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

June 25, 2014 updated by: Olle Ringdén, Karolinska Institutet
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

25

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Stockholm, Sweden, 14186
        • Recruiting
        • Karolinska Institutet
        • Contact:
        • Principal Investigator:
          • Olle Ringdén, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients with toxicity, inflammation or hemorrhages.

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Biological: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of adverse events
Time Frame: Up to one year after inclusion
Up to one year after inclusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of graft versus host disease
Time Frame: Up to one year after inclusion
Up to one year after inclusion
Anti-inflammatory and reparatory effects regarding different lesions.
Time Frame: Up to one year after inclusion
Clinical, neurophysiological and radiological evaluation of the lesions in question.
Up to one year after inclusion
Time to disappearance of hemorrhages.
Time Frame: Up to three months after inclusion
Up to three months after inclusion
Time to disappearance of paresis and/or paresthesias.
Time Frame: Up to one year after inclusion
Up to one year after inclusion
Time to disappearance of pain.
Time Frame: Up to one year after inclusion
Up to one year after inclusion
Time to disappearance of pulmonary infiltrates
Time Frame: Up to one month after inclusion
Disappearance of inflammatory processes in the lung.
Up to one month after inclusion
Time to disappearance of oxygen supplementation
Time Frame: Up to one month after inclusion
Up to one month after inclusion
Incidence of severe infections
Time Frame: Up to one year after inclusion
Incidence of severe bacterial, viral and fungal infections.
Up to one year after inclusion
Actuarial survival
Time Frame: Up to 5 years after inclusion
Up to 5 years after inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska Institutet

Investigators

  • Principal Investigator: Olle Ringdén, MD, PhD, Karolinska Institutet

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2013

Primary Completion (Anticipated)

December 1, 2017

Study Completion (Anticipated)

December 1, 2017

Study Registration Dates

First Submitted

June 24, 2014

First Submitted That Met QC Criteria

June 25, 2014

First Posted (Estimate)

June 26, 2014

Study Record Updates

Last Update Posted (Estimate)

June 26, 2014

Last Update Submitted That Met QC Criteria

June 25, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DSCINF001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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