fibrotic interstitial lung disease
Conditions
Brief summary
1. Number and severity of adverse events in the treated group and the control / placebo group 2. Inhibition of the decline in FVC (reduction by less than 10% over the course of the study, reduction significantly less than in the placebo group) 3. Improving the quality of life 4. Annual survival
Detailed description
Evaluation of: - changes in FVC - quality of life of patients - number of exacerbations during the annual total - survival during annual follow-up - pharmacokinetics and pharmacodynamics of the MSC preparation after administration
Interventions
DRUGsolution 10% dimethylsulfoxide in 5% human albumin
DRUGallogeneic mesenchymal stem cells derived from Wharton's jelly
Sponsors
Medical University Of Gdansk
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Number and severity of adverse events in the treated group and the control / placebo group 2. Inhibition of the decline in FVC (reduction by less than 10% over the course of the study, reduction significantly less than in the placebo group) 3. Improving the quality of life 4. Annual survival | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluation of: - changes in FVC - quality of life of patients - number of exacerbations during the annual total - survival during annual follow-up - pharmacokinetics and pharmacodynamics of the MSC preparation after administration | — |
Countries
Poland
Outcome results
None listed