The Battle For Your Stem Cells: Researchers and academics say lust for money has corrupted Utah's burgeoning stem cell sector.

• Author: Penrod, Emma

To many mothers, the choice to donate their birthing tissues followed the same no-brainer logic as organ donation. "I just thought it was something that was going to be thrown away anyway," says Stephanie Denton, a donor who lives in Colorado. If something good could come of it instead, she says, why not?

Charlotte Beierle, from Cedar City, quickly came to the same conclusion when her St. George-area doctor introduced her to the idea. She'd always been an organ donor, she says, and "I feel like if I have something to give someone else that is going to help them out, I would want to do that."

Both mothers said donating through Utah-based Cellsure was an all-around positive experience. The company charged them nothing and even sent couriers to their homes to collect blood work and the donated material.

What became of their donations was unclear. Both Denton and Beierle say they believed Cellsure was a nonprofit organization that harvested stem cells from donated birthing materials for medical research or for the treatment of certain conditions. But neither was sure what kind of research, or where the cells would be used.

"That was one of my questions," Denton says. "Would they sell this tissue? And they said that the cost the families had was minimal."

Yet according to publicly available company records, Cellsure-actually a low-profit, rather than non-profit organization-is in fact a wholly owned subsidiary of Predictive Technology Group, a Salt Lake City-based company dedicated to developing new biopharmaceutical therapies that has come under fire for high-pressure, misleading sales tactics, and for skirting FDA drug regulations.

Predictive states that its products are "ethically sourced from donated birthing tissues, such as umbilical cords and placentas from full-term deliveries."

According to a July 2019 report by Hindenburg Research, the distributors that sell Predictive's products charge between $5,000 and $25,000 per treatment, promising miraculous results. In one conversation with Hindenburg founder Nathan Anderson, a sales associate with Cellsure claimed donated materials could be used to cure autism.

Predictive, however, is far from a one-off. Local and national scholars describe the emerging stem cell industry as rife with corruption, misleading advertising, and in some cases outright fraud and illegality. A University of Utah researcher with ties to stem cell startups suspects that pressure to turn fast profits has led some companies to take unnecessary risks, even at the expense of patients' safety and scientific integrity.

And regulators, ethicists say, have basically given companies in this arena a free pass to ignore federal drug regulations.

Pursuing profits at risk to patients

At least some of the companies taking fire for questionable business practices started out as scrupulous, research-backed ventures-and there is no shortage of stem cell research in Utah, according to Christof Westenfelder, a professor and medical doctor who heads the nephrology section at the University of Utah's George E. Wahlen Health Sciences Center.

Westenfelder's team has focused primarily on using stem cells to treat kidney and renal failure, and to develop a potential cure for Type 1 Diabetes. Other companies, he says, have worked on everything from degenerative spinal conditions to hair loss.

"Stem cell therapy is very popular in Utah ... there are lots of people interested in the field," Westenfelder says. The high level of interest among local researchers, he says, led to the creation of a stem cell interest group at the University of Utah, which is now in the process of establishing a multidisciplinary center for regenerative medicine.

There is also keen interest in commercializing these products.

"There are...