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Cell Therapy
Decidual Stromal Cells for Graft-versus-Host Disease
Phase 2
Waitlist Available
Research Sponsored by University Health Network, Toronto
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Confirmed diagnosis of steroid-refractory aGvHD defined as patients administered high dose systemic corticosteroids (methylprednisolone ≥1mg/kg/day [or equivalent prednisone dose ≥1.25 mg/kg/day]), given alone or combined with calcineurin inhibitors (CNI) and either: A. Progression based on organ assessment after at least 3 days compared to organ stage at the time of initiation of high-dose systemic corticosteroid +/- CNI for the treatment of Grade II-IV aGvHD, OR B. Failure to achieve at a minimum partial response based on organ assessment after 5-7 days compared to organ stage at the time of initiation of high-dose systemic corticosteroid +/- CNI for the treatment of Grade II-IV aGvHD, OR C. Patients who fail corticosteroid taper defined as fulfilling either one of the following criteria: Requirement for an increase in the corticosteroid dose to methylprednisolone ≥1 mg/kg/day (or equivalent prednisone dose ≥1.25 mg/kg/day) OR Failure to taper the methylprednisolone dose to <0.5 mg/kg/day (or equivalent prednisone dose <0.6 mg/kg/day) for a minimum 7 days
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years, through study completion
Awards & highlights
Study Summary
This trial is testing whether Decidual Stromal Cells can help treat patients with a severe form of Graft versus Host Disease who have not responded to steroids.
Who is the study for?
This trial is for adults over 18 who've had a stem cell transplant and are now facing severe acute Graft versus Host Disease (GvHD) that hasn't improved with steroids. They should not have HIV, severely impaired kidney function, or be pregnant. Also, they can't join if they've been treated with other drugs for GvHD apart from steroids or have an uncontrolled infection.Check my eligibility
What is being tested?
The study compares the effectiveness of Decidual Stromal Cells (DSC) against the best available treatments like anti-thymocyte globulin and others for severe acute GvHD. Participants will receive DSC infusions in their veins at least one week apart, possibly up to four doses depending on how well they respond.See study design
What are the potential side effects?
Potential side effects may include reactions related to infusion such as fever or chills, risk of infections due to immune system suppression by the treatment, and possible organ inflammation.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My condition did not improve after high-dose steroid treatment for aGvHD.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years, through study completion
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years, through study completion
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
To compare the efficacy of DSC vs. Investigator's choice Best Available Therapy (BAT) in patients with Grade II-IV SR-aGvHD assessed by Durable Overall Response Rate (DOR) at Day 56
Secondary outcome measures
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
To assess 1-year Non-Relapse Mortality (NRM)
To assess 1-year Overall Survival (OS)
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: DSCExperimental Treatment1 Intervention
The dose will be 1×106 DSC/kg bodyweight, at least 2 doses at least one week apart. Within the first 28 days, patients meeting criteria of aGvHD disease progression, mixed response or no response, may be given additional weekly doses of DSC until satisfactory response (ie: CR) are reached (max 4 doses in total).
Group II: BATActive Control1 Intervention
anti-thymocyte globulin (ATG), extracorporeal photopheresis (ECP), mTOR inhibitors (everolimus or sirolimus), vedolizumab, ruxolitinib.
Find a Location
Who is running the clinical trial?
University Health Network, TorontoLead Sponsor
1,468 Previous Clinical Trials
484,440 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- My condition did not improve after high-dose steroid treatment for aGvHD.I have severe lung problems and need help breathing or my oxygen levels are usually below 90%.My kidney function is severely impaired, indicated by high creatinine levels or I require dialysis.I have acute GvHD after a stem cell transplant and need treatment.I do not have an active infection that is getting worse despite treatment.I have symptoms of both acute and chronic graft-versus-host disease.I have had progressive multifocal leukoencephalopathy in the past.I have had a stem cell transplant from any donor using various sources.I have been treated for aGvHD with medications other than steroids.I am not on high-dose steroids for conditions other than graft-versus-host disease.I am HIV positive.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: DSC
- Group 2: BAT
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are people still being accepted into the trial at this time?
"The trial is presently seeking patients, as per the clinicaltrials.gov website. This information is accurate as of 2/3/2022 and was initially posted on 12/22/2021."
Answered by AI
Are Decidual Stromal Cells dangerous to human health?
"Decidual Stromal Cells have not been proven effective yet in any clinical trials, however Phase 2 data supports that it is safe. Therefore, we've given it a safety score of 2."
Answered by AI
Are there limits to how many people can be a part of this research?
"That is correct. The trial, which was originally posted on December 22nd 2021 and updated February 3rd 2022, is still seeking participants. They are looking for 50 people total at 1 location."
Answered by AI
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