Decidual Stromal Cells for Graft-versus-Host Disease

Recruiting in Palo Alto (17 mi)

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: University Health Network, Toronto

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

This trial is testing a new treatment using special cells from the uterus lining to help patients with severe GvHD who don't get better with steroids. The goal is to see if these cells can reduce inflammation and improve their condition.

Eligibility Criteria

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.

Inclusion Criteria

My condition did not improve after high-dose steroid treatment for aGvHD.

I have acute GvHD after a stem cell transplant and need treatment.

I have had a stem cell transplant from any donor using various sources.

See 2 more

Exclusion Criteria

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 do not have an active infection that is getting worse despite treatment.

See 9 more

Treatment Details

Interventions

Decidual Stromal Cells (Cell Therapy)

Trial OverviewThe 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.

Participant Groups

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.