NCT04961658

Advanced Mesenchymal Enhanced Cell THerapY for SepTic Patients

• Status: Terminated
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Northern Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Septic Shock

Interventions

Type	Name	Description
BIOLOGICAL	GEM00220	Cryopreserved allogeneic, enhanced MSCs administered as a single intravenous infusion

Timeline

• Start date: 2021-08-11
• Primary completion: 2023-08-10
• Completion: 2024-01-08
• First posted: 2021-07-14
• Last updated: 2024-04-16

Locations

4 sites across 1 country: Canada