A Phase 2 Study Using Placenta Derived Decidual Stromal Cells for Graft Versus Host Disease
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1
Started Jan 2017
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 17, 2014
CompletedFirst Posted
Study publicly available on registry
June 24, 2014
CompletedStudy Start
First participant enrolled
January 1, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedNovember 11, 2014
November 1, 2014
2.9 years
June 17, 2014
November 8, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Actuarial survival at one year after onset of graft versus host disease
12 months after inclusion
Secondary Outcomes (4)
Response at 28 days after onset of graft versus host disease
28 days after inclusion
Side effects
Up to 6 months after inclusion
Incidence of severe infections
Up to 12 months after inclusion
Disease free survival
12 months after inclusion
Study Arms (2)
Early Decidual Stromal Cells
ACTIVE COMPARATORPatients 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.
Late Decidual Stromal Cells
ACTIVE COMPARATORPatients with therapy-refractory GVHD and on calcineurin inhibitor and high dose corticosteroids for longer than 7 days will be given Decidual Stromal Cell therapy.
Interventions
Intervention given within 7 days after corticosteroids.
Intervention given after 7 days after corticosteroids.
Eligibility Criteria
You may qualify if:
- Acute graft versus host disease grade 2-4 or therapy resistant chronic graft versus host disease.
- Are on calcineurin inhibitor and high dose corticosteroids.
You may not qualify if:
- Terminally ill patients
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Karolinska Institutetlead
- Karolinska University Hospitalcollaborator
Study Sites (1)
Karolinska Institutet
Stockholm, 14186, Sweden
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Olle Ringdén, MD, PhD
Karolinska Institutet
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
June 17, 2014
First Posted
June 24, 2014
Study Start
January 1, 2017
Primary Completion
December 1, 2019
Study Completion
December 1, 2019
Last Updated
November 11, 2014
Record last verified: 2014-11