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Outcome Measures

Primary Outcomes (1)

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 Outcomes (1)

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

Registry intervention entries

These entries preserve how the registry describes the intervention. Their treatment roles are shown separately from molecular identities.

Formulated product

Ofev 100 mg soft capsules

The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.

CAPSULE, SOFT

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Formulated product

Esbriet 267 mg film-coated tablets

The registry describes a specific formulation. Its exact chemical ingredients and approval status require separate evidence.

FILM-COATED TABLET

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Eligibility Criteria

Sexall

Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

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

Source record

Download the complete CTIS (EMA) record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.

Source: European Medicines Agency (EMA), Clinical Trials Information System (CTIS). Original record and public documents are available on CTIS.

JSON downloads include source attribution and retrieval details alongside the unchanged original record or the separately normalized values.

Registry identifier

2024-514433-38-00

Data provider

European Medicines Agency (EMA)

Normalization version

ctis-v1

Source retrieved: 2026-10-30 05:11:29 UTC

Assessment of the effect of Wharton's jelly mesenchymal stem cell preparation (WJMSCs) in the treatment of fibrotic interstitial lung diseases

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Interventions

Registry intervention entries

Ingredients named in source formulations

Eligibility Criteria

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Central Study Contacts

Study Design

Study Record Dates

Source record

Documents

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Interventions

Registry intervention entries

Ingredients named in source formulations

Eligibility Criteria

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Central Study Contacts

Study Design

Study Record Dates

Source record

Documents

Locations