Stem cells have been on the forefront of exciting new research in recent years. However, it seems some clinics have gone too far in promising what stem cell treatments can offer. Of the more than 550 known stem cell clinics nationwide, a significant number offer relief for everything from sports injuries to autism to Alzheimer’s disease to multiple sclerosis. In reality, there is scant evidence these treatments offer any beneficial outcomes for these patients, and worse, in some cases the treatments may result in serious and life-altering harm.
Recently, The Washington Post reported on three incidents at a south Florida clinic that was offering unproven stem cell treatments as a “clinical trial.” Three female patients with visual impairment agreed to participate, in the hope the treatments might help improve their vision. Instead, it rendered them all three completely blind.
This was reported in a recent article in the New England Journal of Medicine, which outlines this as one of the most egregious instances of personal injury involving a stem cell. There are at least a handful of stem cell clinics here in North Carolina, including in Charlotte and Cary. The services of one were recently detailed in The Charlotte Observer, with the clinicians promising non-surgical relief for sports injuries and chronic joint pain. Stem cell injections were touted as a “regenerative” alternative to hip replacement or knee replacement surgery.
In the Florida case, the women involved reportedly believed they were participating in a study that was government-sanctioned. This belief stemmed from the fact that the clinic listed its study within the database on ClinicalTrials.gov, a site operated by the National Institutes of Health. The clinic reportedly did not address this misconception with patients prior to the treatments.
Soon after undergoing the treatments, the patients reportedly suffered hemorrhaging, detached retinas and vision loss. Study authors say it is imperative that patients and consumers understand that these clinics are not regulated in the same way as your doctor or surgeon. The clinics are not regulated by the U.S. Food & Drug Administration because they claim exemption under a provision that allows those who “minimally manipulate cells” to fly under the radar. The FDA recently released a “draft guidance” to clarify and tighten regulation, and is holding a public hearing on the operations in the fall.
The same clinic that provided these treatments still has several other ongoing “trials,” including one to treat degenerative disc disease and another for chronic obstructive pulmonary disease, the Post reported.
Two of the patients who suffered vision loss, both in their 70s, reportedly settled their personal injury claims out-of-court.
Commenting on the proliferation of these stem cells, stem cell researcher Paul Knoepfler, author of a new study Cell Stem Cell, told Scientific American that most cell therapies “don’t do much of anything,” and worse could result in life-threatening complications, such as immune system overreactions or blood clots.
The majority of these treatments involve fat stem cells. So a patient undergoes liposuction, the clinician chemically separates the stems cells from the fat cells and then the stem cells gleaned are injected into the patient’s injury site.
Contact the Carolina injury lawyers at the Lee Law Offices by calling 800-887-1965.
Unproved Stem Cell Clinics Proliferate in the U.S., June 30, 2016, By Dina Fine Maron, Scientific American
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