Allogenic Bone Marrow Mesenchymal Stem Cells Infusion in Patients With Steroid-refractory GVHD
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|ClinicalTrials.gov Identifier: NCT02824653|
Recruitment Status : Completed
First Posted : July 7, 2016
Last Update Posted : January 25, 2017
|Condition or disease||Intervention/treatment||Phase|
|Graft Versus Host Disease||Biological: Mesenchymal Stem Cells||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Allogenic Bone Marrow Mesenchymal Stem Cells Infusion in Patients With Steroid-refractory GVHD- A Phase I/II Clinical Trial|
|Study Start Date :||January 2015|
|Actual Primary Completion Date :||July 2016|
|Actual Study Completion Date :||December 2016|
Experimental: Mesenchymal Stem Cells
The experimental arm is comprised of GVHD patients receiving allogenic bone marrow mesenchymal stem cells
Biological: Mesenchymal Stem Cells
Allogenic Human Bone Marrow Mesenchymal Stem Cells (ex-vivo expanded in pooled human platelet lysate)
Other Name: Allogenic Bone Marrow MSCs
- Incidence of treatment-emergent adverse events and complications [Safety and Tolerability] [ Time Frame: 4 weeks ]Safety will be evaluated by reporting any incidence of adverse event, complication and toxicity related to administration of MSCs within 4 weeks of last infusion .
- Acute GVHD-restaging [Efficacy] [ Time Frame: 4 weeks ]Efficacy of ex-vivo expanded allogenic mesenchymal stem cell infusion will be determined by organ-specific re-staging and global grading of Acute GVHD as per consensus group criteria. Response will be measured as complete response (CR), partial response (PR), stable disease(SD) and progressive disease(PD). CR:acute GVHD symptoms and signs disappear; PR:aGVHD symptoms and signs improve; SD:aGVHD symptoms and signs remain (without improvement or deterioration);PD: aGVHD symptoms and signs deteriorate.
- Chronic GVHD-restaging [Efficacy] [ Time Frame: 3 months ]Organ-specific scoring and global scoring of chronic GVHD will be done as per NIH consensus criteria of 2014. Treatment response will be measured as complete response (CR), partial response (PR), stable disease(SD) and progressive disease(PD). CR:chronic GVHD symptoms and signs disappear; PR:cGVHD symptoms and signs improve; SD:cGVHD symptoms and signs remain (without improvement or deterioration);PD: cGVHD symptoms and signs deteriorate.
- Survival analysis at six months after MSC infusion [ Time Frame: 6 months ]
Documenting patients' survival status after 6 months of receiving MSC infusion
To document relapse of hematological malignancies post-MSC infusion.
Evaluation of late infectious complications or toxicities after MSC infusion.
- Incidence free survival at six months after MSC infusion [ Time Frame: 6 months ]To document rate of GVHD recurrence in patients after MSC infusion.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02824653
|Armed Forces Bone Marrow Transplant Centre|
|Rawalpindi, Punjab, Pakistan, 46000|
|Principal Investigator:||Parvez Ahmed, FCPS, MCPS||Armed Forces Bone Marrow Transplant Centre, Rawalpindi, Pakistan|