KFSHRC Commands Nearly Half of Saudi Clinical Trials

King Faisal Specialist Hospital & Research Centre conducted nearly half of all clinical trials registered across the Kingdom during the first half of 2025. With 104 active trials and 80 new studies initiated, it accounted for 48 per cent of the national total, cementing its leading role in Saudi clinical research. KFSHRC held nearly half of all Saudi trials in H1—a figure that underscores its dominance in advancing medical innovation.

Patients at KFSHRC gained access to a broad spectrum of experimental treatments, covering areas such as cancer, cardiovascular, musculoskeletal, dermatological and autoimmune conditions, gastrointestinal and liver disorders, alongside endocrine and metabolic diseases. A landmark achievement this period was the successful treatment of the first patient using locally manufactured CAR-T cells in a Phase I trial for relapsed acute lymphoblastic leukaemia, marking a pivotal advance in the Kingdom’s gene and cell therapy capacities.

This performance builds on KFSHRC’s earlier leadership, notably ending 2024 contributing to 52 per cent of all active clinical studies in Saudi Arabia—a position upheld since that time. The institution’s Clinical Trials Transformation Initiative, launched in 2021, has been pivotal in nurturing research infrastructure, aligning internal departments, and facilitating broader collaboration with national and international partners in areas like regenerative medicine, CRISPR, cancer immunotherapy, and genomic technologies.

KFSHRC is simultaneously broadening its innovation footprint beyond trial activity. The hospital is developing Saudi Arabia’s first modular Advanced Therapy Medicinal Product manufacturing campus in partnership with Germfree Laboratories. Announced at BIO 2025, this modular, CGMP-compliant facility will be constructed on its Riyadh campus, delivering 16 production suites in a scalable, agile format. The approach is projected to shorten timelines by almost half compared with conventional construction while adhering to SFDA, FDA and EMA standards, and enabling clinical and commercial-scale production of cell and gene therapies.

International collaboration remains central to KFSHRC’s expansion. In May 2025, the hospital signed a strategic memorandum of understanding with Cellenkos Inc., a Texas-based biotech firm, launching clinical trial partnerships for T-regulatory cell therapies targeting graft-versus-host disease and aplastic anaemia. This agreement also paves the way for joint efforts in rare disease treatments and the development of local cell and gene therapy manufacturing and training infrastructure.

Institutional recognition further underscores KFSHRC’s stature: it is ranked first in the Middle East and North Africa and 15th globally among the world’s top 250 academic medical centres, as per Brand Finance’s 2025 rankings. It also retains its spot on Newsweek’s list of the World’s Best Smart Hospitals for 2025.