Back to resultsDecidual Stromal Cells to Treat Graft-vs-Host Disease After Stem Cell Transplant for Myelodysplastic Syndrome/Myeloproliferative Neoplasm (DSC-SR)
Primary Purpose
Myelodysplastic/Myeloproliferative Neoplasm, Steroid Refractory GVHD, Allogeneic Hematopoietic Cell Transplant
Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Decidual stromal cells (DSC)
Sponsored by
About this trial
This is an interventional treatment trial for Myelodysplastic/Myeloproliferative Neoplasm
Eligibility 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.
Sites / Locations
- Princess Margaret Cancer Centre
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patient with MDS/MPN
Arm 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.
Outcomes
Primary Outcome Measures
Eastern Cooperative Oncology Group Performance Status Score
Karnofsky Performance Score
Graft-Versus-Host Disease Severity
By grade
Aspartate Transaminase levels
Alanine aminotransferase levels
Alkaline phosphatase levels
Bilirubin levels
C-reactive protein levels
Secondary Outcome Measures
Full Information
NCT ID
NCT04926194
First Posted
June 8, 2021
Last Updated
January 8, 2023
Sponsor
University Health Network, Toronto
1. Study Identification
Unique Protocol Identification Number
NCT04926194
Brief Title
Decidual Stromal Cells to Treat Graft-vs-Host Disease After Stem Cell Transplant for Myelodysplastic Syndrome/Myeloproliferative Neoplasm
Acronym
DSC-SR
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
March 11, 2021 (Actual)
Primary Completion Date
June 9, 2021 (Actual)
Study Completion Date
June 9, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myelodysplastic/Myeloproliferative Neoplasm, Steroid Refractory GVHD, Allogeneic Hematopoietic Cell Transplant
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Patient with MDS/MPN
Arm Type
Experimental
Arm 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.
Intervention Type
Biological
Intervention Name(s)
Decidual stromal cells (DSC)
Intervention Description
DSCs are isolated from donated human placenta and have been shown to have anti-inflammatory effects.
Primary Outcome Measure Information:
Title
Eastern Cooperative Oncology Group Performance Status Score
Time Frame
6 weeks
Title
Karnofsky Performance Score
Time Frame
6 weeks
Title
Graft-Versus-Host Disease Severity
Description
By grade
Time Frame
6 weeks
Title
Aspartate Transaminase levels
Time Frame
6 weeks
Title
Alanine aminotransferase levels
Time Frame
6 weeks
Title
Alkaline phosphatase levels
Time Frame
6 weeks
Title
Bilirubin levels
Time Frame
6 weeks
Title
C-reactive protein levels
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ivan Pasic, MD
Organizational Affiliation
Princess Margaret Cancer Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Princess Margaret Cancer Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Decidual Stromal Cells to Treat Graft-vs-Host Disease After Stem Cell Transplant for Myelodysplastic Syndrome/Myeloproliferative Neoplasm
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