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Court rules in FDA’s favor against stem cell clinic

July 8, 2019

A federal court has agreed with the Food and Drug Administration that a Florida clinic adulterated and misbranded a stem cell drug product made from a patient’s fat tissue.

The summary judgment against US Stem Cell Clinic, US Stem Cell and the company’s chief medical officer affirms the FDA’s regenerative medicine policy and its risk-based approach to the enforcement of cell-based products. US Stem Cell has agreed for now to stop producing and administering treatments from adipose tissue.

The FDA also has sought a permanent injunction against a California-based company, seeking to stop it from selling unapproved cellular therapy products.

Frequent blood donations may reduce heart disease risk for women

July 1, 2019

Women who donate blood regularly showed a reduction in risk factors for heart disease, a recent Dutch study showed in preliminary results.

No difference was noted for men. The results were published in the journal Blood.

The heart health benefit becomes another positive factor for making donating a habit.

“Doing something good like giving blood warms your heart emotionally, and now a study shows it may help your heart physically, too,” said Dr. Samantha Gomez Ngamsuntikul, Associate Medical Director at BioBridge Global.

Researchers in The Netherlands analyzed records from 159,934 whole blood donors who had been donating for at least 10 years. Data for donations and death from heart disease were acquired from Dutch hospitals and the country’s national personal records database.

Irma Villarreal looks back on 40 years

June 24, 2019

When the South Texas Regional Blood Bank moved from San Pedro Avenue to the old YWCA building in downtown San Antonio in 1984, the space for blood collections was limited, to say the least.

“We had four chairs and one TV,” recalled Irma Villarreal, who helped with the move five years after she started with the organization. “The machines were so loud we had to turn up the TV full blast. And then people would get upset because you could hear that TV all over the building.”

Other things have changed since Villarreal started with the organization as an HLA typing expert, including her job description. Currently, she is Director, BioBridge Global Quality & Compliance.

“Where do you start?” she replied when asked about all her job titles.

Grief shown to take a physical toll on survivors

June 17, 2019

Susan Smith has seen how the death of a loved one can lead to illness among survivors.

“Grief is as hard on the body as stress,” said Smith, the Grief Support and Life Legacies Manager at GenCure. “I have seen it more than a few times.”

Researchers at the University of Arizona went back and looked at studies about the “broken heart” effect, and then focused on 13 studies from the last 40 years. They recently published their findings, titled “A Systematic Review of the Association Between Bereavement and Biomarkers of Immune Function,” in the journal Psychosomatic Medicine

Data reports negative blood donation reactions are rare

June 10, 2019

Negative reactions when giving blood are extremely rare and usually not complicated, according to data compiled in the AABB Donor Hemovigilance report for 2012-17.

In 2017, just 2% of blood donors reported having some sort of a reaction during or following donations, said the report by the sanctioning organization for blood centers. Of those reactions, more than half were “prefainting,” a term for dizziness or light-headedness.

Dr. Rachel Beddard, Chief Medical Officer at BioBridge Global, said the results of the survey were not surprising. From educating donors about preparation, to asking specific questions before donation, to training of staff, the process is designed to make the process as painless as possible.

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