NCT02172924

A Phase 2 Study Using Placenta Derived Decidual Stromal Cells for Graft Versus Host Disease

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Karolinska Institutet · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety and efficacy using decidual stromal cell therapy for graft versus host disease after allogeneic hematopoietic stem cell transplantation. The hypothesis to be tested is that the cells are safe to infuse and that they have a positive clinical effect.

Detailed description

Patients with GVHD grade 2-4, will receive decidual stromal cells at approximately 1x10\^6 cells/kg at one or more occasions at weekly intervals dependent on clinical response.

Conditions

• Graft vs Host Disease

Interventions

Type	Name	Description
BIOLOGICAL	Early Decidual stromal cell therapy	Intervention given within 7 days after corticosteroids.
BIOLOGICAL	Late Decidual stromal cell therapy	Intervention given after 7 days after corticosteroids.

Timeline

• Start date: 2017-01-01
• Primary completion: 2019-12-01
• Completion: 2019-12-01
• First posted: 2014-06-24
• Last updated: 2014-11-11

Locations

1 site across 1 country: Sweden