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

January 8, 2023 updated by: University Health Network, Toronto

Decidual Stromal Cells (DSC) in Treatment of Steroid-Refractory Graft-vs-host Disease in a Recipient of Matched Related Donor Allogeneic Hematopoietic Cell Transplant for Myelodysplastic Syndrome/Myeloproliferative Neoplasm

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Princess Margaret Cancer Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patient with MDS/MPN
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.
Biological: Decidual stromal cells (DSC)
DSCs are isolated from donated human placenta and have been shown to have anti-inflammatory effects.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Investigators

  • Principal Investigator: Ivan Pasic, MD, Princess Margaret Cancer Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 11, 2021

Primary Completion (Actual)

June 9, 2021

Study Completion (Actual)

June 9, 2021

Study Registration Dates

First Submitted

June 8, 2021

First Submitted That Met QC Criteria

June 8, 2021

First Posted (Actual)

June 15, 2021

Study Record Updates

Last Update Posted (Estimate)

January 10, 2023

Last Update Submitted That Met QC Criteria

January 8, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DSC-SR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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