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NCT04926194 Clinical Trial

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

Myelodysplastic/Myeloproliferative Neoplasm Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04926194
Other study ID # DSC-SR
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date March 11, 2021
Est. completion date June 9, 2021

Study information
Verified date January 2023
Source University Health Network, Toronto
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).

Recruitment information / eligibility
Status Completed
Enrollment 1
Est. completion date June 9, 2021
Est. primary completion date June 9, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• Decidual stromal cells (DSC)
DSCs are isolated from donated human placenta and have been shown to have anti-inflammatory effects.

Locations
Country Name City State
Canada Princess Margaret Cancer Centre Toronto Ontario

Sponsors (1)
Lead Sponsor Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary Eastern Cooperative Oncology Group Performance Status Score 6 weeks
Primary Karnofsky Performance Score 6 weeks
Primary Graft-Versus-Host Disease Severity By grade 6 weeks
Primary Aspartate Transaminase levels 6 weeks
Primary Alanine aminotransferase levels 6 weeks
Primary Alkaline phosphatase levels 6 weeks
Primary Bilirubin levels 6 weeks
Primary C-reactive protein levels 6 weeks
See also
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Completed NCT01527045 - Donor Atorvastatin Treatment in Preventing Severe Acute GVHD After Nonmyeloablative Peripheral Blood Stem Cell Transplant in Patients With Hematological Malignancies Phase 2
Active, not recruiting NCT03289910 - Topotecan Hydrochloride and Carboplatin With or Without Veliparib in Treating Advanced Myeloproliferative Disorders and Acute Myeloid Leukemia or Chronic Myelomonocytic Leukemia Phase 2
Recruiting NCT03246906 - Comparison of Triple GVHD Prophylaxis Regimens for Nonmyeloablative or Reduced Intensity Conditioning Unrelated Mobilized Blood Cell Transplantation Phase 2
Active, not recruiting NCT00075478 - Total-Body Irradiation With or Without Fludarabine Phosphate Followed By Donor Stem Cell Transplant in Treating Patients With Hematologic Cancer Phase 3
Recruiting NCT03630991 - Edetate Calcium Disodium or Succimer in Treating Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome Undergoing Chemotherapy Phase 1
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Recruiting NCT03964506 - Hyperbaric Oxygen Therapy and Allogeneic Peripheral Blood Stem Cell (PBSC) Transplant Early Phase 1
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Completed NCT01712308 - Sotatercept in Treating Patients With Myeloproliferative Neoplasm-Associated Myelofibrosis or Anemia Phase 2
Completed NCT02257138 - Ruxolitinib Phosphate and Decitabine in Treating Patients With Relapsed or Refractory or Post Myeloproliferative Acute Myeloid Leukemia Phase 1/Phase 2