NCT04692376

MSC for Treatment of cGVHD After Allo-HSCT

Mesenchymal Stem Cell for Treatment of Chronic Graft-versus-host Disease After Allogenetic Hematopoietic Stem Cell Transplantation

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 152 (estimated)
• Sponsor: Nanfang Hospital, Southern Medical University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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.

Conditions

• Chronic Graft-versus-host Disease

Interventions

Type	Name	Description
BIOLOGICAL	Mesenchymal stem cells	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.
DRUG	Glucocorticoids	Glucocorticoids (i.e. Methylprednisolone) will be used with an initial dose of 1mg/kg.
DRUG	cyclosporine	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.

Timeline

• Start date: 2021-01-10
• Primary completion: 2022-12-31
• Completion: 2023-06-30
• First posted: 2020-12-31
• Last updated: 2020-12-31

Locations

1 site across 1 country: China