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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02172924
Recruitment Status : Unknown
Verified November 2014 by Olle Ringdén, Karolinska Institutet.
Recruitment status was:  Not yet recruiting
First Posted : June 24, 2014
Last Update Posted : November 11, 2014
Sponsor:
Collaborator:
Karolinska University Hospital
Information provided by (Responsible Party):
Olle Ringdén, Karolinska Institutet

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Graft vs Host Disease Biological: Early Decidual stromal cell therapy Biological: Late Decidual stromal cell therapy Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Study Using Placenta Derived Decidual Stromal Cells for Graft Versus Host Disease
Study Start Date : January 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Actuarial survival at one year after onset of graft versus host disease [ Time Frame: 12 months after inclusion ]

Secondary Outcome Measures :
  1. Response at 28 days after onset of graft versus host disease [ Time Frame: 28 days after inclusion ]
  2. Side effects [ Time Frame: Up to 6 months after inclusion ]
  3. Incidence of severe infections [ Time Frame: Up to 12 months after inclusion ]
  4. Disease free survival [ Time Frame: 12 months after inclusion ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02172924


Contacts
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Contact: Olle Ringdén, MD, PhD +46858582672 olle.ringden@ki.se
Contact: Helen Kaipe, PhD +46700901052 helen.kaipe@ki.se

Locations
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Sweden
Karolinska Institutet Not yet recruiting
Stockholm, Sweden, 14186
Contact: Olle Ringdén, MD, PhD    +858582672    olle.ringden@ki.se   
Principal Investigator: Olle Ringdén, MD, PhD         
Sponsors and Collaborators
Karolinska Institutet
Karolinska University Hospital
Investigators
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Principal Investigator: Olle Ringdén, MD, PhD Karolinska Institutet

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Responsible Party: Olle Ringdén, Professor, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT02172924     History of Changes
Other Study ID Numbers: DSCGVHD001
First Posted: June 24, 2014    Key Record Dates
Last Update Posted: November 11, 2014
Last Verified: November 2014
Keywords provided by Olle Ringdén, Karolinska Institutet:
Stem Cell Transplantation
Decidual Stromal Cells
Additional relevant MeSH terms:
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Graft vs Host Disease
Immune System Diseases