Alberta couple raises contamination concerns as Health Canada cracks down on cord blood clinic

For Carly and Ben Seligman, banking their two children’s umbilical cord blood felt like investing in medical insurance.

The Calgary couple no longer trust that the potentially life-saving stem cells they have spent thousands of dollars to preserve remain viable or safe.

“Collecting and banking the cord blood felt like this sort of one-time opportunity to leave future medical doors open for your child,” Carly Seligman said in an interview.

“You want to try and give your child every opportunity.”

The Seligmans say they have spent more than $3,900 to store the umbilical cord blood of their two children, now 12 and nine years old, at the Canadian Cord Blood bioRepository (CCBR) in west Edmonton.

More than three months after Health Canada issued a public health warning about the facility, the regulator says the operation remains in contravention of health safety standards.

Issued in November, the public health advisory cautions that cord blood banked at the facility could pose serious health risks including the spread of infectious diseases and contamination.

Questions linger about the viability of hundreds of umbilical cord blood specimens as Health Canada continues to warn about unsafe and unsanitary conditions, nearly a year after a first inspection uncovered the operational issues.

Health Canada says the repository has failed to submit a corrective action plan, as ordered. The facility remains barred from accepting new specimens.

Cord blood from about 800 clients remains at the repository and the regulator says the specimens should be tested to ensure they are safe and viable before use in medical treatments.

Rich in stem cells, cord blood can be used to treat a variety of medical issues including blood and immune disorders. The specimens are kept sterile and frozen through cryopreservation.

The Canadian Cord Blood bioRepository, like all of Canada’s private cord blood banks, charges for the service of collecting and storing cord blood in case it is needed by the infant donor later in life.

‘Have our samples been contaminated?’

The facility charges around $900 in processing for each specimen, and roughly $110 per year after that in annual fees.

With another storage payment due, Carly Seligman is demanding more transparency from the operator. 

“Did their storage practices compromise the usability of our children’s cord blood?” she said. “Have our samples been contaminated?”

The clinic’s founder and CEO, Dr. John Akabutu, told CBC he could not comment on the enforcement on the advice of his lawyers.

In correspondence with the Seligmans, Akabutu maintains the facility is in compliance and was subjected to an inspection by Health Canada staff who were misinformed of the regulations.

Timothy Caulfield, a University of Alberta professor and a Canada Research Chair in health law and policy, said the ongoing lack of compliance is concerning. 

“It’s tremendously worrisome,” Caulfield said. “It’s a breach of trust and, of course, it brings into question the value of those cells in the future.”

Caulfield said Health Canada’s warning should send a message to cord blood repositories across the country. He said stronger enforcement is needed for the private, for-profit industry, especially around advertising.

Clinics often promote yet-to-be developed stem cell therapies and inflate the likelihood that such specimens will be needed by — or even useful to — donors in the future, he said.

Caulfield encouraged parents to donate instead to public cord banks. Public banks, which are free for donors and regulated by Health Canada, use their blood stores for research and to treat any patient who might require stem cell therapy.

He said specimens at private banks rarely become of use. If your baby were to need stem cells, the child would probably need them from someone else.

Consumers need to be wary of speculative medical claims made by private cord banks, he added.

“They leverage real science in order to sell a product,” he said. “Take care and scrutinize their claims very, very closely.

“Parents are in a vulnerable situation. Everyone wants to do what’s best for their kids.” 

The inspection 

The federal Food and Drugs Act regulates all cord blood banks but private banks are not subject to routine inspections.

Health Canada conducted its first site visit to CCBR on March 15, 2023, followed by an additional site visit on July 27.

Health Canada says its investigation began following a tip from a member of the public. Inspectors found the facility was processing, testing and storing blood in an environment that was “unclean or cleaned with expired disinfectants.”

The repository also had inadequate measures to monitor temperature, humidity and contamination during processing, testing and storage, Health Canada said. It also noted concerns about a lack of qualified personnel, uncalibrated equipment and poor record-keeping. 

“The department continues to monitor the CCBR to ensure they are not collecting, processing, testing and storing new cord blood,” Health Canada said in a statement to CBC on Feb. 9. 

“Should CCBR continue to operate and not adequately address Health Canada’s concerns, the department will take additional enforcement action.” 

The repository was also advertising that cord blood could be used by someone other than the donor, Health Canada said.

The facility is only permitted to store blood for autologous use, meaning a specimen can only be used by the person it came from.

“CCBR has confirmed to Health Canada they have not released cord blood for autologous use in Canada and has stopped registering new customers. This means there is no immediate risk to health for the general public.”

The department has not ordered the destruction of any blood specimens. Customers are encouraged to contact the company to understand their options, Health Canada said.

They need to demonstrate and prove that our samples haven’t been compromised.– Ben Seligman

The operator was ordered to inform all of its clients of the enforcement. The Seligmans said they found out from a news article.

Soon after, the couple received an invoice and wrote to the facility, asking how it would improve its safety standards. The response they received left them with more questions, said Ben Seligman.

“We were simply trying to understand what our options are,” he said, “and ultimately understand where things stand with the samples of our two kids.

“They need to demonstrate and prove that our samples haven’t been compromised.” 

In the responding email, Akabutu states that Health Canada incorrectly classified the facility as a drug producer and transplantation centre.

Akabutu alleged in the email that Health Canada inspectors were not knowledgeable and included misinformation in their reports. The facility is “not deficient” from a regulatory perspective, he wrote.

He states that none of the samples stored on site will be used for unmodified transplantation, and said he would consider those methods “yesterday’s medicine.” 

“The samples that we hold for you can be compared to gold ore from a gold mine,” he wrote to the Seligmans. “Gold ore requires refinement to produce gold bars, which is comparable to refining our samples.”

Health Canada declined to comment on Akabutu’s allegations about the inspection.

Heidi Elmoazzen, an expert on cord-blood banking, said the clinic’s claims cast doubt on how useful the samples could be for future treatments.

She said the vast majority of the currently approved medical therapies rely on unmodified transplantion, where the cells are used without any further medical manipulation, such as gene editing. 

“Cord blood is used to treat over 80 diseases and disorders. And the way they’re used right now is in an unmodified form,” said Elmoazzen, who has a PhD in medical sciences from the University of Alberta with a concentration in cryobiology. 

“I think a lot of families would expect that, as that is the most common use of cord blood, that they would be able to use these units for that purpose.”

Elmoazzen encouraged affected customers to demand answers about what the facility is doing to come into compliance.

“The cord blood bank should be able to notify the customers about what they’re doing to alleviate the concerns of the families. That’s what Health Canada has asked them to do.”

The Seligmans are unsure of what they will do with their children’s cord blood units. They fear their family has lost something irreplaceable.

“There is the financial cost but even more than that, you’re investing in something bigger,” Carly Seligman said. “Cord blood, it’s a one-time shot.”