Ignite Creation Date:
2025-12-25 @ 12:23 AM
Ignite Modification Date:
2025-12-25 @ 10:28 PM
Study NCT ID:
NCT04961658
Status:
TERMINATED
Last Update Posted:
2024-04-16
First Post:
2021-06-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Advanced Mesenchymal Enhanced Cell THerapY for SepTic Patients
Sponsor:
Northern Therapeutics
Organization:
Study Overview
Official Title:
Advanced Mesenchymal Enhanced Cell THerapY for SepTic Patients
Status:
TERMINATED
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Funding Decision
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
AMETHYST
Brief 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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: