FDA warns companies against serious and unapproved stem cell treatments

After having sent to the hospital people who had been exposed to health problems related to unapproved stem cell treatments, the US Food and Drug Administration (FDA) published them. "FDA" A strict warning about these products.

"The messages we send today to manufacturers, health care providers and clinics across the country point out that there is a clear gap between stem cell products and practices and controls. important regulatory requirements for patient protection, "said Dr. Scott Gottlieb, Director of the FDA's Department of Drugs and New Products. "He said.

Stem cell treatments are called cell-based regenerative medicine because they have the potential to generate any type of cell. These treatments have long been marketed as a cure for all diseases. Hundreds of clinics promoting untreated drugs across the United States.

The US Food and Drug Administration has stated that poor monitoring has resulted in serious injury in some patients and has not been helped by these treatments.

In a report released Thursday, researchers at US Centers for Disease Control and Prevention said "CDC" Twelve of the patients who underwent stem cell therapy were so infected that they had to be hospitalized, but none of them died.

Between February and September 2018, these patients sought to treat various conditions, including chronic pain, joint or back pain, rheumatoid arthritis or osteoarthritis and round cuff tears, but life-threatening infections. , as E. coli Or enterococcus Quickly appear in the patient's joints or bloodstream. However, the source of injuries reported in the new report seems to be the point of manufacture, not the clinics themselves.

The CDC researchers stated that none of the stem cell products had been approved by the FDA or marketed legally.

Researchers at the Centers for Disease Control (CDC) have pointed out that umbilical cord blood, used as a source of cultured stem cells, is difficult to sterilize.

Perkins noted that "umbilical cord blood can not be removed after collection because there is currently no approved sterilization process, so production of highly derived products must be controlled to prevent the distribution of contaminated products ".