MSC for Treatment of CMV Infection
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|ClinicalTrials.gov Identifier: NCT02083731|
Recruitment Status : Unknown
Verified January 2015 by Qifa Liu, Nanfang Hospital of Southern Medical University.
Recruitment status was: Recruiting
First Posted : March 11, 2014
Last Update Posted : January 7, 2015
|Condition or disease||Intervention/treatment||Phase|
|Stem Cell Transplantation, Hematopoietic CMV Infection Hematological Diseases||Biological: MSCs||Phase 2|
Viral infections are common complications after allo-HSCT. With wide use of HLA-mismatch, unrelated and cord blood donors as alternative sources of hematopoietic stem cells, and anti-thymocyte globulin (ATG) as the standard prophylaxis of graft versus host disease (GVHD) in HLA-mismatch and unrelated donor transplantation, allo-HSCT recipients are at increasing risk for viral infections.
Till now, CMV remains one of the most important viruses and causes of death in the recipients of allo-HSCT. Approximately 75% of CMV-seropositive recipients develop CMV reactivation, and 20-30% of these patients develop CMV disease without intervention. Ganciclovir is the first-line treatment of CMV diseases. However, bone marrow suppression, which is the main and common side effect, limits the utility of ganciclovir in allo-HSCT recipients. Besides, ganciclovir and other antiviral agents resistance has been reported up to 28%. Since it has been known that specific immune response to CMV is important to control reactivation, CMV-specific CTL has been used in prophylaxis and treatment of CMV viremia in several studies. However, the production of CTL requires time. Mesenchymal stem cells (MSC) are a form of multipotent adult stem cells that can be isolated from bone marrow (BM), adipose tissue, and cord blood. In vivo experiment showed that MSCs have antimicrobial activity.
In this trial, we will use MSCs in the recipients with refractory CMV infections.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||120 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Mesenchymal Stem Cells for Treatment of CMV Infection After Hematopoietic Stem Cell Transplant|
|Study Start Date :||January 2014|
|Estimated Primary Completion Date :||January 2016|
|Estimated Study Completion Date :||January 2017|
MSCs will be used to treat refractory CMV infection or CMV-associated diseases. MSCs will be intravenously infused at a dose of 1×10^6 cells/kg. If anticipates do not attain the complete remission standards within 14d, a second course of the same treatment will be given.
- Percentage of Participants achieved complete remission of CMV infection [ Time Frame: 1 year ]
- Number of Participants with Serious and Non-Serious Adverse Events [ Time Frame: up to 1 year ]Adverse Events include GVHD, primary underlying disease relapse and any other side effects. Side effects of treatment includes acute toxicity and late side effects. Acute toxicity principally involves the heart,live and kidney. Late toxic side effects involves principally the development of secondary tumors and relapse of the primary disease.
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): NCT02083731
|Contact: Ren Lin, MD.||+firstname.lastname@example.org|
|Department of Hematology,Nanfang Hospital, Southern Medical University||Recruiting|
|Guangzhou, Guangdong, China, 510515|
|Contact: Ren Lin +86-020-61641613 email@example.com|
|Principal Investigator:||Qifa Liu, MD.||Nanfang Hospital of Southern Medical University|