drugset / Trial / NCT04961658

Advanced Mesenchymal Enhanced Cell THerapY for SepTic Patients

NCT04961658 ↗

Phase 1 Terminated 11 enrolled Northern Therapeutics
Non-randomizedSequentialOpen-labelTreatment

Summary

Bacterial sepsis occurs in patients with severe infections. The condition is caused by toxic substances (toxins) released from bacteria and the patient's elevated inflammatory response to those toxins. In preclinical studies, human mesenchymal stromal cells (MSCs) have been proven to modulate host inflammation in infections, including sepsis. The purpose of the Phase I, open label, dose escalation safety trial is to determine whether escalating doses of enhanced MSCs (GEM00220) are safe and well tolerated in patients with septic shock.

Timeline

Start
2021-08-11
Primary completion
2023-08-10
Completion
2024-01-08

Outcome

Outcome not reported

Stopped (Business): “Funding Decision”

Drugs

EvaluationDrugModalityDoseRoute
Subject GEM00220 Unknown 15 cells Intravenous
Subject GEM00220 Unknown 60 cells Intravenous
Subject GEM00220 Unknown 150 cells Intravenous