Cynata Therapeutics Limited announced that the independent Data Safety Monitoring Board has recommended that Cynata's clinical trial of its lead CymerusTM mesenchymal stem cell (MSC) product CYP-001 should progress to the next stage as planned. Key highlights: All eight participants in Cohort A (lower dose cohort) have demonstrated at least a Partial Response (defined as an improvement in the severity of GvHD by at least one grade compared to baseline) - No treatment-related serious adverse events or safety concerns have been identified - DSMB recommendation to progress clinical trial to second cohort (Cohort B) - Patient enrolment in Cohort B (higher dose cohort) now open at seven trial sites in the U.K. and Australia. Cynata's clinical trial, which is the first clinical trial in which patients have been treated with an allogeneic, induced pluripotent stem cell (iPSC)-derived therapeutic MSC product, consists of a planned total of 16 patients with steroid-resistant acute graft-versus-host disease (GvHD). The recommendation to progress to the next stage (Cohort B) followed an independent review by the DSMB of the eight participants in Cohort A. Recruitment for Cohort A commenced in May 2017, and there are currently seven trial sites active and ready to enrol participants into Cohort B. At this time, seven of the eight participants in Cohort A are alive. One participant died after developing pneumonia, which is a common finding in recipients of bone marrow transplants and similar procedures. This death was not considered to be treatment-related. Participants enrolled in Cohort A of the dose-escalation trial received a dose of CYP-001 that was anticipated to be at the lower end of the effective dose range (one million cells per kilogram of bodyweight, up to a maximum of 100 million cells per infusion). In Cohort B, a further eight participants will receive two infusions of CYP-001 at a dose of two million cells per kilogram of bodyweight, up to a maximum of 200 million cells per infusion.