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

Sponsor

University Health Network, Toronto (Other)

Overall Status

Completed

CT.gov ID

NCT04926194

Collaborator

(none)

Enrollment

Location

Arm

2.8

Actual Duration (Months)

0.4

Patients Per Site Per Month

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Myelodysplastic/Myeloproliferative Neoplasm Steroid Refractory GVHD Allogeneic Hematopoietic Cell Transplant	Biological: Decidual stromal cells (DSC)	Phase 2

Study Design

Study Type:

Interventional

Actual Enrollment :

1 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Mar 11, 2021

Actual Primary Completion Date :

Jun 4, 2021

Actual Study Completion Date :

Jun 4, 2021

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Princess Margaret Cancer Centre	Toronto	Ontario	Canada	M5G 2M9

Sponsors and Collaborators

University Health Network, Toronto

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University Health Network, Toronto

ClinicalTrials.gov Identifier:

NCT04926194

Other Study ID Numbers:

DSC-SR

First Posted:

Jun 15, 2021

Last Update Posted:

Apr 28, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Neoplasms

Myelodysplastic Syndromes

Myeloproliferative Disorders

Myelodysplastic-Myeloproliferative Diseases

Graft vs Host Disease

Study Results

No Results Posted as of Apr 28, 2022