MSC for Treatment of cGVHD After Allo-HSCT

Nanfang Hospital, Southern Medical University152 enrolled

Overview

The purpose of this study is to evaluate the efficacy of mesenchymal stem cells in patients with chronic graft-versus-host disease.

Allogeneic hematopoietic stem cell transplantation(allo-HSCT) can cure many hematologic diseases. Although great progress has been made in the prevention and treatment of side effects associated with transplantation,chronic graft-versus-host disease(cGVHD) remains an important complication that occurs in about 50% patients. The mortality of cGVHD and its complication could reach up to 50%,and cGVHD seriously influence the quality of life. At present, the first line treatment of cGVHD remains in discussion. Mesenchymal stem cells (MSCs) are a form of multipotent adult stem cells that can be isolated from bone marrow (BM), adipose tissue, and cord blood. Clinical applications of human MSCs are evolving rapidly with goals of improving hematopoietic engraftment, preventing and treating GVHD after allo-HSCT and so on. However, the efficacy of treatment of cGVHD remains undetermined. In the present study, the investigators will prospectively evaluate the efficacy and safety of ex-vivo-expanded MSCs in treating patients with cGVHD.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

152

Conditions

Chronic Graft-versus-host Disease

Interventions

Mesenchymal stem cellsBIOLOGICAL

Mesenchymal stem cells (MSCs) will be intravenously infused via a central venous catheter(at a dose of 1×10\^6 cells/kg, over 15 mins) weekly. MSCs will be administrated for 8 doses.

GlucocorticoidsDRUG

Glucocorticoids (i.e. Methylprednisolone) will be used with an initial dose of 1mg/kg.

cyclosporineDRUG

Cyclosporine (CsA) will be used with an initial dose of 2.5mg/kg/d and adjusted according to the concentration of CsA. The targeted concentration is 200-300 ng/Ml.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * A patient age of 18-65 years * Recipients of allogeneic hematopoietic stem cell transplantation Patients with moderate/ severe cGVHD without systemic treatment * 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) * Primary disease relapse * Expected lifetime less than 3 months * Patients with any conditions not suitable for the trial (investigators' decision)

Locations (1)

Department of Hematology,Nanfang Hospital, Southern Medical University

Guangzhou, Guangdong, China

RECRUITING

Outcomes

Primary Outcomes

ORR

Overall response rate （ORR）includes complete response (CR) and part response (PR).

Time frame: 12 weeks after the first dose of MSCs