The study evaluates the safety and the efficacy of the addition of intravenous transplantation of donor bone marrow mesenchymal stem cells in patients with idiopathic interstitial pneumonia or connective tissue disease associated with interstitial lung disease, which have actively progressing disease with rapid loss of pulmonary function on the background of routine treatment.
Despite significant progress in the treatment of interstitial lung disease, achieved thanks to new drugs, such as pirfenidone and nintedanib, there are many patients for whom these drugs are not available or poorly tolerated. In addition significant evidence of their effectiveness and safety is valid only for idiopathic pulmonary fibrosis. The transplantation of allogeneic stem cells is a promising direction in the modern medicine with the proven safety for different diseases. But the effectiveness of this therapy is still under research. We believe that in most severe cases of a rapidly progressive interstitial lung disease the transplantation of mesenchymal stem cells may be an effective technology due to their immunomodulatory properties.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Bone marrow will be harvested in healthy donors followed by separation and cultivation of MSCs. Before infusion cells will be suspended in 400 mL saline
intravenous infusion of 400 mL saline
Federal Research Clinical Center FMBA of Russia
Moscow, Russia
Safety: Number of serious adverse events
registration of adverse events related to infusion and 12 months follow-up
Time frame: 12 months
DLCO changes from baseline
Assessment of the diffusing lung capacity at 3, 6, 9, 12 months of treatment
Time frame: 12 months
FVC changes from baseline
Assessment of spirometry at 3, 6, 9, 12 months of treatment
Time frame: 12 months
exercise capacity changes
Assessment of 6MWD at 3, 6, 9, 12 months of treatment
Time frame: 12 months
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