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

Phase 1

• Conditions: Graft vs Host Disease
• Interventions: Biological: Early Decidual stromal cell therapy; Biological: Late Decidual stromal cell therapy

• Registration Number: NCT02172924
• Lead Sponsor: Karolinska Institutet

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 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.

Study Timeline

• Study First Submitted: 2014-06-17
• Study First Submitted QC: 2014-06-23
• Study First Posted: 2014-06-24
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-08
• Last Update Posted: 2014-11-11
• Study Start: 2017-01
• Primary Completion: 2019-12
• Study Completion: 2019-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Acute graft versus host disease grade 2-4 or therapy resistant chronic graft versus host disease.
• Are on calcineurin inhibitor and high dose corticosteroids.

Exclusion Criteria

• Terminally ill patients

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Early Decidual Stromal Cells	Early Decidual stromal cell therapy	Patients with therapy-refractory GVHD and on calcineurin inhibitor and high dose corticosteroids since no more than 7 days will be given Decidual Stromal Cell therapy.
Late Decidual Stromal Cells	Late Decidual stromal cell therapy	Patients with therapy-refractory GVHD and on calcineurin inhibitor and high dose corticosteroids for longer than 7 days will be given Decidual Stromal Cell therapy.

Primary Outcome Measures

Name	Time	Method
Actuarial survival at one year after onset of graft versus host disease	12 months after inclusion

Secondary Outcome Measures

Name	Time	Method
Response at 28 days after onset of graft versus host disease	28 days after inclusion
Incidence of severe infections	Up to 12 months after inclusion
Disease free survival	12 months after inclusion
Side effects	Up to 6 months after inclusion

Trial Locations

Locations (1)

Karolinska Institutet; 🇸🇪 Stockholm, Sweden