Clinical Trial: A Phase 2 Study Using Placenta Derived Decidual Stromal Cells for Graft Versus Host Disease
Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional
Official Title: A Phase 2 Study Using Placenta Derived Decidual Stromal Cells for Graft Versus Host Disease
Brief 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 Summary: 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.
Sponsor: Karolinska Institutet
Current Primary Outcome: Actuarial survival at one year after onset of graft versus host disease [ Time Frame: 12 months after inclusion ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Response at 28 days after onset of graft versus host disease [ Time Frame: 28 days after inclusion ]
- Side effects [ Time Frame: Up to 6 months after inclusion ]
- Incidence of severe infections [ Time Frame: Up to 12 months after inclusion ]
- Disease free survival [ Time Frame: 12 months after inclusion ]
Original Secondary Outcome: Same as current
Information By: Karolinska Institutet
Dates:
Date Received: June 17, 2014
Date Started: January 2017
Date Completion: December 2019
Last Updated: November 8, 2014
Last Verified: November 2014
