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Iranian WhartoCell Medicine for Osteoarthritis Treatment Receives IFDA Authorization

Tehran: WhartoCell, an Iranian knowledge-based medicine developed from umbilical cord-derived stem cells, has entered clinical therapy after receiving authorization from Iran Food and Drug Administration (IFDA), a government regulatory body. The director of public relations at Royan Institute, a non-governmental non-profitable organization in Tehran, provided details to reporters on Sunday about WhartoCell, developed at the institute using indigenous knowhow, marking another step in expanding regenerative medicine technologies in Iran.

According to Islamic Republic News Agency, Mehdi Lotfipanah stated that WhartoCell, the product developed using umbilical cord stem cells, helps reduce inflammation, support cartilage regeneration, and improve joint function in patients suffering from osteoarthritis. He emphasized the need for wider application of these innovative cell-based therapies by physicians and healthcare providers to facilitate biotechnology and regenerative medicine technologies.

Lotfipanah called the approval of WhartoCell by the IFDA for osteoarthritis treatment an achievement that indicates the maturity of new therapeutic technologies in the country. He noted that the drug is a new generation of allogeneic cell therapy extracted from the Wharton gel of the newborn's umbilical cord. High-potent mesenchymal stem cells have the ability to help regenerate damaged tissues, modulate the immune response, and reduce inflammation. One key advantage of WhartoCell is easier access for patients and medical centers due to domestic knowledge and infrastructure.

While explaining the strict GMP (Good Manufacturing Practices) standards, Lotfipanah said the medicine, with its high replication capacity and low immunogenicity, is fully controlled in terms of quality and safety throughout the production process. He also highlighted the competitive advantage of this product, stating that wide compatibility is another feature of WhartoCell, as it can be used without the need for HLA matching between the donor and the recipient, simplifying and expediting the therapy process at medical centers.

Although initially approved for osteoarthritis, researchers suggest the technology may have broader applications in regenerative medicine, including cartilage repair, tendon and ligament injuries, bone fracture healing, avascular necrosis (AVN), and the management of inflammatory joint disorders. Lotfipanah mentioned that the Royan Institute plans to internationalize WhartoCell through workshops, scientific meetings, and activities alongside the upcoming 27th International Royan Congress.