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Decidual Stromal Cells as Treatment for Acute Graft Versus Host Disease, a Phase 1-2 Study

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: NCT02172937
Recruitment Status : Unknown
Verified November 2014 by Olle Ringdén, Karolinska Institutet.
Recruitment status was:  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 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: Decidual Stromal Cells thawed in plasma Biological: Decidual Stromal Cells thawed in human albumin Phase 1 Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Decidual Stromal Cells as Treatment for Acute Graft Versus Host Disease
Study Start Date : January 2011
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2016


Arm Intervention/treatment
Experimental: Decidual Stromal Cells as last line treatment
Patients with therapy-refractory GVHD and on calcineurin inhibitor and high dose corticosteroids without any signs of improvement will be given DSCs to evaluate a possible effect. DSCs will be thawed from the freezer in plasma.
Biological: Decidual Stromal Cells thawed in plasma
Active Comparator: Decidual Stromal Cells
Patients with therapy-refractory GVHD and on calcineurin inhibitor and high dose corticosteroids will be given DSCs as early as possible at one or more occasions at weekly intervals dependent on clinical response. DSCs will be thawed from the freezer in plasma.
Biological: Decidual Stromal Cells thawed in human albumin



Primary Outcome Measures :
  1. Actuarial survival at six months after first DSC infusion [ Time Frame: 6 months after inclusion ]

Secondary Outcome Measures :
  1. Response at 28 days after onset of graft versus host disease [ Time Frame: 28 days after inclusion ]

    Response will be measured as:

    • Partial response (PR) if the patient has improved one grade in the overall GvH.
    • Complete response (CR) if the patient is free of GvH.
    • Non responder (NR) if the patient does not improve after treatment.

  2. Response at 84 days after onset of graft versus host disease [ Time Frame: Up to 84 days after inclusion ]

    Response will be measured as:

    • Partial response (PR) if the patient has improved one grade in the overall GvH.
    • Complete response (CR) if the patient is free of GvH.
    • Non responder (NR) if the patient does not improve after treatment.

  3. Response at 168 days after onset of graft versus host disease [ Time Frame: Up to 168 days after inclusion ]

    Response will be measured as:

    • Partial response (PR) if the patient has improved one grade in the overall GvH.
    • Complete response (CR) if the patient is free of GvH.
    • Non responder (NR) if the patient does not improve after treatment.

  4. Side effects [ Time Frame: Up to 6 months after inclusion ]
    Adverse effects related to the treatment.

  5. Incidence of severe infections [ Time Frame: Up to one year after inclusion ]
    Severe bacterial, viral and fungal infections.

  6. Disease free survival [ Time Frame: Up to one year after inclusion ]
    Survival free from relapse.



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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.
  • Are on calcineurin inhibitor and high dose corticosteroids.

Exclusion Criteria:

None.


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): NCT02172937


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 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
Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Olle Ringdén, Professor, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT02172937    
Other Study ID Numbers: DSCGVHD002
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