細胞移植治療について

About stem cell (cell transplant) treatment

In a trial filed by FC against us, the court said, "There is no stem cell transplant treatment in the world yet," said a low-level professor of cell transplant technology in Japan. We do not have cell transplantation therapy. I decided. It's too low-dimensional, and I'm really embarrassed as a Japanese person, but was it the person at RIKEN who said this? I remember.

Now then, the following world-famous TED, the TOP of the Megawa Institute at the University of Pittsburgh at the time, and the speech by Alan Russell, who started a cell therapy company with his husband. Who is the cardiac surgeon named Fedirico mentioned in the 14th minute of this speech?

Yes, Fedirico has set up a cell transplant therapy company in collaboration with her husband

World's First Successful Stem Cell Therapy for Heart, Diabetes and Parkinson's Disease

He was a doctor, and under this Alan, he was the first stem cell in the United States.

The FDA-approved doctor for transplantation is called Amit, as well.

He was a doctor who founded a company with his husband.

This was in 2005.

So this judge said

"We don't have cell transplant therapy. The content that said

It's a big mistake, or a bright red lie. It ’s a so-called forged trial.

It means that I met him at the Kangaroo trial.

Do you trust the performers of this world-famous TED?

It's up to you to believe in the unnamed, ignorant judge of stem cells, but ...?

Too much, this judge's decision is embarrassing, somehow,

It is a content that forgets the evolution that makes you want to make a new name called Galapagos Trial.

Or when Columbus discovered the Americas, the Indians

It's like talking about a big ship in front of you, but you couldn't see it at all.

It was a bizarre and bizarre analog trial decision.

Also, this was sent by SG, the new representative of Stem Cell Science, to KN, the old representative.

A description of our cell transplant therapy.

From: SG

Sent: Tuesday, January 29, 2008 8:38 PM
To: KN
Cc: james; MIKI-JIG
Subject:

Mr. N

I haven't heard from you.

I would like to email you because there seems to be a big misunderstanding about my remarks on my future business plan at the last extraordinary general meeting of shareholders. I would like to reiterate exactly what I said.

Regarding the safety of bone marrow cell transplantation, the procedure has been given to a huge number of patients for many years as a treatment for blood diseases, and cattail treatment is also performed in many areas including the cardiovascular area. The combination forms the basis of the treatment methodology we are about to introduce. As a regenerative treatment using bone marrow cells for patients, we already have more than hundreds of achievements in facilities supported by JIG, so we believe that there is no problem with safety. Next, regarding efficacy, the insulin withdrawal rate and insulin weight loss effect for type 2 diabetes are not fully prepared in the standard form of Randamized, Blind controlled, and Multi-center Clinical Trial. This is what I said the effect was not completely established. Mr. Nakajima, an expert, knew that the standard for approved drugs is that post-approval investigations and clinical studies are conducted, but it was misunderstood. Is disappointing. In addition, even in the process approved by the Ministry of Health, Labor and Welfare for new treatment of medical devices other than drugs or in the guidelines prepared by the academic society, the results of Randamized, Blind controlled Clinical Trial at the Single (or a few) center are Class II. It is generally incorporated into Evidence Based Medicine (EBM) as recommended data. JIG's treatment strategy does not reach Class I EBM, but it has a sufficient track record of Class II and has reached a level that can be introduced into clinical practice as free medical care. I think. If not, I'm not involved in this way either. I thought that this point was understood at the time of the contract, but I hope that you will fully understand it again.

Another reason I was trying to introduce cell therapy in free practice could be explained. The current regulation of stem cell therapy creates a situation where clinical trials can only be performed at university hospitals and national centers. With this, the exit is only advanced medical care and insurance medical care. In addition, we must be prepared for at least 5 years to approve stem cell therapy for clinical use, and even if we look at advanced medical treatment for arteriosclerosis obliterans, we expect a sufficient reimbursement price. It is difficult to do so, and it is extremely unlikely that the cost of treatment development will be recovered. As for the exit strategy of the current treatment development type bio-venture, when considering the medical administration situation of the country, I think that there is no other way but to select free medical care as a new exit. Of course, newly developed treatment is an academy's job, but if you have a track record of Class II overseas, it is a waste of time and a disadvantage for the patient to dare to go through the process of academia's clinical trial. I think there is. Fortunately, the Japanese Medical Practitioners Act is very powerful and effective enough to enable the above treatment strategies. It's a parable to explain this, saying that it's the doctor's responsibility to do anything if he doesn't do harmful treatments.

The explanation is insufficient and it seems to be misleading, so I hope that you will fully understand this.

Lastly, regarding the treatment results at hospitals supported by JIG, although there is nothing clearly stated as JIG support in the treatise, it has been fully announced at academic societies. I thought it would be easy to find an expert, let alone a leader doing business in this field. I think that it is possible for a third party to understand that we could not provide information because of insufficient communication and lack of a reliable foundation. In the future, if we can build a sufficient relationship of trust and take over without hesitation, we believe that JIG's technology will be disclosed.