fibrotic interstitial lung disease
Conditions
Interventions
Product Name: allogeneic mesenchymal stem cells derived from Wharton’s jelly
Product Code: Allogeneic WJ-MSC
Pharmaceutical Form: Suspension for injection
Pharmaceutical form of the placebo: Solution
Sponsors
Medical University of Gdansk
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Group I, patients diagnosed with IPF: 1. Patients over 18 years of age 2. Diagnosis of some common interstitial pneumonia (UIP) based on chest CT scan/lung parenchyma biopsy 3. FVC > 40% nv 4. DLCO > 25% nv 5. Informed written consent to participate in the study Group II, patients diagnosed with restrictive fibrosis after COVID-19: 1. Patients over 18 years of age 2. History of diagnosis of severe pneumonia in the course of COVID-19 3. Negative test for SARS-COV2 on the day of inclusion in the study 4. Diagnosis of fibrotic changes in the lungs 5. Informed written consent to participate in the study Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 25 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: 1. Inability to give informed consent in writing 2. Current or history of cancer. 3. Lower respiratory tract infection within 4 weeks before entering the study. 4. Clinically confirmed active infection that, in the investigator's judgment, may interfere with the examination, pulmonary function measurements, or may influence the course of pulmonary disease 5. Previous or active form of infection with HBV, HCV, HIV, suspected infection with M. tuberculosis, spirochete syphilis 6. Participation in a study of an experimental medicinal product within 4 weeks before entering the study (not less than 5 half-lives of the study product). 7. Significant coexisting diseases of other organs, including: liver or organ failure, including liver failure or kidneys 8. History of liver failure, elevated transaminase enzymes or exceeding the limits of any of the following criteria in liver function tests: o Total bilirubin 3x above the upper limit of normal o o Aspartate aminotransferase (AST) or aminotransferase alanine acid (ALT) >3× upper limit of normal o Alkaline phosphatase > 3× upper limit of normal. 9. Creatinine clearance <30 ml/min, calculated based on the Cockcroft-Gault.Gault formula. Ccreat[ml/min]=(140-age) x body weight (kg) / (Ccreate x 72) x W 10. Use of tobacco products in the 12 weeks before the start of the phase screening or failure to agree to stop using tobacco products until the last visit in the follow-up period. 11. Women who are pregnant or breastfeeding or planning to become pregnant during the study. 12. Women - positive pregnancy test or not using a medically recognized form of contraception during the test (hormonal, barrier) and up to 4 months after its completion, if applicable. 13. Men - expressed intention to have children during the study and up to 4 months after its completion, if applicable. 14. Excessive anxiety of the patient regarding the procedures used in the examination. 15. Any medical problem that, in the opinion of the investigator, may adversely affect health patient if included in the study 16. Diagnosed addiction to alcohol or psychoactive substances 17. Major surgery scheduled during the study period. 18. Simultaneous participation in a drug program for other indications 19. History of allergy to penicillin, streptomycin or amphotericin B.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluation of usage and safety of allogenic Mesenchymas cells of Wharton Jelly as a possible method of treatment of fibrotic interstitial lung disease especially diopathic pulmonry fibrosis and pulmonary fibrosis after COVID-19;Secondary Objective: 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;Primary end point(s): 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 ;Timepoint(s) of evaluation of this end point: 1. Day of first administration of MSC / antifibrotics / placebo - day "0" 2. 14 days from first MSC administration / study start 3. Day of the second MSC administration / continuation of antifibrotic drugs / placebo - day "+30" 4. 14 days from second MSC administration / 44 days from start of study 5. Day of the third MSC administration / continuation of antifibrotic drugs / placebo is day "+60" 6. 14 days after last dose of MSC / 74 days from start of study 7. 90 ± 14 days after last dose of MSC / 90 ± 14 days from study start 8. 180 ± 14 days after last dose of MSC / 180 ± 14 days from study start 9. 360 ± 14 days after the last dose of MSC / 360 ± 14 days from the start of the study | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): None;Timepoint(s) of evaluation of this end point: None | — |
Countries
Poland
Contacts
Public ContactBeata Wajda
The University Clinical Centre
Outcome results
None listed