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

University Health Network, Toronto

Status and phase: Completed; Phase 2

Conditions: Allogeneic Hematopoietic Cell Transplant; Steroid Refractory GVHD; Myelodysplastic/Myeloproliferative Neoplasm

Treatments: Biological: Decidual stromal cells (DSC)

Study type: Interventional

Funder types: Other

Identifiers

NCT04926194

DSC-SR

Details and patient eligibility

About

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).

Enrollment: 1 patient

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1 participants in 1 patient group

Patient with MDS/MPN

Experimental group

Description:

DSCs will be given 1 × 10\^6 cells per kilogram of participant's body weight intravenously, administered once per week up to a maximum of six weeks depending on the clinical response.

Treatment:

Biological: Decidual stromal cells (DSC)