[사회]Suspicion of ‘unauthorized freezing’, the world’s first stem cell treatment

[앵커]

YTN explores and reports on suspicions and controversies regarding Korea’s world’s first stem cell treatment four days from today.

In 2011, the Lee Myung-bak administration approved the use of a stem cell treatment for acute myocardial infarction called ‘AMI of the heartgram’.

However, the manufacturer was suspected of having frozen the patients’ stem cells without even obtaining permission while undergoing the treatment.

Reporter Kim Woong-rae from the Exploration and Planning Team reports.

[기자]

Hearti Cellgram AMI.

It is the first stem cell treatment for acute myocardial infarction in the world to be marketed with the approval of the product 9 years ago.

[이명박 / 전 대통령 : 우리나라도 최근 심근경색 치료제가 공식 허가를 받으면서 세계 최초로 줄기세포 치료제 상업화에 성공했습니다.]

HeartiCelgram AMI is made from mesenchymal stem cells obtained from the bone marrow of a patient with acute myocardial infarction.

The product was approved by the Ministry of Food and Drug Safety based on the fact that when administered to the heart, it partially restores the heart’s ability to pump blood throughout the body.

However, suspicions arose that the manufacturer, Phamicel, created a treatment by freezing and melting stem cells, contrary to the license.

[식약처 관계자 : 냉동 프로세스가 중간에 저희가 보았을 때는 없어 보이는데, 냉동에 대한 부분은 왜 여쭈시는 걸까요?]

This is a patient management record obtained by YTN.

It was written by a salesperson, and there are a lot of patients who took a remedy several years after freezing, the so-called “stem cell bank.”

[줄기세포 보관 영업 사원 : (냉동 보관한) 사람들은 언제든지 와서 맞으려고 하면 해줘야 돼요. 우리가 그렇게 (환자) 모집을 했고, 회사에서도 그렇게 지시를 했고….]

Some of the patients who went directly to the hospital without going through a vendor were also recommended to be frozen and administered.

[유병환 / 환자 보호자 : 거기(병원)에서는 그렇게 하라고 권유했던 거죠. 한 번 골수 채취해서 배양해서 세 번까지 주사를 맞을 수 있다고 들은 것으로 알고 있어요. (보관해 놨다가요?) 네네.]

Famicel said it was simply frozen bone marrow blood, which was only part of the manufacturing process.

This explains that there is no problem because it was a minimal operation that did not require a permit under the corresponding law.

However, the results were different.

First of all, even if the cells are simply frozen, in a medical institution, a doctor should.

This means that if you leave a medical institution, you must obtain permission for the slightest manipulation, as specified in the regulation related to the Law on Pharmaceutical Affairs, and the Ministry of Food and Drug Safety has disclosed this several times.

Looking at the promotional video for Pamicel in the past, it is questionable if the stem cells were frozen, not the blood from the bone marrow.

[파미셀 홍보 영상 : 실제 과정을 살펴보면, 운송된 골수에서 줄기세포를 분리해 보관에 들어가는데요, 여기에는 약 7일이 소요됩니다.]

Considering the fact that it takes about a week to obtain stem cells by culturing mononuclear cells isolated from the blood of the bone marrow, it can be suspected that the stem cells are frozen rather than simply collecting blood from the bone marrow. .

I was able to hear more details from the former Phamicel Stem Cell Lab staff.

When I thawed the bone marrow of a bank customer to make HeartiCellgram, some defects came out where the stem cells were not cultured, and because of this, the stem cells were cultured and then frozen to see if they could be manufactured and sold as a treatment.

[오일환 / 가톨릭대학교 의과대학 세포치료센터 소장 : 단순 냉동 및 해동은 최소 조작의 범위 안에 들어가지만, 해동된 것을 배양할 때는, 일반적인 다른 세포들도 배양할 때는 그것이 세포 치료제로서의 안전성에 대한 검사를 다시 받도록 돼 있습니다.]

In the HeartiCelgram manufacturing process, it seems necessary to investigate whether an unauthorized freezing of stem cells was actually performed.

This is because the safety and efficacy of the world’s first stem cell treatment cannot be guaranteed.

This is YTN Kim Woong-rae.

[저작권자(c) YTN & YTN plus 무단전재 및 재배포 금지]