The International Society for Cell and Gene Therapy (ISCT) has formed a consortium to tackle what it says is a rising number of unscrupulous and unproven cell banking players.

With the rise of interest in the cell and gene therapy sector, industry and the market have been plagued with unproven products and services from rogue actors looking to profit from ill-informed and sometimes desperate patients.

The US Food and Drug Administration (FDA) laid down a framework to tackle unapproved stem cell clinics, for example, and has issued warning lettersseized products and instigated legal action to crack down on unscrupulous actors who often co-opt scientific terms and offer tokens of scientific legitimacy without backing from scientific studies and clinical evidence.

“Beyond ‘stem cell’ clinics deceiving patients, with the approval of more cell and gene therapies, we see these profiteers moving to cell banking marketed to healthy people as well as patients,” Laertis Ikonomou, co-chair off the International Society for Cell and Gene Therapy Presidential Task Force (PTF) on the Use of Unproven Cellular Therapies, told Bioprocess Insider.

“There is potential for abuse in that the banking services may refer to direct-to-consumer unproven and unethical cell-based interventions will use cells from such cell banks. With global marketing and point of service kits, this is a borderless problem for all.”

Scientific consortium

As such, the ISCT has formed a global consortium of professional and education societies to help combat the rise in the number of unproven commercial cell banking services. The consortium includes: The International Society for Stem Cell Research (ISSCR), Society for Immunotherapy of Cancer (SITC), American Society for Transplantation and Cellular Therapy (ASTCT), American Society of Gene & Cell Therapy (ASGCT), European Society for Blood and Marrow Transplantation (EBMT), Foundation for the Accreditation of Cellular Therapy (FACT), Joint Accreditation Committee ISCT-EBMT (JACIE) and the Forum for Innovative Regenerative Medicine (FIRM).

Cell therapy preservation services“We do not currently have detailed statistics specifically on the number of cell banking services per region. It appears most are concentrated in the US, United Kingdom, and India,” said Laertis Ikonomou.“Nevertheless, we consider such services to be part of a global market for unproven cellular therapies. This market has been estimated to be worth as much as $2.4 billion (€2.13 billion). It is also estimated that currently approximately 60,000 patients every year globally are treated with unproven cellular therapies and charges for individual treatments can be as much as $40,000 (€35,500) per treatment.

The initiative looks to protect legitimate cell-based product development and patients in various ways, Ikonomou said.

“Any questionable offer of unproven cell-based products and services hurts the field of regenerative medicine. It erodes the public’s trust and it gives the false impression that it is acceptable to offer products that have not been proven safe and effective.

“Our collaborative effort aims to highlight these issues. We also want to demonstrate to patients the gap between the real clinical potential of such a service – which is unclear at the moment – and the overblown advertising claims of businesses offering commercial cell banking services.”

While industry-led efforts such as this are necessary, he added increased regulatory enforcement – such as the FDA’s recent injunctions against unproven tissue-based clinics – can rein in businesses that offer questionable cell-related services or products.

“Exaggerated and misleading claims of future clinical use for banked cells may also fall under the purview of the US Federal Trade Commission. ISCT is in ongoing communication with regulatory and professional societies around the world, through the ISCT led Cell Therapy Liaison Meetings with FDA, Health Canada, and additional channels.”

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