MSC for Treatment of CMV Infection

Nanfang Hospital, Southern Medical University

Status and phase: Unknown; Phase 2

Conditions: CMV Infection; Hematological Diseases; Stem Cell Transplantation, Hematopoietic

Treatments: Biological: MSCs

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02083731

NFH-MSC-CMV-2014

Details and patient eligibility

About

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).

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 14 to 65 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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120 participants in 1 patient group

MSCs

Experimental group

Description:

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.

Treatment:

Biological: MSCs