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Advanced Mesenchymal Enhanced Cell THerapY for SepTic Patients — AMETHYST  

Septic Shock Clinical Trial

Official title:
Advanced Mesenchymal Enhanced Cell THerapY for SepTic Patients

Clinical Trial 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.

Clinical Trial Description

This trial consists of 2 sequential parts using the same trial infrastructure: Phase 1a: A dose escalating and safety trial with pre-defined stopping rules for safety. Up to 12 participants will receive a single infusion of GEM00220. If no safety issues are identified, we will continue to the Phase 1b trial at the maximum feasible tolerated dose. Phase 1b: A single-arm, open-label extension of the Phase 1a trial to assess early signs of efficacy (major morbidity and mortality). The Phase 1b trial will enroll up to 9 participants to assess early signals of benefit on mortality and major morbidity in a high risk, high mortality population. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04961658
Study type Interventional
Source Northern Therapeutics
Contact
Status Terminated
Phase Phase 1
Start date August 11, 2021
Completion date January 8, 2024
View Details
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