First cell therapy product to join the Iranian drug list
According to the report of Public Relations and International Affairs of council for Development of Stem Cell Science and Technologies, in a conversation with Dr. Zirak Saz, CEO of Cell Tech Pharmed Knowledge-Based Company, he said about this company: I would like to introduce Cell Tech Pharmed Company like this Which is the result of the union of two sacred institutions, one is Barakat Pharmaceutical Group and the other is Royan Research Institute. Cell Tech Pharmed Company was established in February 2013 and in 2016, it succeeded in obtaining the ISO 9001: 2015 standard certificate and the ISO 10015 standard certificate.
He further added: Cell Tech Pharmed company reached the operation stage in September 2017. Renudermcell product of this company was unveiled in February 2017 and also obtained GMP certificate (BIO-96-71). This company was officially opened in May 2017. In December 2017, the mesestrocell product was unveiled and the license of phase 4 of the Recolorcell product was obtained. In May 2009, Cell Tech Pharmed Company succeeded in obtaining GMP certification (BIO-98-113) and the company's infrastructure is still developing because this industry needs development and growth.
Product List of cell-Tech Pharmed Company
The CEO of the company stated that so far, a total of more than 50 products have been included in the company's development portfolio, which are different from pharmaceutical products and single drug products. He went on to introduce the products, including the following.
Recolorcell:
Autologous living cell derived from the epidermal layer of the skin, intradermal injection of the skin, treatment of vitiligo, GMP certified, completion of clinical studies of the product and registered in the Iranian drug catalog, receiving IRC
Recolorcell - Vitiligo Cell Therapy (A New Method for Treating Vitiligo)
Vitiligo is a condition in which the cells responsible for skin pigmentation (melanocytes) are destroyed and no longer produce pigment (melanin), resulting in parts of the skin losing their color and causing colorless spots. Areas of the skin and the amount of surface area affected by vitiligo vary from person to person. Research has shown that having vitiligo limits social relationships and lowers a patient's self-esteem. Common treatments include topical ointments, immunosuppressive drugs, phototherapy, and lasers. The high cost of these methods and the lack of proper response of the patient's body, the long treatment period and also the reversibility of the colorless spots caused scientists to seek a new treatment method. Cell therapy is a method that with the help of modern medicine has been able to create new hopes for the treatment of these patients. During the study, 300 patients who did not respond to other treatments were treated with this drug, which improved by 65%, and after the phase 3 phase of the clinical study, with the approval of the Food and Drug Administration, it was included in the country's drug list. It is the first cellular product to enter the country's drug list.
Renudermcell:
Autologous living fibroblast cells derived from the dermal layer of the skin, intradermal injection, treatment and correction of lines around the lips, treatment and correction of indentations of the forehead, around the eyes and between the eyebrows, GMP certified, clinical research study is performed, underway Registration in the Iranian drug list and obtaining IRC
Mesestrocell:
Autologous stem cell derived from the patient's bone marrow, intra-articular injection, treatment of osteoarthritis of the knee, ankle and pelvis, GMP certified, clinical research study is performed, underway Registration in the Iranian drug list and obtaining IRC
Whartocell:
Wharton’ Gelly Mesenchymal Stem Cell Biobank, this cell product is allogeneic and has a very high potential for use in the treatment of incurable diseases such as cerebral palsy (CP), spinal muscular atrophy (SMA), graft versus host disease (GVHD), amyotrophic lateral sclerosis (ALS), MS, primary sclerosing cholangitis (PSC), acute respiratory distress syndrome (ARDS) and as an alternative treatment for diseases such as osteoarthritis, acute myocardial infarction (Acute M.I.), fatty liver grade 2 and 3 is used, the effect of this stem cell in the treatment of diseases mentioned in international and national articles has been proven, Cell Tech Pharmed Company after creating a cell bank of this stem cell, for The existing cell bank has obtained GMP certification and is conducting several clinical studies in the field of using this cellular product in the mentioned diseases. Different forms of medicine have been produced in different volumes and doses of this product and this company is registering different forms and doses of Whartocell are in the list of Iranian medicines and obtaining IRC.
Dr. Zirak Saz continued his speech: "Our country is one of the pioneers in the cell therapy industry. Our position in the world in relation to this science is a leading position. Resources must be managed optimally, especially foreign exchange resources. Therefore, we must consider the interests of the country, and the philosophy of the existence of Cell Tech Pharmed Company makes sense here, where it can develop knowledge and produce the product in a centralized way, and support the medical team in treating patients.
He concluded by citing the words of the Supreme Leader that the achievements of cellular knowledge should be made tangible to the people, which fortunately has happened with the inclusion of Recolorcell in the country's drug list. The product should be provided to special patients at a reasonable price under the support of insurance organizations.
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