stem cell treatments should discuss the risks and benefits with their healthcare provider and verify that the treatment is being provided by a licensed and reputable medical professional.
What stem cells are illegal in the US?
FDA has clearly stated that the use of Stromal Vascular Fraction (SVF), amniotic tissue, or exosomes are all obtained by more than minimal manipulation. To use any of these products they need to go through the formality IND study which must be approved by the FDA.
U.S. Food and Drug Administration (FDA) and National Institutes of Health (NIH). You can find more information about stem cell treatments and the FDA’s stance on them by visiting the FDA website at www.fda.gov and searching for “stem cells.” The NIH also provides information on stem cell research and clinical trials on its website at www.nih.gov. Additionally, you can find some of the studies and clinical trials on the website of the National Library of Medicine at www.pubmed.gov.
If you’re interested in learning more about stem cells and how it can benefit you, please give ROSM a call at (202) 681-7671 or visit our contact page for more information. At ROSM, we offer a variety of treatments to help as many patients as possible achieve the healthy and sustaining outcomes they deserve.
