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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Decidual stromal cell therapy for toxicity and inflammation | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Decidual stromal cell therapy | Biological | Decidual stromal cells from placenta will be infused intravenously at approximately 1x10^6 cells/kg at one or more occasions at weekly intervals. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of adverse events | Up to one year after inclusion |
| Measure | Description | Time Frame |
|---|---|---|
| Anti-inflammatory and reparatory effects regarding different lesions. | Clinical, neurophysiological and radiological evaluation of the lesions in question. | Up to one year after inclusion |
| Time to disappearance of hemorrhages. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Olle Ringdén, MD, PhD | Contact | +46858582672 | olle.ringden@ki.se | |
| Helen Kaipe, PhD | Contact | +46700901052 | helen.kaipe@ki.se |
| Name | Affiliation | Role |
|---|---|---|
| Olle Ringdén, MD, PhD | Karolinska Institutet | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karolinska Institutet | Recruiting | Stockholm | Stockholm County | 14186 | Sweden |
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| 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 | Disappearance of inflammatory processes in the lung. | Up to one month after inclusion |
| Time to disappearance of oxygen supplementation | Up to one month after inclusion |
| Incidence of severe infections | Incidence of severe bacterial, viral and fungal infections. | Up to one year after inclusion |
| Incidence of graft versus host disease | Up to one year after inclusion |
| Actuarial survival | Up to 5 years after inclusion |
| ID | Term |
|---|---|
| D055371 | Acute Lung Injury |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D055370 | Lung Injury |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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