The Food and Drug Administration recommends that people who consider getting a stem cell treatment need to make sure it has been approved or is being studied in a clinical trial that federal health regulators have allowed. The kind that have generated the most excitement - and controversy - are human embryonic stem cells, which are derived from early human embryos and can be coaxed to become any kind of cell in the body. After 20 years of research, Italian scientists recently received European regulatory approval for a stem cell-based treatment for a type of blindness that results from damage to the cornea, the surface of the eye. The fat tissue was then processed with enzymes with the goal of obtaining stem cells.

However, they immediately suffered complications, including retinal detachment and hemorrhage, which caused total loss of eyesight. "It's just not the case".

None of the women are named in the study.

In 2013, the company listed a trial on ClinicalTrials.gov titled, "Study to Assess the Safety and Effects of Cells Injected Intravitreal in Dry Macular Degeneration", according to the ClinicalTrials.gov site. Both lawsuits were settled, with the women receiving payments.

He warned that patients could be misled by "rogue clinics" which failed to distinguish between the many different types of stem cell. Those efforts have stalled, however. She stated that this was not a drug it was a simple procedure. Albini says the complications could have come from injecting a contaminant into the eye, or from the fact that the stem cells may have turned into myofibroblasts after the injections, which are cells associated with scarring.

The cases show that patients need to be warned that something that "sounds too good to be true may indeed be too good to be true and may even be disgusting", Albini says.

The company appeared to have plans to do more such procedures. Small molecule inhibitors for cancer stem cells in this study are available or being utilized in clinical trials for other diseases. The two women told Albini that they did not recall signing documents other than the single page form.

"Patients and physicians in the United States should be made aware that not all "stem cell" clinics are safe, and that "stem therapy" as provided in private clinics in the U.S. is unproven and potentially harmful", says Thomas Albini at the University of Miami's Bascom Palmer Eye Institute, Florida, who subsequently treated two of the women.

Each woman paid $5,000 for the procedure.

The doctors say patients should also check if anything purporting to be a clinical trial is affiliated with an academic medical centre and inform themselves about stem cell treatments.

"These women had fairly functional vision prior to the procedure. and were blinded by the next day", said ophthalmologist Dr Thomas Albini of the University of Miami, whose team examined the women after their treatment at a clinic in Florida. In the case of the eye injections, the clinic injected both eyes at once, which is highly unusual and unsafe for an experimental treatment.

The trial was not preceded by laboratory experiments and lacked comparison between treated patients and "control group" participants given a dummy therapy.

It's still not clear what went wrong, but the report says the treatment raised several red flags from the beginning.

But even if executed correctly, there is no evidence suggesting that the procedure could help restore vision, Goldberg and Albini said. A year later, the patient suffered none of the additional vision loss that would be common with the condition. iPS stem cells have a body of research behind their potential healing abilities, while the fat-based cells used in the procedures do not. It offers stem cell treatments for a variety of diseases and injuries, according to the company's website.

"With this new and exciting study, Dr. Wang and his team have provided the building blocks for understanding the cellular and genetic mechanisms behind squamous cell carcinoma", said Dr. Paul Krebsbach, dean of the UCLA School of Dentistry. "Doing the procedure in rats might have shown whether there are safety problems".

Without regulation of stem cell isolation and delivery processes at stem cell clinics, it's hard to know whether their cocktails contain harmful chemicals leftover from the isolation process - or whether they contain stem cells at all. In a regulatory filing, it reported that its techniques can treat chronic obstructive pulmonary disease, hip and knee conditions, diabetes, multiple sclerosis, Parkinson's disease, autism, colitis, and lupus.

Excerpt from:
Unproven Stem Cell Treatment Blinds 3 Florida Women - ClickLancashire