Singapore Cordlife probe: About 5,300 cord blood units deemed to be 'non-viable', says MOH

[The_King]

SINGAPORE: About 5,300 cord blood units stored in a second Cordlife tank and a dry shipper have been deemed "non-viable", the Ministry of Health (MOH) said on Monday (Apr 8).

This is on top of the roughly 2,200 cord blood units that were damaged in the first tank, affecting at least 2,150 clients.

 

 

Cordlife has been under scrutiny after it was revealed in November last year that seven of its 22 storage tanks were exposed to temperatures above -150 degrees Celsius, the acceptable limit for cord blood units.

Besides the damaged cord blood units in the first tank, MOH had directed Cordlife to conduct further testing of six of the affected storage tanks and a dry shipper, which is intended for transport and not for long-term storage.

"The results of the further investigations, which have been reviewed by MOH and its panel of experts, revealed that cryopreserved cord blood units stored in one of the storage tanks (Tank B) and the dry shipper are at high risk of adverse impact due to temperature warming events," said MOH on Monday.

"Hence an estimated 5,300 CBUs from Tank B and the dry shipper are deemed non-viable as they are unlikely to be suitable for stem cell transplant purposes."

The remaining five tanks have been assessed to be at low risk, the ministry said.

 

 

However, it recommended that Cordlife test a larger number of cord blood units in these five tanks "to obtain a more statistically significant result and further ascertain the status of the cord blood units stored in these tanks".

Seven people have been arrested in connection with the case, including former Group CEO Tan Poh Lan.

 

HOW TESTS WERE CONDUCTED 

Although the definitive way to conclude the viability of the cord blood units is to individually test all the units in the affected tanks, MOH said this was not practical as it would take "many years, even decades" to complete all the tests.

Sample testing was therefore conducted through a third-party laboratory.

“This will provide a preliminary, but meaningful, indication if the warming events had impacted the CBUs stored in these tanks,” said MOH.

 

 

Eight out of 12 samples from the second tank, Tank B, failed the tests, as did five out of 12 samples from the dry shipper.

"The root cause analysis indicated that there was insufficient liquid nitrogen maintained in Tank B, which had not been rectified due to failure of Cordlife’s staff to act on and escalate the anomalies. The dry shipper had also not been adequately monitored," MOH said.

"Given these findings, about 5,300 CBUs in Tank B and the dry shipper are not likely to be suitable for stem-cell transplant purposes and will have to be deemed as non-viable."

REFUND OF FEES

The Health Ministry has instructed Cordlife to inform its affected clients if their cord blood units fall under Tank B or the dry shipper.

Cordlife said that for the high-risk tanks, it will offer a refund of annual fees "received from the start of the temperature excursion". It will also waive future storage fees for clients until their child turns 21 while continuing to store the cord blood.

 

 

"At the same time, Cordlife Singapore will honour its commitment to find a suitable CBU if, in the opinion of the transplant physician, it is subsequently determined that their child's CBU cannot be successfully used solely because it does not meet the viability criteria when an approved cord blood transplant is required," the company added. 

In a bourse filing on Monday evening, Cordlife said it estimates that the refund and waiver of annual fees for all affected active clients would result in a fall in revenue and profit before tax of approximately S$9.2 million (US$6.8 million).

This would have an adverse impact on the financial results of the Group for the financial year ending Dec 31, 2024.  

 

FURTHER TESTS ON FIVE "LOW-RISK" TANKS

The five storage tanks that were deemed low-risk store about 14,000 cord blood units.

All 30 samples from across the five tanks passed the viability and potency tests conducted by an independent third-party lab, said MOH.

The increased temperature in four of the five tanks - tanks D to G - was likely due to misplaced temperature probes during scheduled maintenance, or incorrect mapping of the temperature probe to the tank.

For Tank C, the duration of exposure to the highest temperature of -144.7 degrees Celsius might not have caused damage to the cord blood units, said the ministry.

MOH experts have recommended that Cordlife test a large number of cord blood units in these five tanks to achieve more statistically significant results – 99 per cent of the samples tested must pass both potency and viability tests.

Cordlife has agreed to test more than 200 more samples across the five tanks and will review the outcome of the test results with MOH experts.

"As the tests, which involve complex processes, have to be carefully carried out, Cordlife expects to take approximately another year to complete the tests," said the ministry.

Cordlife has also been told to inform its affected clients if their units are in the five tanks that have a low risk of being affected, but are awaiting further tests.

"Affected clients of Cordlife are advised to be patient and await these results before making any decisions, including the transfer of cord blood units to another cord blood bank, given that there are significant risks involved in the transfer of cord blood units," said MOH.

"MOH will continue to closely supervise Cordlife’s rectification of the weaknesses identified in their governance structure, processes, systems and documentation."

Source: CNA/mi(gs)