A Pilot Study Using Placenta Derived Decidual Stromal Cells for Toxicity and Inflammation With Special Focus to the Allogeneic Hematopoietic Cell Transplantation Setting

NCT ID: NCT02175303

Last Updated: 2014-06-26

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

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2017-12-31

Brief Summary

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To evaluate safety and efficacy using decidual stromal cell therapy for toxicity and inflammation, with special focus on allogeneic hematopoietic cell transplantation patients. The hypothesis to be tested is that the cells are safe to infuse and that they have an anti-inflammatory and healing effect.

Detailed Description

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Patients with toxicity, inflammation or hemorrhages 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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Acute Lung Injury Decidual Stromal Cells Stem Cell Transplantation Inflammation

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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Decidual stromal cell therapy for toxicity and inflammation

Patients with toxicity, inflammation or hemorrhages will receive decidual stromal cells at approximately 1x10\^6 cells/kg at one or more occasions at weekly intervals dependent on clinical response.

Group Type EXPERIMENTAL

Decidual stromal cell therapy

Intervention Type BIOLOGICAL

Decidual stromal cells from placenta will be infused intravenously at approximately 1x10\^6 cells/kg at one or more occasions at weekly intervals.

Interventions

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Decidual stromal cell therapy

Decidual stromal cells from placenta will be infused intravenously at approximately 1x10\^6 cells/kg at one or more occasions at weekly intervals.

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Patients with toxicity, inflammation or hemorrhages.

Exclusion Criteria

* None
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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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, Stockholm County, Sweden

Site Status RECRUITING

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

+46858582672

Other Identifiers

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DSCINF001

Identifier Type: -

Identifier Source: org_study_id

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