Ensieh Hajizadeh, a physician, medical biotechnology specialist, and director of the Royan Institute's Advanced Cellular Products Technology Development Center, detailed the production process of embryonic stem cells in a discussion with the Tasnim News Agency.

She announced the institute's success in creating the strategic product "Binacell" for treating eye retinal diseases.

In explaining the center's efforts, Hajizadeh stated, "One of the very valuable works that the Royan Institute has done is the research and studies conducted in the field of embryonic stem cells."

"The nature of embryonic stem cells goes back to the time when all of us were just a few cells at the beginning of formation; that is, when sperm and egg fertilize each other, first an eight-cell ball is formed, and after progress, it turns into a ring."

She added, "This ring-like structure has a number of cells from which all types of cells in our body, that is, all those 220 types of cells that exist in the body, are formed."

"We call these 'pluripotent stem cells' that have the ability to build all the cells of the body."

"The great work that Royan did was that years ago, before many countries entered this field, it started research on these cells and was able to institutionalize this science very quietly within itself and advance it."

Shifting to the institute's focus on practical applications, the director of the Advanced Cellular Products Technology Development Center at Royan Institute emphasized the approach to turning knowledge into use.

She asserted, "The next step was that Royan decided to turn its science into application."

"As a result, it directed all the knowledge it had in the field of embryonic stem cells toward application to determine how it could be used," she noted. 

"In this regard, embryonic stem cell lines were produced as 'lines' in a clean room space, which we call 'GMP Grade cell lines'."

Hajizadeh continued, "When the product's grade is 'GMP,' it means it has permission for human transplantation; because it is produced in a clean space free of any particles and microbial bodies, and from the perspective of the Food and Drug Organization, which has complete supervision over this process, it has permission to enter the clinical process and human transplantation."

The medical biotechnology specialist described the aforementioned achievement as akin to a treasure.

"These cells are firstly cell lines, meaning they are immortal and can divide billions of times and produce a very large number of similar cells," she stated. 

"Secondly, these are embryonic cells, meaning if placed in a suitable environment, they can build all the cells of our body; therefore, they are considered a very valuable treasure."

Outlining the therapeutic uses of these cells, she said, "Suppose we have a disease that affects the nervous system; it is enough to direct this cell toward differentiation to build neural neurons. Or suppose in diseases like macular dystrophy, the eye's retina gradually deteriorates.

"If we differentiate this embryonic stem cell in the laboratory environment toward producing that retinal cell, by transplanting it into the eye in that specific disease, we can restore the lost vision.

"In the same way, insulin-producing cells for diabetes or heart cells can also differentiate from this stem cell."

Introducing the "Binacell" product, Hajizadeh added, "The 'Binacell' product is actually an embryonic stem cell differentiated into 'RPE' cells or retinal pigment epithelial cells.

"This is precisely another product known as part of the products obtained from pluripotent stem cells, and currently its application is for age-related macular degeneration disease."

The director of the Advanced Cellular Products Technology Development Center at Royan stressed, "The principle of having this embryonic stem cell produced in a clean room with clinical usability is knowledge that is exclusively available to Royan, and very few countries in the world have access to it.

"Royan is currently working in the clean room space on various cells differentiated from this embryonic cell to turn them into technology transplantable to humans."

Noting the upcoming stages for the product, she remarked, "As mentioned, the product for eye retinal damage, as well as another product, will both soon start in the clinical phase, but human transplantation has not yet been performed."