The approval marks another step in the expansion of regenerative medicine technologies in the country.
The product, WhartoCell, was developed by researchers at Royan Institute using domestically developed technology.
According to Mehdi Lotfipanah, Director of Public Relations and International Affairs at Royan Institute, the therapy is designed to reduce inflammation, support cartilage regeneration, and improve joint function in patients with osteoarthritis.
"The introduction of innovative cell-based therapies requires a scientific and evidence-based approach to ensure their appropriate integration into clinical practice," Lotfipanah said.
He added that greater awareness among physicians and healthcare providers would facilitate broader adoption of regenerative medicine technologies.
Turning to the product's technical profile, WhartoCell is an allogeneic stem cell therapy derived from Wharton's jelly of the neonatal umbilical cord.
The mesenchymal stem cells used in the product have anti-inflammatory and immunomodulatory properties while supporting tissue repair and regeneration.
One of its distinguishing features is that it does not require genetic matching, or HLA matching, between donor and recipient, allowing physicians to administer the treatment without lengthy preparation procedures.
As an off-the-shelf therapy, it is expected to improve patient access to advanced regenerative treatments.
On manufacturing standards, Royan Institute said the product is made under Good Manufacturing Practice standards, with quality and safety monitored throughout production.
Looking ahead, although WhartoCell was 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, and the management of inflammatory joint disorders.
Lotfipanah said the product also represents an important achievement in developing indigenous biotechnology, reducing dependence on imported therapeutic products while expanding access for healthcare providers across the country.
He noted that Royan Institute plans to increase scientific communication around WhartoCell through specialized workshops, educational programs for physicians and patients, and scientific meetings, including activities tied to the upcoming 27th International Royan Congress.
Royan Institute is one of Iran's leading centers for stem cell research and regenerative medicine, and has developed several advanced cell-based therapeutic technologies over the past two decades as part of the country's growing biotechnology sector.