A Pilot Study Using Placenta Derived Decidual Stromal Cells for Toxicity and Inflammation With Special Focus to the Allogeneic Hematopoietic Cell Transplantation Setting

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Conditions
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Acute Lung Injury, Decidual Stromal Cells, Stem Cell Transplantation, Inflammation

Intervention / Treatment
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* Biological: Decidual stromal cell therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with toxicity, inflammation or hemorrhages. Exclusion Criteria: None
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Decidual stromal cell therapy for toxicity and inflammation<br>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. | Biological: Decidual stromal cell therapy<br>* Decidual stromal cells from placenta will be infused intravenously at approximately 1x10^6 cells/kg at one or more occasions at weekly intervals.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of adverse events |  | Up to one year after inclusion | 

Secondary Outcome Measures

| Outcome Measure | 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. |  | 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 |