“If you’re a student and living on a $700 monthly budget, an extra $200 is a good fit,” Bernow says. “If you work 10 hours for me, I don’t mind paying $200. They should be paid more, but we are not allowed to do that and we respect all the rules.”
Many countries have rules that prevent people from being paid for donating their tissue. In the UK it is illegal to pay people to provide blood, plasma or other tissue, although donors can be reimbursed for expenses and loss of earnings. In Sweden, as in many other EU countries, donors can be compensated for their time, but cannot be paid.
“Should they be paid anything?” asks Hank Greely, a law professor at Stanford University who specializes in ethical and legal issues in the biosciences. “Depending on who you ask, it may or may not be a shame. But it is a venial sin, not a mortal one.” In the United States, people can get paid to donate sperm, eggs, and blood.
What might make stem cells different is the cost of the treatments. Bernow says each donation produces about 50 ml of tissue containing the mesenchymal stem cells used in his therapies. These cells are then purified and duplicated in the Cellcolab laboratory, ultimately resulting in approximately 200 therapeutic doses of stem cells per donation. Assuming each treatment costs $16,500, that means a single donation could be used for treatments worth more than $3 million. Bernow says he currently has between 15 and 20 donors a year.
Of course, cells are not the contributing factor to the cost of stem cell treatments. Bernow says that for a $25,000 intravenous treatment, about $10,000 of that cost goes toward managing the clinical trial and the remainder partially funds the cost of extracting, duplicating, storing and transporting the stem cells. The main goal of his startup, he emphasizes, is to reduce the need for donors and the cost of stem cells by producing more from each donation.
“This is a very simple economy of scale,” he says. “Our goal is to drastically reduce prices over the next decade. We want to find a radical change to be able to get more cells produced from a donor.”
For Greely, the biggest problem with stem cell therapies is the treatments themselves. “My main concern is effectiveness,” he says. The FDA has warned people about stem cell treatments that are not approved in the United States. “There is much misleading information on the Internet about these products, including statements about conditions they may be used to treat,” the agency warned in a 2020 post. “The FDA is concerned that many patients seeking treatments and remedies may be misled by information about illegally marketed products that have not been proven safe or effective and, in some cases, may have significant safety issues that put patients at risk.
As for donors being paid $200 for their contribution to treatments that end up costing millions of dollars, Greely is less troubled. “Welcome to capitalism.”
Updated 2-12-2024 14:00 GMT: The figure quoted in the headline has been changed from thousands to millions, to more accurately reflect the potential retail value of a single dose of donated stem cells.