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Mesenchymal Stromal Cell Therapy

GEM00220 for Septic Shock (AMETHYST Trial)

Phase 1
Waitlist Available
Research Sponsored by Northern Therapeutics
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
At least 1 other new organ dysfunction defined by the following:
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline to 28 days
Awards & highlights

AMETHYST Trial Summary

This trial will test whether a certain type of cell can help treat septic shock, a dangerous complication from infection.

Who is the study for?
Adults over 18 with septic shock, who have new organ dysfunction and are on vasopressors despite fluid resuscitation. They must be receiving appropriate antibiotics for bacterial sepsis. Exclusions include pregnant women, severe heart or liver disease patients, those with certain cancers or chronic diseases, recent thrombosis, uncontrolled HIV/AIDS, active tuberculosis, and concurrent participation in other drug trials.Check my eligibility
What is being tested?
The trial is testing the safety of different doses of a cell therapy called GEM00220 in adults with septic shock. This Phase I trial involves giving participants escalating doses to see how well they tolerate it and to observe any potential benefits in modulating inflammation caused by infections.See study design
What are the potential side effects?
As this is a Phase I safety trial for GEM00220 (enhanced MSCs), specific side effects are not yet known but may relate to immune system reactions such as fever or allergic responses; organ function changes due to modulation of inflammation; or infusion-related reactions.

AMETHYST Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have dysfunction in one or more organs in your body.

AMETHYST Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline to 28 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 28 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Maximum Feasible Tolerated Dose
The safety of GEM00220 will be assessed by monitoring adverse events

AMETHYST Trial Design

4Treatment groups
Experimental Treatment
Group I: Treatment arm - Dose Cohort 4Experimental Treatment1 Intervention
Participants will receive two doses of GEM00220 at 150 million cells each, seperated by 24 hours
Group II: Treatment arm - Dose Cohort 3Experimental Treatment1 Intervention
Participants will receive a single dose of GEM00220 at 150 million cells
Group III: Treatment arm - Dose Cohort 2Experimental Treatment1 Intervention
Participants will receive a single dose of GEM00220 at 60 million cells
Group IV: Treatment Arm - Dose Cohort 1Experimental Treatment1 Intervention
Participants will receive a single dose of GEM00220 at 15 million cells

Find a Location

Who is running the clinical trial?

Northern TherapeuticsLead Sponsor
2 Previous Clinical Trials
19 Total Patients Enrolled

Media Library

GEM00220 (Mesenchymal Stromal Cell Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04961658 — Phase 1
Septic Shock Research Study Groups: Treatment arm - Dose Cohort 4, Treatment arm - Dose Cohort 3, Treatment Arm - Dose Cohort 1, Treatment arm - Dose Cohort 2
Septic Shock Clinical Trial 2023: GEM00220 Highlights & Side Effects. Trial Name: NCT04961658 — Phase 1
GEM00220 (Mesenchymal Stromal Cell Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04961658 — Phase 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there vacancies still open for potential participants in this trial?

"This medical trial is still open for participants. It was initially posted on the 8th of November 2021 and was revised most recently on November 16th 2022, per clinicaltrials.gov."

Answered by AI

How many individuals are eligible to participate in this research experiment?

"Affirmative. Clinicaltrials.gov reflects that this clinical trial is still searching for 21 volunteers across three sites, with the initial posting dating back to August 11th 2021 and the last modification occuring on November 16 2022."

Answered by AI

Can GEM00220 be used without any substantial risks to users?

"As a Phase 1 trial, the safety of GEM00220 has been determined to be at level 1 as there is limited evidence confirming both its efficacy and safety."

Answered by AI
~3 spots leftby Mar 2025