Inflammation Clinical Trial
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.
Status | Recruiting |
Enrollment | 25 |
Est. completion date | December 2017 |
Est. primary completion date | December 2017 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | N/A and older |
Eligibility |
Inclusion Criteria: - Patients with toxicity, inflammation or hemorrhages. Exclusion Criteria: |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Sweden | Karolinska Institutet | Stockholm |
Lead Sponsor | Collaborator |
---|---|
Karolinska Institutet |
Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of adverse events | Up to one year after inclusion | Yes | |
Secondary | Anti-inflammatory and reparatory effects regarding different lesions. | Clinical, neurophysiological and radiological evaluation of the lesions in question. | Up to one year after inclusion | No |
Secondary | Time to disappearance of hemorrhages. | Up to three months after inclusion | No | |
Secondary | Time to disappearance of paresis and/or paresthesias. | Up to one year after inclusion | No | |
Secondary | Time to disappearance of pain. | Up to one year after inclusion | No | |
Secondary | Time to disappearance of pulmonary infiltrates | Disappearance of inflammatory processes in the lung. | Up to one month after inclusion | No |
Secondary | Time to disappearance of oxygen supplementation | Up to one month after inclusion | No | |
Secondary | Incidence of severe infections | Incidence of severe bacterial, viral and fungal infections. | Up to one year after inclusion | Yes |
Secondary | Incidence of graft versus host disease | Up to one year after inclusion | Yes | |
Secondary | Actuarial survival | Up to 5 years after inclusion | No |
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