NCT02172963

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Nov 2011

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 18, 2014

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 24, 2014

Completed
Last Updated

June 24, 2014

Status Verified

June 1, 2014

Enrollment Period

2.1 years

First QC Date

June 18, 2014

Last Update Submit

June 23, 2014

Conditions

Hemorrhagic Cystitis

Keywords

Stem Cell TransplantationDecidual Stromal Cells

Outcome Measures

Primary Outcomes (1)

  • Response at day 28 after onset of hemorrhagic cystitis

    Disappearance of macroscopic hematuria.

    28 days after inclusion

Secondary Outcomes (6)

  • Actuarial survival at one year after onset of hemorrhagic cystitis

    One year after inclusion

  • Time to disappearance of pain or urges

    Up to 6 months after inclusion

  • Time to disappearance of microscopic hematuria

    Up to 84 days after inclusion

  • Transplant related mortality

    Up to one year after inclusion

  • Incidence of severe infections

    Up to one year after inclusion

  • +1 more secondary outcomes

Study Arms (1)

Decidual Stromal Cell therapy for Hemorrhagic Cystitis

EXPERIMENTAL
Biological: Decidual Stromal Cell therapy

Interventions

Decidual Stromal Cell therapyBIOLOGICAL

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

Decidual Stromal Cell therapy for Hemorrhagic Cystitis

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Hemorrhagic cystitis grade 2-4

You may not qualify if:

  • Urinary urge without macroscopic hematuria or clots

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska Institutet

Stockholm, 14186, Sweden

Location

MeSH Terms

Conditions

Cystitis, Hemorrhagic

Condition Hierarchy (Ancestors)

CystitisUrinary Bladder DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Olle Ringdén, MD, PhD

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 18, 2014

First Posted

June 24, 2014

Study Start

November 1, 2011

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

June 24, 2014

Record last verified: 2014-06

Locations

SE(1)