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A Double Blind Randomized Study Using Placenta Derived Decidual Stromal Cells for Hemorrhagic Cystitis

NCT02174536 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2014-06-25

No results posted yet for this study

Summary

A prospective double blind randomized study comparing placenta derived decidual stromal cells with placebo for hemorrhagic cystitis after allogeneic hematopoietic cell transplantation. It is hypothesized that the decidual stromal cell therapy will be superior to placebo.

Conditions

  • Hemorrhagic Cystitis
  • Stem Cell Transplantation
  • Decidual Stromal Cells

Interventions

BIOLOGICAL

Decidual stromal cells

Decidual stromal cells (approximately 1x10\^6 cells/kg) will be infused intravenously.

BIOLOGICAL

Placebo

Sponsors & Collaborators

Principal Investigators

  • Olle Ringdén, MD, PhD · Karolinska Institutet

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-03-31
Primary Completion
2016-12-31
Completion
2016-12-31

Countries

  • Sweden

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02174536 on ClinicalTrials.gov