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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
25
Decidual stromal cells from placenta will be infused intravenously at approximately 1x10\^6 cells/kg at one or more occasions at weekly intervals.
Karolinska Institutet
Stockholm, Stockholm County, Sweden
RECRUITINGNumber of adverse events
Time frame: Up to one year after inclusion
Anti-inflammatory and reparatory effects regarding different lesions.
Clinical, neurophysiological and radiological evaluation of the lesions in question.
Time frame: Up to one year after inclusion
Time to disappearance of hemorrhages.
Time frame: Up to three months after inclusion
Time to disappearance of paresis and/or paresthesias.
Time frame: Up to one year after inclusion
Time to disappearance of pain.
Time frame: Up to one year after inclusion
Time to disappearance of pulmonary infiltrates
Disappearance of inflammatory processes in the lung.
Time frame: Up to one month after inclusion
Time to disappearance of oxygen supplementation
Time frame: Up to one month after inclusion
Incidence of severe infections
Incidence of severe bacterial, viral and fungal infections.
Time frame: Up to one year after inclusion
Incidence of graft versus host disease
Time frame: Up to one year after inclusion
Actuarial survival
Time frame: Up to 5 years after inclusion
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