Back to resultsA Phase 2 Study Using Placenta Derived Decidual Stromal Cells for Graft Versus Host Disease
Primary Purpose
Graft vs Host Disease
Status
Unknown status
Phase
Phase 1
Locations
Sweden
Study Type
Interventional
Intervention
Early Decidual stromal cell therapy
Late Decidual stromal cell therapy
Sponsored by
About this trial
This is an interventional treatment trial for Graft vs Host Disease focused on measuring Stem Cell Transplantation, Decidual Stromal Cells
Eligibility 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
Sites / Locations
- Karolinska Institutet
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Early Decidual Stromal Cells
Late Decidual Stromal Cells
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Actuarial survival at one year after onset of graft versus host disease
Secondary Outcome Measures
Response at 28 days after onset of graft versus host disease
Side effects
Incidence of severe infections
Disease free survival
Full Information
NCT ID
NCT02172924
First Posted
June 17, 2014
Last Updated
November 8, 2014
Sponsor
Karolinska Institutet
Collaborators
Karolinska University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02172924
Brief Title
A Phase 2 Study Using Placenta Derived Decidual Stromal Cells for Graft Versus Host Disease
Official Title
A Phase 2 Study Using Placenta Derived Decidual Stromal Cells for Graft Versus Host Disease
Study Type
Interventional
2. Study Status
Record Verification Date
November 2014
Overall Recruitment Status
Unknown status
Study Start Date
January 2017 (undefined)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Karolinska Institutet
Collaborators
Karolinska University Hospital
4. Oversight
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Graft vs Host Disease
Keywords
Stem Cell Transplantation, Decidual Stromal Cells
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Early Decidual Stromal Cells
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Late Decidual Stromal Cells
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Early Decidual stromal cell therapy
Intervention Description
Intervention given within 7 days after corticosteroids.
Intervention Type
Biological
Intervention Name(s)
Late Decidual stromal cell therapy
Intervention Description
Intervention given after 7 days after corticosteroids.
Primary Outcome Measure Information:
Title
Actuarial survival at one year after onset of graft versus host disease
Time Frame
12 months after inclusion
Secondary Outcome Measure Information:
Title
Response at 28 days after onset of graft versus host disease
Time Frame
28 days after inclusion
Title
Side effects
Time Frame
Up to 6 months after inclusion
Title
Incidence of severe infections
Time Frame
Up to 12 months after inclusion
Title
Disease free survival
Time Frame
12 months after inclusion
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Olle Ringdén, MD, PhD
Phone
+46858582672
Email
olle.ringden@ki.se
First Name & Middle Initial & Last Name or Official Title & Degree
Helen Kaipe, PhD
Phone
+46700901052
Email
helen.kaipe@ki.se
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olle Ringdén, MD, PhD
Organizational Affiliation
Karolinska Institutet
Official's Role
Principal Investigator
Facility Information:
Facility Name
Karolinska Institutet
City
Stockholm
ZIP/Postal Code
14186
Country
Sweden
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olle Ringdén, MD, PhD
Phone
+858582672
Email
olle.ringden@ki.se
First Name & Middle Initial & Last Name & Degree
Olle Ringdén, MD, PhD
12. IPD Sharing Statement
Learn more about this trial
A Phase 2 Study Using Placenta Derived Decidual Stromal Cells for Graft Versus Host Disease
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