A Phase 1 interventional study of GEM00220 in Septic Shock, sponsored by Northern Therapeutics. Terminated at 4 sites in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-04-16.
Sponsored by Northern Therapeutics · Phase 1, Interventional, and Treatment
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.
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.
862 studies on the registry are indexed under Shock, Septic; 207 are open to participants now.
This study's enrollment of 11 is below the median of 80 across 530 interventional studies indexed under Shock, Septic.
Browse Shock, Septic studies →Northern Therapeutics is the lead sponsor of 3 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
At least 1 other new organ dysfunction defined by the following:
Exclusion Criteria:
Participants will receive a single dose of GEM00220 at 15 million cells
Biological: GEM00220
Participants will receive a single dose of GEM00220 at 60 million cells
Biological: GEM00220
Participants will receive a single dose of GEM00220 at 150 million cells
Biological: GEM00220
Participants will receive two doses of GEM00220 at 150 million cells each, seperated by 24 hours
Biological: GEM00220
Cryopreserved allogeneic, enhanced MSCs administered as a single intravenous infusion
The safety of GEM00220 will be assessed by monitoring adverse events
Time frame: Baseline to 28 days
Maximum Feasible Tolerated Dose
The highest dose which does not meet any of the pre-defined stopping criteria
Time frame: Baseline to 28 days
Plan to share: No
No publications or documents are linked to this record.
This study is terminated, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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Northern Therapeutics