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Cellular Immunotherapy

Umbilical Cord Mesenchymal Stromal Cells (UC-MSCs) for 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)

Awards & highlights

UC-CISSII Trial 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.Check my eligibility

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.See study design

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.

UC-CISSII Trial 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)

This trial's timeline: 3 weeks for screening, Varies for treatment, and during index study hospital admission (through study completion, up to 1 year) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Days free from mechanical ventilation and/or vasopressors and/or renal replacement therapy

Secondary outcome measures

Biomarkers - Acute kidney injury

Biomarkers - Inflammatory mediators and cytokines

Biomarkers - Muscle weakness

+17 more

UC-CISSII Trial 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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Technische Universität DresdenOTHER

283 Previous Clinical Trials

2,271,859 Total Patients Enrolled

Canadian Critical Care Trials GroupOTHER

30 Previous Clinical Trials

227,989 Total Patients Enrolled

4 Trials studying Shock

1,611 Patients Enrolled for Shock

Stem Cell NetworkOTHER

8 Previous Clinical Trials

299 Total Patients Enrolled

1 Trials studying Shock

114 Patients Enrolled for Shock

Frequently Asked Questions

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

What is the current number of individuals being recruited for participation in this research study?

"Indeed, information from clinicaltrials.gov confirms that this investigation is actively seeking suitable candidates. The trial was initially shared on February 14th, 2024 and most recently revised on the same day. The study aims to enroll a total of 296 participants at two distinct sites."

Answered by AI

Are there any available positions for patients in this ongoing clinical trial?

"Affirmative. Information available on clinicaltrials.gov indicates that this investigation is actively seeking participants. Initially shared on February 14, 2024, and most recently revised on the same day, this research aims to enroll a total of 296 patients from two distinct sites."

Answered by AI

What are the potential risks associated with Umbilical Cord Mesenchymal Stromal Cells (UC-MSCs) for individuals receiving treatment?

"Our team at Power assesses the safety of Umbilical Cord Mesenchymal Stromal Cells (UC-MSCs) as a 2 on our scale. This rating reflects that while there is existing data supporting safety, no evidence has been found to support efficacy in this Phase 2 trial."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Umbilical Mesenchymal Stromal Cells as Cellular Immunotherapy for Septic Shock

2024. "Umbilical Mesenchymal Stromal Cells as Cellular Immunotherapy for Septic Shock". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05969275.

All > Pathology > Sepsis