A Randomized Phase II Study to Compare the Potential Long-Lasting Positive Effect of Decidual Stromal Cells to the Best Available Treatment in Graft Versus Host Disease

Exclusion Criteria

• •1. Has received systemic treatment for aGvHD apart from steroids. Standard aGvHD prophylaxis and treatment medications initiated before randomization including systemic corticosteroids, calcineurin inhibitors (CNI) (cyclosporine or tacrolimus), mycophenolate mofetil, and topical corticosteroid therapy may be continued, per institutional guidelines.
• •2. Clinical presentation resembling de novo chronic GvHD or GvHD overlap syndrome with both acute and chronic GvHD features (as defined by Jagasia, et al. 2015)
• •3. Presence of an active uncontrolled infection including significant bacterial, fungal, viral or parasitic infection requiring treatment. Infections are considered controlled if appropriate therapy has been instituted and, at the time of screening, no signs of progression are present. Progression of infection is defined as hemodynamic instability attributable to sepsis, new symptoms, worsening physical signs or radiographic findings attributable to infection. Persisting fever without other signs or symptoms will not be interpreted as progressing infection. Expections may be allowed upon approval by the Sponsor.
• •4. Known human immunodeficiency virus infection (HIV).
• •5. Significant respiratory disease including patients who are on mechanical ventilation or who have resting O2 saturation \<90% by pulse-oximetry.
• •6. Presence of severely impaired renal function defined by serum creatinine \> 2 mg/dL (\>176.8 μmol/L), renal dialysis requirement, or have estimatedcreatinine clearance \<30 ml/min measured or calculated by Cockroft Gault equation (confirmed within 48h prior to study treatment start).
• •7. Any corticosteroid therapy for indications other than aGvHD at doses \> 1 mg/kg/day methylprednisolone (or equivalent prednisone dose 1.25 mg/kg/day) within 7 days of Screening. Routine corticosteroids administered during conditioning or cell infusion is allowed.
• •8. History of progressive multifocal leuko-encephalopathy (PML).
• •9. Previous participation in a study of any investigational treatment agent within 30 days or within 5 half-lives of the study treatment, whichever is greater.
• •10. Any condition that would, in the Investigator's judgment, interfere with full participation in the study, including administration of study treatment and attending required study visits; pose a significant risk to the patient; or interfere with interpretation of study data.
• •11. Known allergies, hypersensitivity, or intolerance to systemic immunosuppressive therapy.
• •12. Pregnant or nursing (lactating) women