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Completed

NCT Number: NCT02172963

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

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.

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Key information

Conditions

Hemorrhagic Cystitis Cystitis Cystitis, Hemorrhagic Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Urinary Bladder Diseases Urogenital Diseases Urologic Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Karolinska Institutet

Stockholm, 14186, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Hemorrhagic cystitis grade 2-4

Exclusion criteria

  • Urinary urge without macroscopic hematuria or clots

Treatment and study plan

Decidual Stromal Cell therapy

Biological

Intravenous injection with placenta derived Decidual Stromal Cells. 1-2x10^6 cells/kg.

Primary outcomes

  1. Response at day 28 after onset of hemorrhagic cystitis

    Time frame: 28 days after inclusion

    Disappearance of macroscopic hematuria.

Secondary outcomes

  1. Actuarial survival at one year after onset of hemorrhagic cystitis

    Time frame: One year after inclusion

  2. Time to disappearance of pain or urges

    Time frame: Up to 6 months after inclusion

  3. Time to disappearance of microscopic hematuria

    Time frame: Up to 84 days after inclusion

  4. Transplant related mortality

    Time frame: Up to one year after inclusion

    All mortality except for relapse

  5. Incidence of severe infections

    Time frame: Up to one year after inclusion

    Incidence of severe bacterial, viral or fungal infections.

  6. Incidence of graft versus host disease

    Time frame: Up to one year after inclusion

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jun 24, 2014
Registry last updated
Jun 24, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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