On January 2, the State Food and Drug Administration conditionally approved the marketing of my country's first stem cell treatment drug, Amimetosa Injection, through the priority review and approval process. This is a rare disease medication used to treat complications after hematopoietic stem cell transplantation due to hematological diseases over the age of 14.

According to reports, graft-versus-host disease is one of the main complications after allogeneic hematopoietic stem cell transplantation and may cause death when the condition is severe. The drug is marketed as a prescription drug and will be used in hospitals to treat corresponding diseases with doctor prescriptions, providing patients with new treatment options.

What diseases are the mesenchymal stem cell drugs approved by my country used to treat? Aimimaitoxin injection is the first mesenchymal stem cell (MSCs) therapeutic drug approved for marketing in my country. It is used for acute graft-versus-host disease (aGVHD) where hormone therapy fails. GVHD is a type of multi-organ syndrome that occurs after allogeneic hematopoietic stem cell transplantation when lymphocytes from the donor attack the recipient's tissues. It can affect the skin, gastrointestinal tract, liver, lungs and mucosal surfaces. GVHD is divided into acute GVHD (aGVHD), chronic GVHD (cGVHD), and overlapping syndromes with both characteristics. It is one of the causes of non-recurrent death after allogeneic hematopoietic stem cell transplantation. Prevention and treatment of GVHD is of great significance for successful allogeneic hematopoietic stem cell transplantation, long-term survival after transplantation and improving patients 'quality of life.

At present, clinical trials of mesenchymal stem cells for the treatment of other diseases are still in progress, and there is no definitive clinical safety and effectiveness data.

Are stem cell drugs omnipotent? What are the misunderstandings in treatment? At present, stem cell drugs in the fields of immune damage, diabetes, liver and other diseases have entered the clinical trial stage. However, experts suggest that stem cells are not a panacea and require strict clinical trials and cannot be blindly used for treatment.

So, can the so-called "stem cell products" appearing on the market be used by individuals? What are the risks of using it in non-medical institutions?

Experts said that the so-called "stem cell products" inject foreign active substances into the body. If they are not compliant, there will be potential risks such as inflammation, foreign body reactions, and even infection. What's more, some products have been sold under the banner of "oral stem cells". Experts remind that there is no clinical evidence to prove that oral stem cells can play a therapeutic role.

The State Food and Drug Administration reminds that after mesenchymal stem cell therapeutic drugs are approved for marketing, as prescription drugs for the treatment of specific diseases, they should be used in regular hospitals under the guidance of doctors on prescription, and in strict accordance with the indications and usage specified in the instructions. Standardize use such as requirements.