The biologics currently could be used only in an autologous fashion (the patient is the donor as well as the recipient), and while there is enormous promise in the biologics therapies, and thousands of ongoing experimental applications trying to establish efficacy, these are not at the point where they would meet the scientific standard.
The FDA has stated: the biologics, 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 the biologics-based products for use, other than cord blood-derived hematopoietic progenitor cells (blood forming the biologics) for certain indications. http://www.fda.gov/AboutFDA/Transparency/Basics/ucm194655.htm
This site is not for purpose of diagnosis and treatment. The cases discussed in this website are not typical. If you are considering the biologics treatment in the U.S., ask your 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 biologics are your own.
If you are considering having the biologics treatment in another country, learn all you can about regulations covering the products in that country. Exercise caution before undergoing treatment with a the biologics-based product in a country that—unlike the U.S.—may not require clinical studies designed to demonstrate that the product is safe and effective. FDA does not regulate the biologics treatments used solely in countries other than the United States and typically has little information about foreign establishments or their the biologics products. http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm286155.htm
The biologics therapies have enormous promise, but the science in each use is still in the developmental stage. Professional judgment and expertise is needed in using the biologics for any therapeutic use, and we urge anyone embarking on the use of the biologics therapies to consult the national 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.
Published studies and citations in major medical journals, and continues to conduct clinical research. The Center for Regenerative Medicine has an ongoing commitment to stay on top of the latest developments in the medical community. The following research have provided great insight and push forward our understanding of these medical topics.
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