ALLOGENEIC WHARTON'S JELLY-DERIVED MESENCHYMAL STEM CELLS for Fibrotic interstitial lung disease | Idiopathic pulmonary fibrosis | Post-COVID-19 pulmonary fibrosis

Inclusion criteria

• {"criterion_text":"- Group I, patients diagnosed with IPF: 1. Patients over 18 years of age\n- Group I, patients diagnosed with IPF: 2. Diagnosis of some usual interstitial pneumonia (UIP) based on thoracic WRTK / lung parenchyma biopsy in IPF idiopathic pulmonary fibrosis\n- Group I, patients diagnosed with IPF: 3. FVC> 40% nw\n- Group I, patients diagnosed with IPF: 4. DLCO> 25% nw\n- Group I, patients diagnosed with IPF: 5. FVC progression greater than 10% during the year excluding from the drug program\n- Group I, patients diagnosed with IPF: 6. Informed consent form (ICF) to participate in the study\n- Group II, patients diagnosed with restrictive fibrosis after COVID-19: 1. Patients over 18 years of age\n- Group II, patients diagnosed with restrictive fibrosis after COVID-19: 2. History of severe COVID-19 pneumonia\n- Group II, patients diagnosed with restrictive fibrosis after COVID-19: 3. Negative SARS-COV2 antigenic test , at least 4 weeks prior to study inclusion\n- Group II, patients diagnosed with restrictive fibrosis after COVID-19: 4. Diagnosis of interstitial lung fibrosis\n- Group II, patients diagnosed with restrictive fibrosis after COVID-19: 5. Informed consent form (ICF) to participate in the study"}

Exclusion criteria

• {"criterion_text":"- 1. Inability to provide informed consent form (ICF)\n- 2. Current or history of cancer.\n- 3. Lower respiratory tract infection within 4 weeks prior to study enrollment.\n- 4. Clinically proven active infection that in the investigator's opinion, may interfere with the course of the study, perform lung function measurements, or may affect the course of lung disease\n- 5. Previous or active form of infection with HBV, HCV, HIV, mycobacterium tuberculosis, syphilis spirochete. Laboratory indicators of infection are sufficient for diagnosis without the need to identify clinical symptoms.\n- 6. Participation in the study of an experimental medicinal product within 4 weeks prior to enrollment in the study (not less than 5 half-lives of the investigated product).\n- 7. Significant coexisting diseases of other organs, including liver or kidney failure\n- 8. History of liver failure, elevated levels of transaminase enzymes or exceeding the breakpoints of any of the following criteria in liver function tests: Total bilirubin above the upper limit of normal, Aspartic aminotransferase (AST) or alanine aminotransferase (ALT)> 2 × upper limit of normal, Alkaline phosphatase> 2.0 × ULN.\n- 9. Creatinine clearance <30 ml / min by the Cockcroft-Gault formula.\n- 10. Use of tobacco products within the 12 weeks prior to the start of the screening phase, or refusal to agree to stop using tobacco products until the last follow-up visit.\n- 11. Pregnant women and breastfeeding or planning to become pregnant during the examination\n- 12. Women - positive pregnancy test or no use of a medically recognized anti-conception during the study and up to 4 months after its completion, if applicable.\n- 13. Men - expressed intention to have children during the study and up to 4 months after its completion, if applicable.\n- 14. Excessive anxiety of the patient with regard to the procedures used in the study.\n- 15. Any medical problem that in the opinion of the investigator, may adversely affect the patient's health, if included in the study\n- 16. Diagnosed addiction to alcohol or psychoactive substances\n- 17. Surgery scheduled during the study period.\n- 18. Participation in the drug program\n- 19. History of allergy to penicillin, streptomycin or amphotericin B"}

Primary endpoints

• {"endpoint_text":"- 1. Number and severity of adverse events in the treated group and the control / placebo group","definition_or_measurement_approach":"Number and severity of adverse events collected and compared between treated and control/placebo groups (as stated in endpoint)."}
• {"endpoint_text":"- 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)","definition_or_measurement_approach":"Forced Vital Capacity (FVC) decline measured over study duration; endpoint defined as reduction by less than 10% over course of study and significantly less than in placebo group."}
• {"endpoint_text":"- 3. Improving the quality of life","definition_or_measurement_approach":""}
• {"endpoint_text":"- 4. Annual survival","definition_or_measurement_approach":"Survival status assessed at annual follow-up (one-year survival)."}

Secondary endpoints

• {"endpoint_text":"- Evaluation of: - changes in FVC","definition_or_measurement_approach":""}
• {"endpoint_text":"- Evaluation of: - quality of life of patients","definition_or_measurement_approach":""}
• {"endpoint_text":"- Evaluation of: - number of exacerbations during the annual total","definition_or_measurement_approach":""}
• {"endpoint_text":"- Evaluation of: - survival during annual follow-up","definition_or_measurement_approach":""}
• {"endpoint_text":"- Evaluation of: - pharmacokinetics and pharmacodynamics of the MSC preparation after administration","definition_or_measurement_approach":""}

Poland

Earliest CTIS Part Ii Submission Date

26-09-2024

Latest Decision Or Authorization Date

13-05-2025

Processing Time Days

229

Number Of Sites

1

Number Of Participants

45

Primary sponsor

Full Name

Medical University Of Gdansk

Organisation Type

Educational Institution

Country Of Registered Address

Poland