NCT04926194

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Mar 2021

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 11, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 8, 2021

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 9, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 9, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 15, 2021

Completed
Last Updated

January 10, 2023

Status Verified

January 1, 2023

Enrollment Period

3 months

First QC Date

June 8, 2021

Last Update Submit

January 8, 2023

Conditions

Myelodysplastic/Myeloproliferative NeoplasmSteroid Refractory GVHDAllogeneic Hematopoietic Cell Transplant

Outcome Measures

Primary Outcomes (8)

  • Eastern Cooperative Oncology Group Performance Status Score

    6 weeks

  • Karnofsky Performance Score

    6 weeks

  • Graft-Versus-Host Disease Severity

    By grade

    6 weeks

  • 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

Study Arms (1)

Patient with MDS/MPN

EXPERIMENTAL

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)

Interventions

Decidual stromal cells (DSC)BIOLOGICAL

DSCs are isolated from donated human placenta and have been shown to have anti-inflammatory effects.

Patient with MDS/MPN

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Conditions

Myelodysplastic-Myeloproliferative Diseases

Condition Hierarchy (Ancestors)

Bone Marrow DiseasesHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • Ivan Pasic, MD

    Princess Margaret Cancer Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 8, 2021

First Posted

June 15, 2021

Study Start

March 11, 2021

Primary Completion

June 9, 2021

Study Completion

June 9, 2021

Last Updated

January 10, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)