A Phase 2 Study Using Placenta Derived Decidual Stromal Cells for Graft Versus Host Disease

NCT ID: NCT02172924

Last Updated: 2014-11-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2019-12-31

Brief Summary

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The purpose of this study is to evaluate the safety and efficacy using decidual stromal cell therapy for graft versus host disease after allogeneic hematopoietic stem cell transplantation. The hypothesis to be tested is that the cells are safe to infuse and that they have a positive clinical effect.

Detailed Description

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Patients with GVHD grade 2-4, will receive decidual stromal cells at approximately 1x10\^6 cells/kg at one or more occasions at weekly intervals dependent on clinical response.

Conditions

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Graft vs Host Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Early Decidual Stromal Cells

Patients with therapy-refractory GVHD and on calcineurin inhibitor and high dose corticosteroids since no more than 7 days will be given Decidual Stromal Cell therapy.

Group Type ACTIVE_COMPARATOR

Early Decidual stromal cell therapy

Intervention Type BIOLOGICAL

Intervention given within 7 days after corticosteroids.

Late Decidual Stromal Cells

Patients with therapy-refractory GVHD and on calcineurin inhibitor and high dose corticosteroids for longer than 7 days will be given Decidual Stromal Cell therapy.

Group Type ACTIVE_COMPARATOR

Late Decidual stromal cell therapy

Intervention Type BIOLOGICAL

Intervention given after 7 days after corticosteroids.

Interventions

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Early Decidual stromal cell therapy

Intervention given within 7 days after corticosteroids.

Intervention Type BIOLOGICAL

Late Decidual stromal cell therapy

Intervention given after 7 days after corticosteroids.

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Acute graft versus host disease grade 2-4 or therapy resistant chronic graft versus host disease.
* Are on calcineurin inhibitor and high dose corticosteroids.

Exclusion Criteria

* Terminally ill patients
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Karolinska University Hospital

OTHER

Sponsor Role collaborator

Karolinska Institutet

OTHER

Sponsor Role lead

Responsible Party

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Olle Ringdén

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Olle Ringdén, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Locations

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Karolinska Institutet

Stockholm, , Sweden

Site Status

Countries

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Sweden

Central Contacts

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Olle Ringdén, MD, PhD

Role: CONTACT

+46858582672

Helen Kaipe, PhD

Role: CONTACT

+46700901052

Facility Contacts

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Olle Ringdén, MD, PhD

Role: primary

+858582672

Other Identifiers

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DSCGVHD001

Identifier Type: -

Identifier Source: org_study_id