Back to resultsDecidual Stromal Cells as Treatment for Acute Graft Versus Host Disease, a Phase 1-2 Study
Primary Purpose
Graft vs Host Disease
Status
Unknown status
Phase
Phase 1
Locations
Sweden
Study Type
Interventional
Intervention
Decidual Stromal Cells thawed in plasma
Decidual Stromal Cells thawed in human albumin
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.
- Are on calcineurin inhibitor and high dose corticosteroids.
Exclusion Criteria:
None.
Sites / Locations
- Karolinska InstitutetRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Decidual Stromal Cells as last line treatment
Decidual Stromal Cells
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Actuarial survival at six months after first DSC infusion
Secondary Outcome Measures
Response at 28 days after onset of graft versus host disease
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.
Response at 84 days after onset of graft versus host disease
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.
Response at 168 days after onset of graft versus host disease
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.
Side effects
Adverse effects related to the treatment.
Incidence of severe infections
Severe bacterial, viral and fungal infections.
Disease free survival
Survival free from relapse.
Full Information
NCT ID
NCT02172937
First Posted
June 17, 2014
Last Updated
November 8, 2014
Sponsor
Karolinska Institutet
Collaborators
Karolinska University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02172937
Brief Title
Decidual Stromal Cells as Treatment for Acute Graft Versus Host Disease, a Phase 1-2 Study
Official Title
Decidual Stromal Cells as Treatment for Acute Graft Versus Host Disease
Study Type
Interventional
2. Study Status
Record Verification Date
November 2014
Overall Recruitment Status
Unknown status
Study Start Date
January 2011 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
December 2016 (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 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 1-2x10^6 cells/kg at one or more occasions 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
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Decidual Stromal Cells as last line treatment
Arm Type
Experimental
Arm Description
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.
Arm Title
Decidual Stromal Cells
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Decidual Stromal Cells thawed in plasma
Intervention Type
Biological
Intervention Name(s)
Decidual Stromal Cells thawed in human albumin
Primary Outcome Measure Information:
Title
Actuarial survival at six months after first DSC infusion
Time Frame
6 months after inclusion
Secondary Outcome Measure Information:
Title
Response at 28 days after onset of graft versus host disease
Description
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.
Time Frame
28 days after inclusion
Title
Response at 84 days after onset of graft versus host disease
Description
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.
Time Frame
Up to 84 days after inclusion
Title
Response at 168 days after onset of graft versus host disease
Description
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.
Time Frame
Up to 168 days after inclusion
Title
Side effects
Description
Adverse effects related to the treatment.
Time Frame
Up to 6 months after inclusion
Title
Incidence of severe infections
Description
Severe bacterial, viral and fungal infections.
Time Frame
Up to one year after inclusion
Title
Disease free survival
Description
Survival free from relapse.
Time Frame
Up to one year after inclusion
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Acute graft versus host disease grade 2-4.
Are on calcineurin inhibitor and high dose corticosteroids.
Exclusion Criteria:
None.
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
Individual Site Status
Recruiting
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
Citations:
PubMed Identifier
23701127
Citation
Erkers T, Nava S, Yosef J, Ringden O, Kaipe H. Decidual stromal cells promote regulatory T cells and suppress alloreactivity in a cell contact-dependent manner. Stem Cells Dev. 2013 Oct 1;22(19):2596-605. doi: 10.1089/scd.2013.0079. Epub 2013 Jul 2.
Results Reference
background
PubMed Identifier
23307526
Citation
Ringden O, Erkers T, Nava S, Uzunel M, Iwarsson E, Conrad R, Westgren M, Mattsson J, Kaipe H. Fetal membrane cells for treatment of steroid-refractory acute graft-versus-host disease. Stem Cells. 2013 Mar;31(3):592-601. doi: 10.1002/stem.1314.
Results Reference
result
PubMed Identifier
31173898
Citation
Sadeghi B, Remberger M, Gustafsson B, Winiarski J, Moretti G, Khoein B, Klingspor L, Westgren M, Mattsson J, Ringden O. Long-Term Follow-Up of a Pilot Study Using Placenta-Derived Decidua Stromal Cells for Severe Acute Graft-versus-Host Disease. Biol Blood Marrow Transplant. 2019 Oct;25(10):1965-1969. doi: 10.1016/j.bbmt.2019.05.034. Epub 2019 Jun 4.
Results Reference
derived
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Decidual Stromal Cells as Treatment for Acute Graft Versus Host Disease, a Phase 1-2 Study
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