Iranian WhartoCell medicine for osteoarthritis treatment receives IFDA authorization
Tehran, IRNA – 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, gave details to reporters on Sunday about WhartoCell that was developed at the institute using indigenous knowhow, marking another step in the expansion of regenerative medicine technologies in Iran.
Mehdi Lotfipanah said that WartoCell, the product developed using umbilical cord stem cells, helps reduce inflammation, support cartilage regeneration, and improve joint function in patients suffering from osteoarthritis.
Referring to the introduction of innovative cell-based therapies, he emphasized the need for wider application of those products by physicians and healthcare providers, in order to facilitate biotechnology and regenerative medicine technologies.
He called the approval of WartoCell by the IFDA for osteoarthritis treatment an achievement that also indicates the maturity of new therapeutic technologies in the country, adding that the drug is a new generation of allogeneic cell therapy extracted from the Wharton gel of the newborn's umbilical cord.
According to him, high-potent mesenchymal stem cells have the ability to help regenerate damaged tissues, modulate the immune response, and reduce inflammation. One of the key advantages of WartoCell is easier access for patients and medical centers because of domestic knowledge and infrastructure, he added.
Lotfipanah, while explaining the strict GMP (Good Manufacturing Practices) standards, said the medicine, with its high replication capacity and low immunogenicity, is fully controlled in terms of quality and safety throughout the production process.
The director of public relations at Royan Institute also underscored 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, which makes the therapy process simpler and faster at medical centers.
Although initially approved for osteoarthritis, researchers say 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 has said that the Royan Institute plans to internationalize WhartoCell, through workshops, scientific meetings, including activities alongside the upcoming 27th International Royan Congress.
