A Pilot Study Using Placenta Derived Decidual Stromal Cells for Toxicity and Inflammation With Special Focus to the Allogeneic Hematopoietic Cell Transplantation Setting
1 other identifier
interventional
25
1 country
1
Brief Summary
To evaluate safety and efficacy using decidual stromal cell therapy for toxicity and inflammation, with special focus on allogeneic hematopoietic cell transplantation patients. The hypothesis to be tested is that the cells are safe to infuse and that they have an anti-inflammatory and healing 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 Dec 2013
Longer than P75 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
Study Start
First participant enrolled
December 1, 2013
CompletedFirst Submitted
Initial submission to the registry
June 24, 2014
CompletedFirst Posted
Study publicly available on registry
June 26, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedJune 26, 2014
June 1, 2014
4 years
June 24, 2014
June 25, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Number of adverse events
Up to one year after inclusion
Secondary Outcomes (9)
Anti-inflammatory and reparatory effects regarding different lesions.
Up to one year after inclusion
Time to disappearance of hemorrhages.
Up to three months after inclusion
Time to disappearance of paresis and/or paresthesias.
Up to one year after inclusion
Time to disappearance of pain.
Up to one year after inclusion
Time to disappearance of pulmonary infiltrates
Up to one month after inclusion
- +4 more secondary outcomes
Study Arms (1)
Decidual stromal cell therapy for toxicity and inflammation
EXPERIMENTALPatients with toxicity, inflammation or hemorrhages will receive decidual stromal cells at approximately 1x10\^6 cells/kg at one or more occasions at weekly intervals dependent on clinical response.
Interventions
Decidual stromal cells from placenta will be infused intravenously at approximately 1x10\^6 cells/kg at one or more occasions at weekly intervals.
Eligibility Criteria
You may qualify if:
- Patients with toxicity, inflammation or hemorrhages.
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Karolinska Institutet
Stockholm, Stockholm County, 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 24, 2014
First Posted
June 26, 2014
Study Start
December 1, 2013
Primary Completion
December 1, 2017
Study Completion
December 1, 2017
Last Updated
June 26, 2014
Record last verified: 2014-06