USA FDA Data and Disclaimer

AmericaOne Cell Therapy works exclusively with premier USA based Cord Blood Providers that abide by FDA (Food & Drug Administration) compliant rules and processes. Stem Cell products are regulated by the FDA and generally all Stem cell products require FDA approval. Currently, the only Stem Cell products that are FDA approved for use in the United States consist of blood-forming Stem cells (also known as HSC or Hematopoietic Stem Cells) that are derived from umbilical cord blood. This material is approved for use in patients with disorders. See hotlink to HSC definition page herein that affect the production of blood (i.e., “hematopoietic” system)

Cord Blood Providers

The FDA has also stated:

Stem cells, like other medical products that are intended to treat, cure or prevent disease, generally require FDA approval before they can be marketed. FDA has NOT approved any stem cell-based products for use, other than cord blood-derived hematopoietic progenitor cells (blood forming stem cells) for certain indications.

*America One Cell Therapy’s’ website site is intended for licensed medical professionals and NOT intended for consumers:

If you are considering stem cell treatment in the USA, ask your Licensed Physician if the necessary FDA approval has been obtained or if you will be part of an FDA-regulated clinical study. This also applies if the stem cells are your own. Even if the cells are yours, there are safety risks, including risks introduced when the cells are manipulated after removal. There is a potential safety risk when you put cells in an area where they are not performing the same biological function as they were when in their original location in the body.” Cells in a different environment may multiply or may leave the site you put them in and migrate somewhere else.

If you are considering having stem cell treatment in another country, learn all you can about regulations covering the products in that country. Exercise caution before undergoing treatment with a stem cell-based product in a country that, unlike the USA, may not require clinical studies designed to demonstrate that the product is safe and effective. FDA does not regulate stem cell treatments used solely in countries other than the United States of America and typically has little information about foreign establishments or their stem cell products.

Stem cell therapies have enormous promise, but the science in each use is still in the developmental stage. Professional Licensed medical professional judgment and expertise is needed in using stem cells for any therapeutic use, and we urge anyone embarking on the use of stem cell therapies to consult registered health data bases to evaluate current information from clinical trials and the FDA websites on human tissue should also be consulted to get its current evaluation of any therapy.

http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm286155.htm