Mesenchymal Stem Cell Infusion in Haploidentical Hematopoietic Stem Cell Transplantation in Patients With Hematological Malignancies
1 other identifier
interventional
6
1 country
1
Brief Summary
Mesenchymal stem cells (MSCs) have been used in the treatment and prevention of graft-versus host disease (GVHD). In this study the investigators aim to present the efficacy of mesenchymal stem cells in graft versus host disease prophylaxis and effect of engraftment in haploidentical recipients. Forty patients aged older than 18 who have indications for haploidentical hematopoietic stem cell transplantation will be included to the study. MSCs will be isolated from donor bone marrows and infused to the patient after conditioning regimen on day +6. If the haploidentical transplantation results improve with MSCs treatment it would be possible to ameliorate the problem of HLA-matched donor paucity in Turkey and prefer haploidentical donors.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Oct 2014
Typical duration for phase_3
1 active site
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
October 1, 2014
CompletedFirst Submitted
Initial submission to the registry
November 13, 2015
CompletedFirst Posted
Study publicly available on registry
April 10, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2017
CompletedJanuary 10, 2018
January 1, 2018
2.8 years
November 13, 2015
January 8, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Effect of mesenchymal stem cells on overall survival in haploidentical stem cell transplantation
36 months
Secondary Outcomes (2)
Effect of mesenchymal stem cells on graft versus host disease incidence in haploidentical stem cell transplantation
36 months
Effect of mesenchymal stem cells on graft failure incidence in haploidentical stem cell transplantation
36 months
Study Arms (1)
Mesenchymal Stem Cell in Haplo-SCT
EXPERIMENTALAfter preferred conditioning regimen for the patient, cyclophosphamide 50 mg/kg/day will be administered at +3 and +4 post transplant day. At +6 post transplant day, 2-8x10\^8 cell/kg mesenchymal stem cells will be infused.
Interventions
After preferred conditioning regimen for the patient, cyclophosphamide 50 mg/kg/day will be administered at +3 and +4 post transplant day. At +6 post transplant day, 2-8x10\^8 cell/kg mesenchymal stem cells will be infused.
After preferred conditioning regimen for the patient, cyclophosphamide 50 mg/kg/day will be administered at +3 and +4 post transplant day.
Eligibility Criteria
You may qualify if:
- Diagnosed with haematological malignancy
- Indication of haploidentical hematopoietic stem cell transplantation
- No restrictions for transplantation
You may not qualify if:
- Any restriction for transplantation
- No indication of haploidentical hematopoietic stem cell transplantation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ankara University School of Medicine Department of Hematology
Ankara, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD, Department of Hematology, Clinical Professor
Study Record Dates
First Submitted
November 13, 2015
First Posted
April 10, 2017
Study Start
October 1, 2014
Primary Completion
July 1, 2017
Study Completion
October 1, 2017
Last Updated
January 10, 2018
Record last verified: 2018-01