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

Phase 2

Completed

• Conditions: Steroid Refractory GVHD; Myelodysplastic/Myeloproliferative Neoplasm; Allogeneic Hematopoietic Cell Transplant
• Interventions: Biological: Decidual stromal cells (DSC)

• Registration Number: NCT04926194
• Lead Sponsor: University Health Network, Toronto

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2021-03-11
• Study First Submitted: 2021-06-08
• Study First Submitted QC: 2021-06-08
• Primary Completion: 2021-06-09
• Study Completion: 2021-06-09
• Study First Posted: 2021-06-15
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-08
• Last Update Posted: 2023-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patient with MDS/MPN	Decidual stromal cells (DSC)	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.

Primary Outcome Measures

Name	Time	Method
Eastern Cooperative Oncology Group Performance Status Score	6 weeks
Bilirubin levels	6 weeks
C-reactive protein levels	6 weeks
Aspartate Transaminase levels	6 weeks
Alkaline phosphatase levels	6 weeks
Karnofsky Performance Score	6 weeks
Graft-Versus-Host Disease Severity	6 weeks	By grade
Alanine aminotransferase levels	6 weeks

Trial Locations

Locations (1)

Princess Margaret Cancer Centre; 🇨🇦 Toronto, Ontario, Canada