Study Finds Comparable CAR-T Outcomes Across Accredited and Non-Accredited Centers

New research from Florida Cancer Specialists & Research Institute (FCS) is adding to ongoing discussions about how to balance quality oversight with patient access in the rapidly growing field of cellular therapy. According to findings presented at the 2026 American Society of Clinical Oncology Annual Meeting, patients receiving chimeric antigen receptor T-cell (CAR-T) therapy experienced comparable quality and safety outcomes whether treatment was delivered at accredited or non-accredited centers.¹

The study comes as demand for CAR-T therapies continues to increase across hematologic malignancies. While these personalized cell therapies have transformed treatment options for patients with certain blood cancers, access remains limited due to the specialized infrastructure, staffing, and training required to administer them.² Historically, accreditation programs have served as an important benchmark for ensuring centers meet rigorous standards related to cellular therapy delivery, including quality management systems, staff training, patient monitoring, and adverse event reporting.³

What did the study find?

Investigators analyzed outcomes among patients treated with CAR-T therapies at both accredited and non-accredited facilities. According to the study, quality and safety measures were comparable across treatment settings, with no significant differences observed in key clinical outcomes.¹

The findings challenge the assumption that accreditation status alone is a reliable predictor of patient outcomes. Researchers noted that care teams at non-accredited centers may still possess substantial expertise in administering cellular therapies and managing associated toxicities, even if they have not completed formal accreditation processes.

As CAR-T therapy becomes more widely used, understanding which factors truly influence patient outcomes will become increasingly important for healthcare systems, providers, and policymakers.

Why does treatment location matter?

One of the most significant barriers facing CAR-T patients is geography.

Because many accredited treatment centers are concentrated in major metropolitan areas or large academic medical centers, patients often must travel long distances to receive care. For individuals who are seriously ill, frequent travel can create logistical, financial, and emotional burdens.

In some cases, travel requirements may delay treatment initiation or discourage patients from pursuing therapy altogether. Expanding the number of facilities capable of delivering CAR-T treatment could help address these challenges and potentially improve access for patients living in rural or underserved regions.

The researchers emphasized that treatment location itself may be a critical driver of access. If outcomes remain comparable across different care settings, expanding treatment availability could allow more patients to benefit from potentially life-extending cellular therapies without sacrificing quality.

What role does accreditation play in CAR-T therapy?

Accreditation programs remain an important component of the cellular therapy ecosystem. These programs establish standards related to staff training, quality management systems, patient monitoring, and adverse event reporting.

The FCS researchers stressed that their findings should not be interpreted as diminishing the value of accreditation. Rather, the results suggest that accreditation status alone may not fully capture a center's ability to safely administer CAR-T therapies.

As the cellular therapy field matures, stakeholders may increasingly examine whether current accreditation requirements appropriately reflect real-world outcomes and whether additional pathways could safely expand treatment capacity.

Such discussions are particularly relevant as next-generation cellular therapies continue moving through clinical development and into commercial practice.

What could the findings mean for the future of CAR-T delivery?

The study arrives at a time when healthcare systems are seeking ways to scale cellular therapy infrastructure to meet growing demand for cellular therapies and other advanced cancer treatments.⁴

CAR-T therapies are now approved for multiple hematologic malignancies, and additional indications are expected to emerge soon. Expanding access while maintaining safety and quality standards remains a central challenge for treatment centers and regulators alike.

The findings presented by FCS suggest that evaluating real-world patient outcomes may be an important part of determining how CAR-T therapy is delivered in the future. If similar results are confirmed through additional studies, policymakers and healthcare organizations may consider strategies that allow qualified non-accredited centers to play a larger role in treatment delivery.

References

1. Study finds comparable quality and safety outcomes in CAR-T cell therapy across accredited and non-accredited centers, highlighting care location as key driver of patient access. (2026 May 28). Florida Cancer Specialists & Research Institute. https://www.flcancer.com/articles/fcs-fact-study/
2. Hansen, D. K., Liu, Y. H., Ranjan, S., Bhandari, H., Potluri, R., McFarland, L., De Braganca, K. C., & Huo, S. (2023 Dec 7). The Impact of Outpatient versus Inpatient Administration of CAR-T Therapies on Clinical, Economic, and Humanistic Outcomes in Patients with Hematological Cancer: A Systematic Literature Review. Cancers. https://doi.org/10.3390/cancers15245746
3. Standards and Accreditation Programs. Foundation for the Accreditation of Cellular Therapy (FACT). https://www.factglobal.org. Accessed May 28, 2026.
4. Mora A, Barnes L, Divine C, et al. (2023 Nov). The Cell and Gene Therapy Consortium's Perspective on Harmonizing Data Collection for Patient Enrollment, Therapy Ordering and Scheduling, and Cell Collection Transplantation and Cellular Therapy. Official Publication of the American Society for Transplantation and Cellular Therapy. https://www.astctjournal.org/article/S2666-6367(23)01468-9/fulltext