Speculative cell banking services for future disease treatment are ethically problematic, according to a recent statement from members of the International Society for Cell & Gene Therapy (ISCT) Committee on the Ethics of Cell and Gene Therapy.1 “Businesses continue to make vague claims despite lack of support by scientific evidence,” says Laertis Ikonomou, PhD, one of the paper’s authors.
Ikonomou and colleagues were motivated by the authors of a 2021 paper who asserted chimeric antigen receptor T-cell (CAR-T) products can be derived from frozen blood samples.2 Those authors suggested the cells can be banked and used later. “We disagree with this, and we think it’s problematic, and that’s why we published the statement,” Ikonomou says. “When one reads the paper carefully, it’s clear what the limitations are. Our concern is that this paper serves as a token of scientific legitimacy and can be used as a tool to market problematic cell banking services.”
These ethical concerns are long-standing.3,4 Several years ago, the motivation was the emergence of cell banks offering banking of CAR-T cells. “This issue is not limited to the CAR-T space,” Ikonomou notes. “There are a lot of so-called dental stem cell banks that have offered similar services for many years.”
The common thread is the businesses are offering a service that is highly speculative, without a clear path to clinical translation. The 2022 statement expressing similar concerns “is the latest episode in this saga,” Ikonomou says.
It is possible further research will reveal CAR-T cells derived from cryopreserved blood can be used later. “But it is premature to offer this service now. That is the reality,” Ikonomou says.
The central ethical concern is the disconnect between clinical reality and what is marketed to patients. This mirrors the situation of unproven “stem cell” interventions offered to patients under the guise of research. “We see similar misleading claims here,” Ikonomou says. “Most marketed interventions are not even real stem cell interventions.”
Ikonomou and colleagues also objected to the emotional language used in marketing, such as statements urging parents to save their children’s future, or phrases such as “biological insurance.”
“This puts undue pressure to people to store their cells, without a clear path to clinical translation,” Ikonomou explains.
Clinicians are facing questions from some patients about speculative cell banking. Ikonomou and colleagues intended their paper to be a resource to prepare clinicians in all fields to discuss the limitations of gene cell therapy with their patients. They also hope they have created a resource for the general public.
“We did not develop the resource to be preaching to the choir. Stem cell and gene therapy developers already know what is feasible and what is not,” Ikonomou notes.
Ikonomou views the issue as similar to businesses offering storage of umbilical cord blood in private banks, despite the low possibility of it ever being useful to the individual paying for the storage. More broadly, some people are placing much trust in businesses that conduct direct-to-consumer marketing of unproven cell-based interventions.
“Some people are very suspicious of academics and clinicians, viewing them as the establishment elite with conflicts of interest,” Ikonomou notes. “What they don’t understand is that these clinics themselves have a huge conflict of interest.”
The clinics are not going to undermine their own business model by offering clear and objective information and acknowledging their limitations. “There is a blind spot there,” Ikonomou observes.
Steven Peckman, deputy director of the UCLA Broad Stem Cell Research Center, agrees: “If the purpose of commerc banking of cells is the thought that they may be useful for some type of individual therapy or disease, it is not supported by scientific evidence.”
Thus, any promises clinics make suggesting cell banking will be useful for the person paying the storage fees (or their family) are ethically troublesome.
“There seems to be an absence of evidence that the cells they preserve today will actually be appropriate for clinical use in the future,” Peckman says.
That is in part due to questions over how well the banks adhere to scientific standards for storage, and whether quality assurance is conducted appropriately. “Fundamentally, the issue comes down to respect for the patients. All ethical principles related to the biomedical field essentially begin with the idea that the individual patient should be respected,” Peckman says. “Part of that deals with upholding the autonomy of the patient, and providing the patient with sufficient information to make a knowledgeable decision.”
The problem is patients are receiving misleading information. Another issue is an individual’s judgment likely is clouded. A patient with severe pain from osteoarthrosis that limits their mobility may want to avoid surgery. Perhaps he or she hears it possible to bank some blood cells, take an injection, and cure the debilitating pain. In that situation, some people lose the ability to evaluate information critically.
“When people are sick, fearful of getting sick, or have a loved one who is sick, what’s their ability to evaluate information and make decisions that are in their own best interest?” Peckman asks.
It also is unclear whether after long-term storage, the cells would have any utility — not only for specific diseases, but even for reprogramming — at a point when the cells are needed by the individual paying the banking fees. When patients ask Peckman about stem cell storage for personal use, he cautions that it is not supported by scientific evidence. He encourages storing stem cells in research banks as a way to help people in the future.
Some research banks are disease-specific, allowing people to try to help others who are concerned about a specific disease, such as cystic fibrosis or amyotrophic lateral sclerosis. “I tell them that the stem cells will have far more utility used by legitimate scientists in the pursuit of developing treatments and cures than they will being stored in for-profit banks for unknown future clinical use,” Peckman says.
REFERENCES
- Levine BL, Munsie M, Levine AD, et al. The peril of the promise of speculative cell banking: Statement from the ISCT Committee on the Ethics of Cell and Gene Therapy. Cytotherapy 2022; Feb 19:S1465-3249(22)00025-1. doi: 10.1016/j.jcyt.2022.01.007. [Online ahead of print].
- Palen K, Zurko J, Johnson BD, et al. Manufacturing chimeric antigen receptor T cells from cryopreserved peripheral blood cells: Time for a collect-and-freeze model? Cytotherapy 2021;23:985-990.
- ISCT statement of concern regarding speculative commercial cell banking services.
- Ikonomou L, Levine AD, Hematti P, et al. Cell banking for cell and gene therapy: Regulatory, ethical and scientific considerations. BioProcess International 2020;18.
Clinicians are facing questions from some patients about speculative cell banking. Researchers recently published a paper intended to be a resource to prepare clinicians in all fields to discuss the limitations of gene cell therapy with their patients. They also hope they have created a resource for the general public.
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