NCT00823316

Safety and Efficacy Study of Umbilical Cord Blood-Drived Mesenchymal Stem Cells to Promote Engraftment of Unrelated Hematopoietic Stem Cell Transplantation

Phase 1/2 Study of Umbilical Cord Blood-Drived Mesenchymal Stem Cells Infusion for Promotion of Engraftment and Prevention of an Graft Rejection and Graft-versus-Host Disease After Unrelated Hematopoietic Stem Cell Transplantation.

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Medipost Co Ltd. · Industry
• Sex: All
• Age: 2 Years – 19 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety and efficacy of PROMOSTEM (human umbilical cord blood-derived mesenchymal stem cells) at a dose of 1 and 5x1,000,000 hMSC/kg in subject for the promotion of an engraftment and prevention of graft rejection and Graft-Versus-Host Disease after unrelated hematopoietic stem cell transplantation for children with acute leukemia.

Detailed description

* Hematopoietic stem cell transplantation (HSCT) is a procedure in which progenitor cells capable of reconstituting normal bone marrow function are administered to a patient. This procedure has been used to treat adults and children with life-threatening hematological malignancies and congenital immunodeficiency disorders. * In HSCT, therapeutic goal is an elimination of disease and enrichment of regenerating capacity to achieve engraftments resulting in continued generation of functional blood elements from the engrafted living cells. Transplantation of unrelated hematopoietic stem cells originating either from adult bone marrow or from peripheral blood often leads to graft-versus host-disease (GvHD), opportunistic infections and graft failure after transplantation. * In HSCT, MSC have been used as a therapy for GvHD and other complications. The aim of MSC infusions in HSCT is to use the cells' immunomodulatory effects to promote engraftment and to reduce the immunological reactions giving rise to GvHD. * There is a growing interest in co-transplantation of MSC and HSC to improve the donor outcome in the unrelated HSCT condition.

Conditions

• Acute Leukemia

Interventions

Type	Name	Description
BIOLOGICAL	Human umbilical cord blood-derived mesenchymal stem cells	1x1,000,000 hMSC/kg, IV after unrelated HSCT
BIOLOGICAL	Human umbilical cord blood-derived mesenchymal stem cells	5x1,000,000 hMSC/kg, IV after unrelated HSCT

Timeline

• Start date: 2008-08-01
• Primary completion: 2010-02-01
• Completion: 2010-02-01
• First posted: 2009-01-15
• Last updated: 2012-04-23

Locations

1 site across 1 country: South Korea