Regional
Therapeutic apheresis and the cell therapy laboratory at King Faisal Specialist Hospital & Research Centre, Saudi Arabia
Abdullah Alswied
King Faisal Specialist Hospital & Research Center, Saudi Arabia
Nour Al-Mozain
King Faisal Specialist Hospital & Research Center, Saudi Arabia
Cellular therapy in Saudi Arabia has a history spanning more than four-decades with its origins at King Faisal Specialist Hospital & Research Centre (KFSHRC) in Riyadh (Figure 1).
Established in 1970, KFSHRC performed Saudi Arabia’s first hematopoietic stem cell transplantation in 1984. This milestone marked the establishment of the first HSCT program in the Kingdom and positioned KFSHRC as a pioneering transplantation center in the Eastern Mediterranean Region and the Middle East.1
From that first transplant, HSCT activity expanded rapidly across the Kingdom. Four leading Saudi centers reported a combined total of 6,184 HSCTs performed between 1984 and 2016, including 3,586 in adults and 2,598 in children.1 The Saudi Society of Blood and Marrow Transplantation later reported a cumulative total of 15,031 transplants performed nationwide since the establishment of the first program, with the transplant rate per 10 million inhabitants approximately doubling with each decade.2 By 2024, KFSHRC performed more than 7,400 bone marrow and umbilical cord blood transplants, ranking the institution among the top 2% of facilities worldwide in terms of annual stem cell transplantation volume.3
Every stage of this history depended on continuous coordination and continuous refrainment between the bone marrow transplant clinical team and the cell therapy laboratory, integrating core biotherapy competencies: donor selection and mobilization, apheresis collection, graft processing and manipulation, cryopreservation, and rigorous maintenance of chain of identity and chain of custody. When engineered cellular therapies emerged, these advances built upon four decades of apheresis and cell therapy laboratory infrastructure, accreditation, and expertise. CAR-T and gene therapies thus represent the latest chapters in a cellular therapy journey that began in 1984.
Setting the Stage for Advanced Cell and Gene Therapies
In 2020, KFSHRC introduced CAR-T therapy, opening a new chapter in cellular therapy program in the country. Yet every engineered cell therapy begins long before infusion, starting with therapeutic apheresis. Before a CAR-T product can be manufactured, the patient is assessed by an apheresis physician; appropriate vascular access is secured, and cells are collected to a defined collection target. The cell therapy laboratory then coordinates the critical steps across the product pathway, from product processing and cryopreservation through shipment, receipt, testing, and final release. At KFSHRC, established infrastructure, standardized operating procedures, and a rigorous quality system support this integrated pathway, linking the patient at collection to the final product released for treatment.4,5
In October 2024, KFSHRC reached a defining milestone by treating its 100th patient with CAR-T therapy for relapsed or refractory lymphoid leukemias and lymphomas. By October 2025, the program had treated more than 200 patients since its launch.4 The program now includes two commercial CAR-T products from Novartis and Kite in routine clinical use, and six active advanced-therapy clinical trials spanning malignant and autoimmune diseases. Momentum continues to build, with KFSHRC approaching 300 CAR-T procedures across commercial therapies, clinical trials, and in-house manufactured therapies. Together, these pathways demonstrate not only the program’s expanding scale, but also the increasing complexity, and the level of coordination and precision required to deliver each therapy safely.
A Program in Rapid Growth
In October 2025 our center treated the first patient in the Kingdom with locally manufactured CAR‑T cells, as part of a national phase I/II clinical trial for refractory acute lymphoblastic leukemia.
The product was manufactured in a closed‑system facility in Riyadh. Our in‑house CD19 CART program uses a second generation lentiviral CAR manufactured on a closed, automated platform with a nine day production cycle, followed by cryopreservation pending quality control (QC) release, and release testing for sterility, vector copy number, replication competent lentivirus, transduction efficiency and cytotoxicity. This program represents the first point of care CAR T manufacturing program in Saudi Arabia.
If successfully scaled, local manufacturing could reduce the estimated treatment cost per patient from SAR 1.3 million (approximately USD 347,000) to SAR 250,000 (approximately USD 66,700), while shortening overall manufacturing time from 28 days to 12–14 days. Supporting this ambition is the Kingdom’s first dedicated gene and cell therapy manufacturing complex. Spanning more than 5,000 square meters, the facility is designed to accommodate around 16 modular clean-room clusters, allowing capacity and processes to evolve, expand and adapt alongside emerging therapeutic technologies. The complex represents a milestone in Saudi Arabia’s biotechnology ambitions, integrating precision medicine and advanced manufacturing capabilities together. Once fully operational, it is expected to manufacture approximately 2,400 treatment doses each year—equivalent to roughly 9% of national demand and contribute to an estimated SAR 8 billion (approximately USD 2.13 billion) reduction in care costs by 2030.5,6
Sickle cell disease remains one of Saudi Arabia’s most consequential inherited disorders, with a particularly high burden in the Eastern and Jazan regions. Gene therapy offers a potentially curative approach by modifying a patient’s own stem cells, shifting care beyond lifelong disease management toward durable cure. The approval of exagamglogene autotemcel (Casgevy) in Saudi Arabia for both sickle cell disease and transfusion-dependent β-thalassemia marks an important transition from supportive care to precision-based curative therapy. Apheresis is central to this pathway, enabling the collection of mobilized autologous CD34+ stem cells and progenitor cells that serve as a starting material for exvivo gene editing and subsequent reinfusion.
Figure 1: King Faisal Specialist Hospital & Research Centre (KFSHRC) in Riyadh
Operational Reality Beyond Published Numbers
Our collection volume is 20–30% above the number of patients ultimately treated. The discrepancy between published treatment numbers and our actual procedural activity is an inherent feature of a mature cellular therapy service. Published reports generally count patients who ultimately receive an infusion, whereas therapeutic apheresis activity encompasses every collection undertaken. Some patients require repeat collection because the initial product does not meet required specifications; some protocols require a back-up collection; and others may experience disease progression or become ineligible after collection but before infusion. Each of these procedures require the same level of clinical oversight, coordination, laboratory support, and resources utilization, even when it does not appear in the final number of patients treated. This sustained activity would not be possible without the dedication and close collaboration of our apheresis physicians, nurses, technologists, cell therapy laboratory staff, and the wider multidisciplinary team, whose expertise underpins every successful treatment pathway.
References
1. Shaheen M, Almohareb F, Aljohani N, Ayas M, Chaudhri N, Abosoudah I, et al. Hematopoietic stem cell transplantation in Saudi Arabia between 1984 and 2016: Experience from four leading tertiary care hematopoietic stem cell transplantation centers. Hematol Oncol Stem Cell Ther. 2021 Sep 1;14(3):169–78. doi:10.1016/j.hemonc.2020.07.008 PubMed PMID: 32888899.
2. Shaheen N, Abosoudah I, Alshahrani M, Alzahrani M, Essa M, Alahmari B, et al. Hematopoietic cell transplantation and cell therapy activity landscape survey in the Kingdom of Saudi Arabia; a report from the Saudi Society of Blood and Marrow Transplantation (SSBMT). Bone Marrow Transplantation 2024 59:6. 2024 Mar 8;59(6):867–73. doi:10.1038/s41409-024-02240-3 PubMed PMID: 38459171.
3. KFSHRC Celebrates 40 Years of Stem Cell Leadership at GHE 2024 [Internet]. [cited 2026 Sep 21]. Available from: https://www.kfshrc.edu.sa/en/news/2024/10/kfshrc-celebrates-40-years-of-stem-cell-leadership-at-ghe-2024
4. Ahmed SO, El Fakih R, Kharfan-Dabaja MA, Syed F, Mufti G, Chabannon C, et al. Setting up a Chimeric Antigen Receptor T Cell Therapy Program: A Framework for Delivery from the Worldwide Network for Blood & Marrow Transplantation. Transplantation and Cellular Therapy. 2025 Aug 1;31(8):533–43. doi:10.1016/j.jtct.2025.05.012 PubMed PMID: 40414351.
5. Warda W, Fakih R El, Alrasheed N, Alkhaldi M, Hamideddin N, Alqudairy H, et al. Large Scale In-House Point-of-Care Manufacturing of Clinical Grade Autologous Anti-CD19 CAR T Cells in Saudi Arabia. medRxiv. 2024 Jun 12;2024.06.11.24308741. doi:10.1101/2024.06.11.24308741
6. KFSHRC Launches the First Facility for Gene and Cell Therapy Manufacturing in the Kingdom [Internet]. [cited 2026 Sep 21]. Available from: https://www.kfshrc.edu.sa/en/news/2025/10/kfshrc-launches-the-first-facility
