Mesenchymal stromal cells for the treatment of acute graft versus host disease

Not Applicable

Completed

• Conditions: Steroid refractory acute graft versus host disease after hematopoietic stem cell transplantation or donor lymphocyte infusion; Injury, Occupational Diseases, Poisoning; Bone-marrow transplant rejection

• Registration Number: ISRCTN18091201
• Lead Sponsor: Hematology and Oncology Research Association of Lithuania (Hematologijos ir onkologijos tyreju asociacija LTU)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-08-18
• Study Completion: 2023-12-31
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 45

Inclusion Criteria

1. Steroid refractory acute graft versus host disease after hematopoietic stem cell transplantation
2. 18 years old and older
3. Signed informed consent form

Exclusion Criteria

Does not meet inclusion criteria

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Overall response rate (ORR) to mesenchymal stromal cells, defined as complete response (CR) or partial response (PR) of acute graft versus host disease, measured at D7, D14, D21, D28, D35, D42, D49, D56, 3 months

Secondary Outcome Measures

Name	Time	Method
Measured at D7, D14, D21, D28, D35, D42, D49, D56, 3 months, 6 months, 9 months, 12 months, 18 months, 24 months and each year thereafter:<br>1. Overall survival (OS), defined as time from the start of treatment until death from any cause<br>2. Event free survival, defined as time from the start of treatment until the following events (whichever occurs first): death, hematologic malignancy relapse, no PR/CR by 3 months since the study entry, aGVHD relapse after PR/CR requiring next line treatment, progression to extensive chronic GVHD