Umbilical Cord Cell–Based Therapy for Osteoarthritis / Iranian Product “WhartoCell” Introduced into Clinical Practice
The Director of Public Relations and International Affairs at Royan Institute announced that the knowledge-based product WhartoCell, developed on the basis of umbilical cord–derived stem cells and indigenous technology, has received authorization from the Food and Drug Administration for the treatment of osteoarthritis, with the aim of reducing inflammation and promoting cartilage regeneration.
Mehdi Lotfipanah emphasized the necessity of introducing the product through a scientific and specialized framework, stating: “This product, developed using advanced biotechnological and regenerative medicine technologies, is intended to support the improvement of joint function and enhance patients’ quality of life. Accordingly, it requires broader scientific and clinical introduction within the country’s healthcare and research communities.”
Development of WhartoCell Based on Indigenous Technology
He further noted that one of the principal advantages of WhartoCell lies in its development through domestic scientific expertise and infrastructure. This achievement, in addition to reducing dependence on imported alternatives, facilitates broader accessibility for patients and healthcare centers.
Referring to the official regulatory approvals granted to the product, Lotfipanah stated: “As a symbol of a new generation of safe, effective, and high-technology therapeutic approaches, WhartoCell has successfully obtained authorization from the Food and Drug Administration for the treatment of osteoarthritis. This accomplishment reflects the growing maturity of advanced therapeutic technologies within the country.”
He continued: “WhartoCell represents a next-generation allogeneic cell therapy derived from Wharton’s jelly of the neonatal umbilical cord. These highly potent mesenchymal stem cells possess the capacity to support the regeneration of damaged tissues, modulate immune responses, and reduce inflammation.”
Manufacturing Under Stringent GMP Standards
The Director of Public Relations and International Affairs at Royan Institute further emphasized that, owing to its high proliferative potential and low immunogenicity, this product constitutes an innovative therapeutic strategy for the management of degenerative and inflammatory disorders. He added that WhartoCell is manufactured under stringent GMP (Good Manufacturing Practice) standards, and its quality and safety are comprehensively monitored and controlled.
Regarding the therapeutic applications of the product, he explained that the clinical utility of WhartoCell is not limited to osteoarthritis treatment alone, but extends across multiple fields of regenerative medicine. These include alleviation of knee osteoarthritis symptoms, support for cartilage repair and regeneration, enhancement of tendon and ligament healing, facilitation of bone fracture repair, management of avascular necrosis (AVN), and control of joint inflammation.
Usability Without the Need for Genetic Matching
Highlighting the competitive advantages of the product, Lotfipanah stated: “One of the most important characteristics of WhartoCell is its high safety profile and broad compatibility. Due to the immunomodulatory properties of the cells employed, this product can be administered without the need for HLA matching between donor and recipient, thereby simplifying and accelerating the treatment process for medical centers.”
He further added that WhartoCell, as an off-the-shelf allogeneic therapeutic product, is currently available to healthcare institutions as well as the Preventive Medicine and Health Promotion Center of Royan Institute. The elimination of lengthy preparation procedures can play a significant role in facilitating patient access to advanced therapeutic modalities.
The Need for Evidence-Based Scientific Awareness
Emphasizing the importance of building scientific confidence regarding the product, the Director of Public Relations and International Affairs at Royan Institute stated: “In the field of innovative biomedical products, evidence-based awareness is of paramount importance. Accurate presentation of the advantages, applications, and clinical position of WhartoCell, alongside continuous interaction with physicians and healthcare institutions, can pave the way for more effective patient utilization of this achievement.”
According to him, promoting a culture of acceptance of cell-based therapies among physicians and specialists, as well as increasing the adoption of advanced medical technologies for therapeutic purposes, remains among the current challenges in this field. Nevertheless, considering the growing trajectory of scientific research and future projections, broader development and implementation of these technologies are expected in the years ahead.
In conclusion, he announced plans to expand specialized scientific communication regarding the product and stated: “The organization of scientific meetings, specialized workshops alongside medical congresses' including the 27th International Royan Congress; development of educational content for physicians and patients, and active engagement with specialized media outlets are among the planned initiatives aimed at increasing awareness of WhartoCell’s capabilities and facilitating informed clinical utilization of this product.”
