A Pilot Study Using Placenta Derived Decidual Stromal Cells for Toxicity and Inflammation With Special Focus to the Allogeneic Hematopoietic Cell Transplantation Setting

Karolinska Institute

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Stem Cell Transplantation; Inflammation; Decidual Stromal Cells; Acute Lung Injury

Treatments: Biological: Decidual stromal cell therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02175303

DSCINF001

Details and patient eligibility

About

To evaluate safety and efficacy using decidual stromal cell therapy for toxicity and inflammation, with special focus on allogeneic hematopoietic cell transplantation patients. The hypothesis to be tested is that the cells are safe to infuse and that they have an anti-inflammatory and healing effect.

Full description

Patients with toxicity, inflammation or hemorrhages will receive decidual stromal cells at approximately 1x10^6 cells/kg at one or more occasions at weekly intervals dependent on clinical response.

Enrollment: 25 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with toxicity, inflammation or hemorrhages.

Exclusion criteria

• None

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

Decidual stromal cell therapy for toxicity and inflammation

Experimental group

Description:

Patients with toxicity, inflammation or hemorrhages will receive decidual stromal cells at approximately 1x10\^6 cells/kg at one or more occasions at weekly intervals dependent on clinical response.

Treatment:

Biological: Decidual stromal cell therapy