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

November 8, 2014 updated by: Olle Ringdén, Karolinska Institutet
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

30

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
        • Karolinska Institutet

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:

  • 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

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
Active Comparator: 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.
Biological: Early Decidual stromal cell therapy
Intervention given within 7 days after corticosteroids.
Active Comparator: 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.
Biological: Late Decidual stromal cell therapy
Intervention given after 7 days after corticosteroids.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Actuarial survival at one year after onset of graft versus host disease
Time Frame: 12 months after inclusion
12 months after inclusion

Secondary Outcome Measures

Outcome Measure
Time Frame
Response at 28 days after onset of graft versus host disease
Time Frame: 28 days after inclusion
28 days after inclusion
Side effects
Time Frame: Up to 6 months after inclusion
Up to 6 months after inclusion
Incidence of severe infections
Time Frame: Up to 12 months after inclusion
Up to 12 months after inclusion
Disease free survival
Time Frame: 12 months after inclusion
12 months after inclusion

Collaborators and Investigators

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

Sponsor

Karolinska Institutet

Collaborators

Karolinska University Hospital

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

January 1, 2017

Primary Completion (Anticipated)

December 1, 2019

Study Completion (Anticipated)

December 1, 2019

Study Registration Dates

First Submitted

June 17, 2014

First Submitted That Met QC Criteria

June 23, 2014

First Posted (Estimate)

June 24, 2014

Study Record Updates

Last Update Posted (Estimate)

November 11, 2014

Last Update Submitted That Met QC Criteria

November 8, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DSCGVHD001

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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