Unauthorized cord blood treatments

The recent arrests over alleged unauthorized stem cell therapies using blood collected from umbilical cords and placentas has shed light on the shady aspects of these expensive treatments provided by some clinics outside the coverage of public health insurance. The police should expose the entire picture of the case by delving into the many related problems. The Health, Labor and Welfare Ministry should meanwhile look into the operation of private cord blood banks — of which one reportedly provided the materials used in the unauthorized therapies — and establish some much-needed rules for their operations.

Cord blood contains blood-forming stem cells and constitutes part of materials that can be used for regenerative medicine. Cord blood is widely administered in treating blood diseases such as leukemia. The arrests marked the first case since the law to secure the safety of regenerative medicine took effect in 2014. The six suspects allegedly violated the rule requiring medical institutions that administer cord blood for their patients to submit treatment plans in advance for safety review by the health ministry — except when it is used on patients of 27 designated diseases, including leukemia, for which effectiveness of the treatment has been established.

The suspects include the president of a cord blood dealer in Tsukuba, Ibaraki Prefecture, a former chief of another firm in Fukuoka, and the heads of clinics in Kyoto and Tokyo. The cord blood used in the therapies in question was originally kept by a private cord blood bank in Ibaraki, which was transferred to the Tsukuba dealer after the bank went bankrupt in 2009. The dealer reportedly sold the materials to the Fukuoka firm and the Kyoto clinic, from which they were distributed to medical facilities across Japan.

Investigators have found that the cord blood was administered to more than 300 people at facilities in about 30 prefectures. About 30 percent of the patients are believed to be non-Japanese — mainly Chinese. Each treatment reportedly cost ¥3 million to ¥4 million. The police suspect that while most of the treatments were among the categories that must be reported in advance to the health ministry for review, such as cosmetic therapies and treatment for certain types of cancer, the doctors failed to do so. The effectiveness and safety of such therapies are unproven.

The head of the Tokyo clinic is suspected of altering his medical reports to make it appear that the cord blood was administered to patients of the 27 designated diseases for which advance reporting is not required, even though he was using the material for anti-aging and other treatments. Improper handling of the cord blood is also suspected. The former president of the Fukuoka firm allegedly thawed the frozen cord blood by pouring hot water on the container — which would have altered the quality of the material. There are suspicions that the Kyoto clinic administered cord blood that was not compatible with its patients.

Government-licensed public cord blood banks store cord blood voluntarily provided after childbirth in frozen state to be administered to third-party patients of blood diseases. The number of treatments using such cord blood has topped 10,000 since they were launched in 1999. Such institutions are required to follow standards on the condition of the cord blood they store.

Meanwhile, private cord blood banks, whose operation does not need a license, freeze and store the cord blood of newborns for a fee — around ¥200,000 — for possible use in treating the babies themselves and their relatives in future diseases. However, there are reportedly very few cases in which the cord blood thus stored was used for the intended purpose. These institutions are not bound by regulations that control public cord blood banks, and no rules are in place on what to do with the materials when the operators go bankrupt. Improper storage of cord blood could harm recipients. The health ministry should look into the operation of private cord blood banks and establish necessary rules to regulate their operations.

One factor behind the popularity of medical treatments using cord blood provided outside the health insurance coverage — even though their effectiveness and safety remain unproven — is believed to be the lack of regulations on online advertisements for medical services that tout such benefits as anti-aging and skin-beautification without providing scientific proof. The health ministry should take necessary action even before an amendment to the Medical Treatment Law, which seeks to regulate such online ads, takes effect by next June. Consumers should also be on their guard when deciding whether the treatment they’re seeking is really worth the cost.