Stem Cell Transplantation, Hematopoietic, CMV Infection, Hematological Diseases
Conditions
Keywords
CMV infection, Mesenchymal Stem Cells, Allogeneic hematopoietic stem cell transplantation
Brief summary
The purpose of this study is to evaluate the efficacy of mesenchymal stem cells (MSC) in the treatment of refractory cytomegalovirus (CMV) infection after allogeneic hematopoietic stem cell transplantation (allo-HSCT).
Detailed description
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.
Interventions
BIOLOGICALMSCs
Sponsors
Academy Military Medical Science, China
Peking University People's Hospital
Sun Yat-sen University
Guangdong Provincial People's Hospital
Guangzhou General Hospital of Guangzhou Military Command
Third Affiliated Hospital, Sun Yat-Sen University
Shanghai Zhongshan Hospital
Nanfang Hospital, Southern Medical University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
14 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* A patient age of 14-65 years * Refractory CMV infection or CMV-associated diseases * Subjects (or their legally acceptable representatives) must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study
Exclusion criteria
* Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood pressure) * Patients with any conditions not suitable for the trial (investigators' decision)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of Participants achieved complete remission of CMV infection | 1 year |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Serious and Non-Serious Adverse Events | 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. |
Countries
China
Contacts
Primary ContactRen Lin, MD.
Outcome results
None listed