Cytopeutics® Umbilical Cord Mesenchymal Stromal Cells (Cyto-MSC) for Patients with Grade II–IV Acute Graft-Versus-Host Disease: A Phase I/II Clinical Study – Protocol Overview

Conclusion Study DesignThis is a phase I/II clinical study involving patients who underwent an allogeneic HSCT for malignant or non malignant haematological disorders and developed grade II-IV acute GVHD. A total of 40 eligible patients will be recruited in this study.For Phase I open labelled study, 5 eligible patients will be recruited to receive Cyto-MSC (5 × 106 MSC per kg bodyweight) and standard treatment. Meanwhile, for Phase II double blinded placebo controlled study, another 35 eligible patients will be recruited and randomized into 2 study groups where 15 patients will be assigned into Group A to receive Cyto-MSC (5 × 106 MSC per kg bodyweight) and standard treatment, meanwhile another 20 patients will be assigned into Group B to receive Placebo and standard treatment.Cyto-MSC or Placebo will be administered at Day 1 and Day 4. Another infusion of Cyto-MSC or Placebo will be given at Day 7 if the patient shows no or partial response based on GVHD grading criteria. All patients will be assessed up until 6 months follow-up which include medical history, clinical and physical evaluations, pathology investigations, biomarkers and immune cell subsets analysis, as well as quality of life questionnaires.
Source: Cytotherapy - Category: Cytology Source Type: research