Stepping Up Enforcement Efforts On Stem Cell Therapies

The FDA has approved 4 hematopoietic progenitor cell products and approved cord blood derivatives including, HEMACORD, ALLOCORD, CLEVECORD, and Ducord. The only stem cell based products that are FDA approved for use within the USA consists of blood forming stem cells derived from cord blood, these products are approved for limited use in patients with disorders that the body system involved in production of blood.

There are also a diverse range of stem cell therapies being offered to patients in additional to these FDA approved therapies. Only 5 years ago there were only a few physicians offering a few services involving stem cell treatments, this has expanded exponentially over the past few years offering treatments involving stem cells derived from bone marrow, adipose tissue, peripheral blood; and cells derived from umbilical cord blood and tissue, placental blood and tissue, amniotic fluid and tissue, and more.

Assessing regulatory compliance of these medical centers falls under the purview of the U.S FDA, European EMA, Japanese PMDA, and other regulatory bodies around the world. Around the world doctors now routinely use stems cells from bone marrow or blood transplant procedures to treat cancer and disorders of the blood and immune system.

Stem cells have been called everything including providers of promise to the miracle cure alls. The FDA is warning consumers to beware of unscrupulous providers that are offering stem cell products which are unapproved and unproven; and potentially dangerous procedures suggesting to do your research and ensure that you are really getting what is being offered before considering any treatment.

There are concerns that some patients may be seeking out cures and remedies in a manner that leaves themselves vulnerable to unscrupulous stem cell treatments that are fake, illegal and may be potential harmful. When there is a demand for a product unscrupulous sources will always emerge trying to get as much money as they can to gain from it. The FDA will advance new framework and is increasing its oversight and enforcement to protect the public from such dishonest stem cell providers and clinics, while continuing to encourage development and innovation so the medical industry can properly harness the full potential of stem cell products.

Although work in the field shows great promise and has some wonderful results in studies it is still best to be cautious. If considering a treatment ask if the FDA has reviewed it, and ask if the healthcare provider has confirmed the information before getting treatment, even if the stem cells are your own. Ask for facts and ask questions if you don’t understand before you sign the consent form, and make sure that you understand the entire process and any known risks before you sign. Be sure you are dealing with a reputable provider/clinic, as they will be happy to answer all of your questions, and provide any information you ask for in detail.