Clinical Trial: Decidual Stromal Cells as Treatment for Acute Graft Versus Host Disease, a Phase 1-2 Study

Study Status: Recruiting
Recruit Status: Unknown status
Study Type: Interventional

Official Title: Decidual Stromal Cells as Treatment for Acute Graft Versus Host Disease

Brief Summary: The purpose of this study is to evaluate 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 1-2x10^6 cells/kg at one or more occasions dependent on clinical response.
Sponsor: Karolinska Institutet

Current Primary Outcome: Actuarial survival at six months after first DSC infusion [ Time Frame: 6 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 ]

    Response will be measured as:

    • Partial response (PR) if the patient has improved one grade in the overall GvH.
    • Complete response (CR) if the patient is free of GvH.
    • Non responder (NR) if the patient does not improve after treatment.
  • Response at 84 days after onset of graft versus host disease [ Time Frame: Up to 84 days after inclusion ]

    Response will be measured as:

    • Partial response (PR) if the patient has improved one grade in the overall GvH.
    • Complete response (CR) if the patient is free of GvH.
    • Non responder (NR) if the patient does not improve after treatment.
  • Response at 168 days after onset of graft versus host disease [ Time Frame: Up to 168 days after inclusion ]

    Response will be measured as:

    • Partial response (PR) if the patient has improved one grade in the overall GvH.
    • Complete response (CR) if the patient is free of GvH.
    • Non responder (NR) if the patient does not improve after treatment.
  • Side effects [ Time Frame: Up to 6 months after inclusion ]
    Adverse effects related to the treatment.
  • Incidence of severe infections [ Time Frame: Up to one year after inclusion ]
    Severe bacterial, viral and fungal infections.
  • Disease free survival [ Time Frame: Up to one year after inclusion ]
    Survival free from relapse.


Original Secondary Outcome: Same as current

Information By: Karolinska Institutet

Dates:
Date Received: June 17, 2014
Date Started: January 2011
Date Completion: December 2016
Last Updated: November 8, 2014
Last Verified: November 2014