Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Academy Military Medical Science, China | INDUSTRY |
| Peking University People's Hospital | OTHER |
| Sun Yat-sen University | OTHER |
| Guangdong Provincial People's Hospital |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MSCs | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MSCs | Biological |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants achieved complete remission of CMV infection | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with Serious and Non-Serious Adverse Events | 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ren Lin, MD. | Contact | +86-020-61641613 | lansinglinren@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Qifa Liu, MD. | Nanfang Hospital, Southern Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Hematology,Nanfang Hospital, Southern Medical University | Recruiting | Guangzhou | Guangdong | 510515 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21242993 | Background | Meisel R, Brockers S, Heseler K, Degistirici O, Bulle H, Woite C, Stuhlsatz S, Schwippert W, Jager M, Sorg R, Henschler R, Seissler J, Dilloo D, Daubener W. Human but not murine multipotent mesenchymal stromal cells exhibit broad-spectrum antimicrobial effector function mediated by indoleamine 2,3-dioxygenase. Leukemia. 2011 Apr;25(4):648-54. doi: 10.1038/leu.2010.310. Epub 2011 Jan 18. | |
| 18587440 |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003586 | Cytomegalovirus Infections |
| D006402 | Hematologic Diseases |
| ID | Term |
|---|---|
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
Not provided
Not provided
| OTHER |
| Guangzhou General Hospital of Guangzhou Military Command | OTHER |
| Third Affiliated Hospital, Sun Yat-Sen University | OTHER |
| Shanghai Zhongshan Hospital | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
| up to 1 year |
| Background |
| Ljungman P, de la Camara R, Cordonnier C, Einsele H, Engelhard D, Reusser P, Styczynski J, Ward K; European Conference on Infections in Leukemia. Management of CMV, HHV-6, HHV-7 and Kaposi-sarcoma herpesvirus (HHV-8) infections in patients with hematological malignancies and after SCT. Bone Marrow Transplant. 2008 Aug;42(4):227-40. doi: 10.1038/bmt.2008.162. Epub 2008 Jun 30. |
| D006425 |
| Hemic and Lymphatic Diseases |