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Assessment of the effect of Wharton's jelly mesenchymal stem cell preparation (WJMSCs) in the treatment of fibrotic interstitial lung diseases
EU CTIS ID: 2024-514433-38-00
What this study is testing
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
- Phase I and Phase II (Integrated)- Other
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Group I, patients diagnosed with IPF: 1. Patients over 18 years of age 2. Diagnosis of some usual interstitial pneumonia (UIP) based on thoracic WRTK / lung parenchyma biopsy in IPF idiopathic pulmonary fibrosis 3. FVC> 40% nw 4. DLCO> 25% nw 5. FVC progression greater than 10% during the year excluding from the drug program 6. Informed consent form (ICF) 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 severe COVID-19 pneumonia 3. Negative SARS-COV2 antigenic test , at least 4 weeks prior to study inclusion 4. Diagnosis of interstitial lung fibrosis 5. Informed consent form (ICF) to participate in the study
You likely can't join if
- 1. Inability to provide informed consent form (ICF) 2. Current or history of cancer. 3. Lower respiratory tract infection within 4 weeks prior to study enrollment. 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 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. 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). 7. Significant coexisting diseases of other organs, including liver or kidney failure 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. 9. Creatinine clearance <30 ml / min by the Cockcroft-Gault formula. 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. 11. Pregnant women and breastfeeding or planning to become pregnant during the examination 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. 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 with regard to the procedures used in the study. 15. Any medical problem that in the opinion of the investigator, may adversely affect the patient's health, if included in the study 16. Diagnosed addiction to alcohol or psychoactive substances 17. Surgery scheduled during the study period. 18. Participation in the drug program 19. History of allergy to penicillin, streptomycin or amphotericin B
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.