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

NCT ID: NCT04926194

Last Updated: 2023-01-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-11

Study Completion Date

2021-06-09

Brief Summary

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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

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Conditions

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Myelodysplastic/Myeloproliferative Neoplasm Steroid Refractory GVHD Allogeneic Hematopoietic Cell Transplant

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Decidual stromal cells (DSC)

Intervention Type BIOLOGICAL

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

Interventions

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Decidual stromal cells (DSC)

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

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Health Network, Toronto

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ivan Pasic, MD

Role: PRINCIPAL_INVESTIGATOR

Princess Margaret Cancer Centre

Locations

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Princess Margaret Cancer Centre

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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DSC-SR

Identifier Type: -

Identifier Source: org_study_id

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