Decidual Stromal Cells to Treat Graft-vs-Host Disease After Stem Cell Transplant for Myelodysplastic Syndrome/Myeloproliferative Neoplasm

University Health Network, Toronto1 enrolled

Overview

This is a single participant study of decidual stromal cells (DSC) for the treatment of steroid refractory graft-versus-host disease (GVHD) in a patient with myelodysplastic syndrome/myeloproliferative neoplasm (MDS/MPN).

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Myelodysplastic/Myeloproliferative Neoplasm Steroid Refractory GVHD Allogeneic Hematopoietic Cell Transplant

Interventions

Decidual stromal cells (DSC)BIOLOGICAL

DSCs are isolated from donated human placenta and have been shown to have anti-inflammatory effects.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

A single participant with myelodysplastic syndrome/myeloproliferative neoplasm located at Princess Margaret Cancer Centre who experienced steroid-refractory graft-vs-host disease after receiving an allogeneic hematopoietic cell transplant and have no standard treatment options available.

Locations (1)

Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Outcomes

Primary Outcomes

Eastern Cooperative Oncology Group Performance Status Score

Time frame: 6 weeks

Karnofsky Performance Score

Time frame: 6 weeks

Graft-Versus-Host Disease Severity

By grade

Time frame: 6 weeks

Aspartate Transaminase levels

Time frame: 6 weeks

Alanine aminotransferase levels

Time frame: 6 weeks

Alkaline phosphatase levels

Time frame: 6 weeks

Bilirubin levels

Time frame: 6 weeks

C-reactive protein levels

Time frame: 6 weeks

Data from ClinicalTrials.gov

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