Because of the 60 Minute Television program exposing fraud in the marketing of Stem Cells last Sunday, I feel it necessary to preempt the previously announced blog for this week with a word or more of caution. Sometimes called the body’s “master cells,” stem cells are the precursor cells that develop into blood, brain, bones and all of your organs. When used as a medical treatment, there is the potential to repair, restore, replace and regenerate cells and thereby treat many medical conditions and diseases including arthritis.
But the Food and Drug Administration (FDA) is concerned that the hope, which patients have for cures not yet available, may leave them vulnerable to unscrupulous providers of stem cell treatments that are illegal and potentially harmful. Witness the Sunday night episode of 60 Minutes.
FDA cautions consumers to make sure that any stem cell treatment they are considering has been approved by FDA or is being studied under a clinical investigation that has been submitted to and allowed to proceed by FDA.
Regulation of Stem Cells
FDA regulates stem cells in the U.S. to ensure that they are safe and effective for their intended use.
Stem Cells that come from bone marrow or blood are routinely used in transplant procedures to treat patients with cancer and other disorders of the blood and immune system.
Why my Pilot Study and then Clinical Trial? As part of these studies, I must show how the product will be harvested and prepared so that FDA can make certain appropriate steps are being taken to help assure the product’s safety, purity and potency.
Consumers need to be aware that at present—other than cord blood for certain specified indications—there are no approved stem cell products.
Advice for Consumers
- If you are considering stem cell 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 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, form tumors, 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 U.S.—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 and typically has little information about foreign establishments or their stem cell products. China has recently announced a governmental mandated regulation of a prior free for all in the stem cell market.
- To reemphasize my approach to realizing the promise of stem cell management of arthritis; treatment at the Regenerative Pain Center will only be offered via Pilot Study or Clinical Trial under FDA governance and IRB regulation. Your cells will be harvested from your own bone marrow, concentrated, and administered to your arthritic joint.
Mitchell B. Sheinkop, M.D.
1565 N. LaSalle Street
Chicago, Illinois 60610