What side effects are associated with this type of intervention?

Common treatments for septic shock include antibiotics, vasopressors, and supportive therapies such as fluid resuscitation. Antibiotics can cause side effects like allergic reactions, gastrointestinal disturbances, and antibiotic resistance. Vasopressors, used to maintain blood pressure, may lead to arrhythmias, ischemia, and extravasation injuries. Supportive therapies can result in fluid overload and electrolyte imbalances. Treatments similar to Enhanced Mesenchymal Stromal Cells (GEM00220), which aim to modulate inflammation, are still under investigation, but potential side effects may include immune reactions, infection risks, and complications related to cell administration.

What prior FDA approvals exist?

There are no specific FDA-approved treatments that directly match the investigational approach of Enhanced Mesenchymal Stromal Cells (GEM00220) for septic shock, which focuses on modulating host inflammation. Historically, treatments for septic shock have included broad-spectrum antibiotics, intravenous fluids, and vasopressors to maintain blood pressure. While various anti-inflammatory and immunomodulatory agents have been explored in clinical trials, none have demonstrated consistent efficacy to gain FDA approval specifically for septic shock. The investigational use of mesenchymal stromal cells represents a novel approach that is still under clinical evaluation.

What other types of research exist?

Promising novel alternatives to Enhanced Mesenchymal Stromal Cells (GEM00220) for septic shock patients include: 1) Hemoperfusion with polymyxin-B immobilized fiber, which has shown improved oxygenation and survival rates in patients with acute exacerbations of idiopathic pulmonary fibrosis (AE-IPF). 2) Tacrolimus combined with methylprednisolone pulse therapy, which has demonstrated improved survival in AE-IPF patients. These therapies have shown potential in modulating inflammation and improving outcomes in related conditions, making them worth considering for septic shock treatment.

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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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 28 days

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing special cells (GEM00220) that help control inflammation in patients with severe infections (septic shock). The goal is to see if these cells are safe and can help reduce the body's harmful overreaction to infection. Initially, a small group will be tested for safety, and then the study will continue to see if the treatment shows early signs of benefit.

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.

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.

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 28 days

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Maximum Feasible Tolerated Dose

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for septic shock focus on modulating the host's inflammatory response and restoring tissue perfusion. Enhanced Mesenchymal Stromal Cells (GEM00220) aim to modulate inflammation by altering immune function and providing paracrine signals to reduce the excessive inflammatory response seen in septic shock. This is crucial as the hyperinflammatory state can lead to multiple organ failure. Standard treatments include aggressive fluid resuscitation to restore perfusion, typically using crystalloids, and early administration of broad-spectrum antibiotics to target the underlying infection. These interventions are essential to stabilize the patient and prevent further complications.

Preclinical sepsis models.Pathogenetic aspects of sepsis and possible targets for adjunctive therapy.