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Cellular Immunotherapy
Stem Cell Therapy for Septic Shock (UC-CISSII Trial)
Phase 2
Recruiting
Led By Lauralyn McIntyre, MD
Research Sponsored by Ottawa Hospital Research Institute
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 during index study hospital admission (through study completion, up to 1 year)
Summary
"This trial looked at using mesenchymal stem cells to treat patients with septic shock. The initial trial showed that the stem cells were safe and now they are planning a larger trial to evaluate how
Who is the study for?
This trial is for adults over 18 in intensive care with septic shock, needing certain levels of drugs to maintain blood pressure, respiratory or kidney support, or showing signs of organ failure due to infection. They must be within the first 48 hours of these conditions being identified upon ICU admission.
What is being tested?
The study tests if mesenchymal stromal cells from umbilical cords can help treat septic shock by modulating inflammation and enhancing recovery. It's a phase II randomized controlled trial comparing these cells' effects against a placebo.
What are the potential side effects?
While specific side effects are not listed here, previous trials suggest that mesenchymal stromal cells may be safe. However, potential risks could include immune reactions or complications related to infusion.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ during index study hospital admission (through study completion, up to 1 year)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~during index study hospital admission (through study completion, up to 1 year)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Days free from mechanical ventilation and/or vasopressors and/or renal replacement therapy
Secondary study objectives
Biomarkers - Acute kidney injury
Biomarkers - Inflammatory mediators and cytokines
Biomarkers - Muscle weakness
+17 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Umbilical Cord Mesenchymal Stromal Cells (UC-MSCs)Experimental Treatment1 Intervention
Intravenous infusion of 300 million allogeneic, cryopreserved, umbilical cord-derived human mesenchymal stromal cells
Group II: PlaceboPlacebo Group1 Intervention
Intravenous infusion of placebo, with excipients
Find a Location
Who is running the clinical trial?
Technische Universität DresdenOTHER
290 Previous Clinical Trials
2,271,746 Total Patients Enrolled
Canadian Critical Care Trials GroupOTHER
31 Previous Clinical Trials
227,529 Total Patients Enrolled
1 Trials studying Systemic Inflammatory Response Syndrome
80 Patients Enrolled for Systemic Inflammatory Response Syndrome
Stem Cell NetworkOTHER
8 Previous Clinical Trials
299 Total Patients Enrolled
1 Trials studying Systemic Inflammatory Response Syndrome
114 Patients Enrolled for Systemic Inflammatory Response Syndrome
Center for Regenerative Therapies Dresden (CRTD)UNKNOWN
Ottawa Hospital Research InstituteLead Sponsor
577 Previous Clinical Trials
3,139,652 Total Patients Enrolled
1 Trials studying Systemic Inflammatory Response Syndrome
114 Patients Enrolled for Systemic Inflammatory Response Syndrome
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,392 Previous Clinical Trials
26,527,170 Total Patients Enrolled
2 Trials studying Systemic Inflammatory Response Syndrome
7,621 Patients Enrolled for Systemic Inflammatory Response Syndrome
Lauralyn McIntyre, MDPrincipal InvestigatorThe Ottawa Hospital Research Institute
2 Previous Clinical Trials
123 Total Patients Enrolled
1 Trials studying Systemic Inflammatory Response Syndrome
114 Patients Enrolled for Systemic Inflammatory Response Syndrome