Advanced Mesenchymal Enhanced Cell THerapY for SepTic Patients
Stopped: Funding Decision
Canada11 participantsStarted 2021-08-11
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Adult patients age 18 years and older
. Receipt of appropriate antibiotics for the suspected/confirmed bacterial sepsis as the main diagnosis according to the opinion of the treating staff physician.
. Hypotension documented within 48 hours prior to enrolment that requires the institution and ongoing use of vasopressor agents (phenylephrine, norepinephrine, vasopressin, epinephrine, or dopamine \>5 mcg/kg/min) for at least 3 hours within 24 hours prior to infusion, despite adequate fluid resuscitation in the opinion of the qualified investigator.
. At least 1 other new organ dysfunction defined by the following:
. Renal: Acute kidney injury with creatinine ≥ 150 µmol/L, or ≥ 1.5x the upper limit of normal or the known baseline creatinine, or \< 0.5 ml/kg/hr urine output for 6 hours despite adequate fluid resuscitation or requirement for new renal replacement therapy (patients on chronic hemodialysis or peritoneal dialysis must meet one of the other organ dysfunction criteria)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The safety of GEM00220 will be assessed by monitoring adverse events
. Respiratory: Need for invasive mechanical ventilation or a P/F ratio \< 250
. Hematological: Platelets \< 100 x10\^9/L, or a drop of 50 x10\^9/L in the 3 days prior to enrollment
. Metabolic Acidosis: Arterial pH \< 7.30 in association with base deficit \> 5 mmol/L OR a lactate \>/= to 3.0 mmol/L
Exclusion criteria
. Pregnant or lactating
. Currently receiving extracorporeal life support
. Major surgery within this hospitalization and not prophylactically anticoagulated
. Documented history of a hypercoagulable state (eg Factor V Leiden) or heparin-induced thrombocytopenia (HIT)
. Body Mass Index (BMI) \> 35
. Documented COVID-19 (SARS-CoV2) within 30 days
. Documentation of viral lung infection as the primary diagnosis (e.g. influenza infection, respiratory syncytial virus (RSV) infection, or other laboratory-confirmed viral lung infection)
. Presence of any active malignancy (other than non-melanoma skin cancer) that required treatment within the past year