From Regulatory Eligibility to Realized Utilization: Determinants of Uptake for Licensed Cellular Therapies

Marketing authorization defines what may be lawfully manufactured and administered; it does not determine how many indicated patients are treated. In Iran this distinction is structurally visible across three cell-based therapeutic classes that are frequently conflated in policy discussion. Hematopoietic stem-cell transplantation has been performed since ۱۹۹۱ and exceeded one thousand procedures in a single reporting year across nineteen facilities, yet national density remains several-fold below high-income Asia-Pacific comparators and activity is concentrated in a small number of Tehran-based units. In parallel, the Iran Food and Drug Administration has authorized a limited set of current-good-manufacturing-practice somatic products—autologous bone-marrow mesenchymal stromal cells for knee osteoarthritis (MesestroCell), autologous melanocyte-keratinocyte suspensions for vitiligo (RecolorCell), and autologous dermal fibroblasts for selected cutaneous defects (RenuDermCell)—while genetically modified T-cell therapies hold no marketing authorization and therefore no licensed utilization. This article examines the conversion from regulatory eligibility to realized administration through a structured documentary and literature review of ministerial site rules, product licences, multi-centre transplant activity returns, single-centre series, and Iranian clinical studies of licensed or immediately pre-licensed somatic products. Three findings emerge: authorization and administration are dissociable, since legal availability has not translated into population-scale treated cohorts in any class; the binding constraints differ by class, with institutional density, donor acquisition, and late referral dominating transplantation, payer design, geographic concentration, and input supply dominating somatic products, and the absence of a product-indication pair governing engineered T cells; and current Iranian information systems track regulatory events more faithfully than they track the eligible-to-administered cascade, leaving utilization under-measured. The article does not estimate treated fractions of eligible populations, because the requisite denominators and administered-dose registries are not publicly available. It argues instead that class-specific measurement of the eligible-to-treated pathway, stratified by province and payer, is the appropriate dependent variable for Iranian cell-therapy policy; without such measurement, statements about the availability of licensed cellular therapies describe the statute book rather than the clinic

کلیدواژه ها:

Iran ، hematopoietic stem cell transplantation ، mesenchymal stromal cells ، IR-FDA ، health policy.