A Pilot Study Using Placenta Derived Decidual Stromal Cells for Hemorrhagic Cystitis

Karolinska Institute

Status and phase: Completed; Phase 2; Phase 1

Conditions: Hemorrhagic Cystitis

Treatments: Biological: Decidual Stromal Cell therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02172963

DSCHC001

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and efficacy using placenta derived decidual stromal cell therapy for hemorrhagic cystitis after allogeneic hematopoietic cell transplantation. It is hypothesized that the decidual stromal cell therapy is safe to infuse and that they have a positive clinical effect.

Full description

Patients with grade 2-4 hemorrhagic cystitis will receive decidual stromal cell therapy at approximately 1-2x10^6 cells/kg once or at weekly intervals dependent on clinical effect.

Enrollment: 12 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Hemorrhagic cystitis grade 2-4

Exclusion criteria

• Urinary urge without macroscopic hematuria or clots

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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12 participants in 1 patient group

Decidual Stromal Cell therapy for Hemorrhagic Cystitis

Experimental group

Treatment:

Biological: Decidual Stromal Cell therapy