Stem cells: US study reveals huge business unapproved by FDA

On June 30, 2016, the revue Cell Stem Cell published a study on the use of stem cells in the United States. It revealed that 570 U.S. clinics offer care based on using stem cells which are not authorized by the FDA.

In 61% of the procedures proposed by the clinics, the stem cells are derived from fatty tissue, and for 48% of the clinics, it comes from bone marrow. One per cent use pluripotent cells made in laboratory from adult cells and one clinic proposes embryonic stem cells. Therefore every year, tens of thousands of Americans are treated by stem cells that have not been officially approved by the FDA.

The clinics involved are spread out throughout almost every state of the U.S. “This business is exploding in front of our eyes and I don’t think we are aware of its extent or its size”, notes Leigh Turner, co-author and member of the Center for Bioethics at the University of Minnesota. Businesses are promoting these treatments, which are still experimental, for orthopedic conditions, spinal cord injuries, neurological disorders, and pulmonary problems as well as for cardiac diseases and even for cosmetic applications.

« This therapy is available in almost every state (…) so Americans no longer need to go to Mexico”, explained Paul Knoepfler, researcher at the University of California and principle co-author of the survey. He emphasizes: “This means there is a change regarding typical medical tourism for care using stem cells” compared to what was previously seen.

For the authors of the study, this phenomenon could have a negative impact: “Patients using this treatment with unapproved stem cells may experience negative side-effects, and the public may become distrustful”.  

The FDA specifies they will organize two public meetings in September on stem cells and human tissue as well as cell-and-tissue-based medical products and therapies.

Major and confirmed risks:

Regarding risks, the New England Journal of Medicine reported in the June 22 edition a dramatic case of a patient who was attracted by promises of being cured. At the age of 66, he was suffering residual deficits from an ischemic stroke. By visiting different commercial stem-cell clinics in China, Argentina and Mexico, he received infusions in the cerebrospinal fluid supposedly originating from embryonic and fetal neural stem cells. After these “treatments”, progressive lower back pain, paraplegia and urinary incontinence subsequently developed. Further analysis revealed he had developed an “unclassifiable” tumor which could not be assigned to any category of previously described tumors, from the foreign stem cells injected.

In a forum in the International Journal of Medicine, Dr. Anastasia Roublev specifies that this case “confirms the major risks that can be associated to the introduction of stem cells in the organism, risks especially related to the proliferation of these embryonic cells and thus the rapid appearance of mutations which could enhance malignant transformation”.