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Completed

NCT Number: NCT04926194

Decidual Stromal Cells to Treat Graft-vs-Host Disease After Stem 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).

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Key information

Conditions

Myelodysplastic/Myeloproliferative Neoplasm Allogeneic Hematopoietic Cell Transplant Bone Marrow Diseases Hematologic Diseases Hemic and Lymphatic Diseases Myelodysplastic-Myeloproliferative Diseases Steroid Refractory GVHD

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Decidual stromal cells (DSC)

Biological

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

Primary outcomes

  1. Eastern Cooperative Oncology Group Performance Status Score

    Time frame: 6 weeks

  2. Karnofsky Performance Score

    Time frame: 6 weeks

  3. Graft-Versus-Host Disease Severity

    Time frame: 6 weeks

    By grade

  4. Aspartate Transaminase levels

    Time frame: 6 weeks

  5. Alanine aminotransferase levels

    Time frame: 6 weeks

  6. Alkaline phosphatase levels

    Time frame: 6 weeks

  7. Bilirubin levels

    Time frame: 6 weeks

  8. C-reactive protein levels

    Time frame: 6 weeks

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Official study 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

Acronym: DSC-SR

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jun 15, 2021
Registry last updated
Jan 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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