UMass Chan Medical School, Caring Cross and Trenchant BioSystems have formed a research alliance to develop an automated, lower-cost manufacturing platform for gene-edited stem cell therapies targeting sickle cell disease.

The collaboration brings together academic expertise in blood stem cells, nonprofit access-focused development and automated cell therapy manufacturing technology, with the aim of advancing autologous hematopoietic stem cell (HSC) gene therapies for sickle cell disease and beta-thalassemia.

The partners will work on developing a gene-modified stem cell manufacturing process using Trenchant BioSystems’ AutoCell platform, which is designed for automated cell processing in a place-of-care setting and in ISO class 7 environments. The system uses a microbubble separation approach as an alternative to immunomagnetic bead-based cell separation, with the aim of reducing complexity and facility requirements in manufacturing workflows.

In early-stage work, UMass Chan researchers will evaluate blood-derived material to optimise stem cell separation and support development of gene transfer workflows using lentiviral vectors provided through Caring Cross. The next phase will focus on system validation and process evaluation, including assessment of manufacturing simplicity and cost structure.

Following this, Caring Cross will assess whether the platform could be adopted more broadly as part of its global access-focused manufacturing approach. The organisations also plan to conduct IND-enabling preclinical studies to support a Phase 1/2 clinical trial in sickle cell disease or beta-thalassemia.

A meeting with the US Food and Drug Administration is planned for Q1 2027, with a clinical trial expected to begin in the second half of 2027.

Jennifer E. Adair, vice chair and professor of genetic and cellular medicine and director of the Horae Gene Therapy Center at UMass Chan Medical School, said: “Disruptive technologies such as the AutoCell platform that empower us to tap into the immense unexplored runway between current state of the art ex vivo and in vivo blood cell gene therapies stand to significantly expand and improve access to these transformative medicines.”

Dr Boro Dropulic, executive director of Caring Cross, said: “Caring Cross is dedicated to ensuring the global affordability of advanced therapies, and a key driver for this is the adoption of cell processing platforms that effectively lower barriers to patient care. The Trenchant AutoCell platform has the potential to lower cost, increase scalability, and expand the accessibility of place-of-care manufacturing.”

Jon Ellis, chief executive officer of Trenchant BioSystems, said: “Current cell and gene therapy manufacturing practices are too time consuming and costly to actually deliver CGT therapies to large-scale patient populations. Trenchant BioSystems has now released internal and independent data that confirms that its AutoCell platform is integral to the solution to these challenges, thus scalable globally.”

The alliance positions the partners within a growing push in cell and gene therapy to reduce manufacturing complexity and cost, particularly for autologous therapies that currently require highly specialised infrastructure.

By shifting emphasis toward automated, smaller-footprint production systems and decentralised manufacturing models, the collaboration reflects broader industry efforts to expand access to gene-edited therapies beyond major specialist centres.

The organisations expect the platform to move through preclinical development over the next phase, with regulatory engagement and early-stage clinical testing targeted for 2027.