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

Karolinska Institute

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Graft vs Host Disease

Treatments: Biological: Late Decidual stromal cell therapy; Biological: Early Decidual stromal cell therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02172924

DSCGVHD001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

---

30 participants in 2 patient groups

Early Decidual Stromal Cells

Active Comparator group

Description:

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.

Treatment:

Biological: Early Decidual stromal cell therapy

Late Decidual Stromal Cells

Active Comparator group

Description:

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.

Treatment:

Biological: Late Decidual stromal cell therapy