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

Karolinska Institute

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Graft vs Host Disease

Treatments: Biological: Decidual Stromal Cells thawed in plasma; Biological: Decidual Stromal Cells thawed in human albumin

Study type: Interventional

Funder types: Other

Identifiers

NCT02172937

DSCGVHD002

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 50 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

None.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Decidual Stromal Cells as last line treatment

Experimental group

Description:

Patients with therapy-refractory GVHD and on calcineurin inhibitor and high dose corticosteroids without any signs of improvement will be given DSCs to evaluate a possible effect. DSCs will be thawed from the freezer in plasma.

Treatment:

Biological: Decidual Stromal Cells thawed in plasma

Decidual Stromal Cells

Active Comparator group

Description:

Patients with therapy-refractory GVHD and on calcineurin inhibitor and high dose corticosteroids will be given DSCs as early as possible at one or more occasions at weekly intervals dependent on clinical response. DSCs will be thawed from the freezer in plasma.

Treatment:

Biological: Decidual Stromal Cells thawed in human albumin