Acute Lung Injury, Decidual Stromal Cells, Inflammation, Stem Cell Transplantation
Conditions
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.
Detailed description
Patients 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
BIOLOGICALDecidual stromal cell therapy
Decidual stromal cells from placenta will be infused intravenously at approximately 1x10\^6 cells/kg at one or more occasions at weekly intervals.
Sponsors
Karolinska Institutet
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Patients with toxicity, inflammation or hemorrhages.
Exclusion criteria
* None
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of adverse events | Up to one year after inclusion |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | Disappearance of inflammatory processes in the lung. |
| Anti-inflammatory and reparatory effects regarding different lesions. | Up to one year after inclusion | Clinical, neurophysiological and radiological evaluation of the lesions in question. |
| Incidence of severe infections | Up to one year after inclusion | Incidence of severe bacterial, viral and fungal infections. |
| Incidence of graft versus host disease | Up to one year after inclusion | — |
| Actuarial survival | Up to 5 years after inclusion | — |
| Time to disappearance of oxygen supplementation | Up to one month after inclusion | — |
Countries
Sweden
Contacts
Primary ContactOlle Ringdén, MD, PhD
Backup ContactHelen Kaipe, PhD
Outcome results
None listed