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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT02175303 |
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Date of registration:
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24/06/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A Pilot Study Using Placenta Derived Decidual Stromal Cells for Toxicity and Inflammation With Special Focus to the Allogeneic Hematopoietic Cell Transplantation Setting
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Scientific title:
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Date of first enrolment:
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December 2013 |
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Target sample size:
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25 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT02175303 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 1/Phase 2
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Countries of recruitment
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Sweden
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Contacts
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Name:
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Olle Ringdén, MD, PhD |
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Address:
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Telephone:
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+46858582672 |
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Email:
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olle.ringden@ki.se |
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Affiliation:
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Name:
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Olle Ringdén, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Karolinska Institutet |
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Name:
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Olle Ringdén, MD, PhD |
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Address:
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Telephone:
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+46858582672 |
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Email:
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olle.ringden@ki.se |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients with toxicity, inflammation or hemorrhages.
Exclusion Criteria:
- None
Age minimum:
N/A
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Decidual Stromal Cells
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Inflammation
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Stem Cell Transplantation
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Acute Lung Injury
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Intervention(s)
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Biological: Decidual stromal cell therapy
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Primary Outcome(s)
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Number of adverse events
[Time Frame: Up to one year after inclusion]
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Secondary Outcome(s)
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Incidence of severe infections
[Time Frame: Up to one year after inclusion]
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Time to disappearance of pulmonary infiltrates
[Time Frame: Up to one month after inclusion]
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Anti-inflammatory and reparatory effects regarding different lesions.
[Time Frame: Up to one year after inclusion]
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Time to disappearance of oxygen supplementation
[Time Frame: Up to one month after inclusion]
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Time to disappearance of pain.
[Time Frame: Up to one year after inclusion]
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Time to disappearance of paresis and/or paresthesias.
[Time Frame: Up to one year after inclusion]
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Time to disappearance of hemorrhages.
[Time Frame: Up to three months after inclusion]
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Actuarial survival
[Time Frame: Up to 5 years after inclusion]
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Incidence of graft versus host disease
[Time Frame: Up to one year after inclusion]
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Secondary ID(s)
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DSCINF001
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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