Safety of Endobronchial Mesenchymal Stromal Cells in the Treatment of Chronic Lung Allograft Dysfunction

NCT ID: NCT06514378

Last Updated: 2024-07-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-19
• Study Completion Date: 2026-03-31

Brief Summary

Lung transplantation is the only therapeutic alternative for more and more patients with respiratory diseases in their most advanced stages.

The most limiting factor to achieve long term survival si chronic lung allograft dysfunction, a multifactorial disease without an effective treatment.

The immunomodulatory capacity of mesenchymal stem cells enables them to be a potential therapeutic agent for this condition.

The objective of this study is to assess the safety of endobronchial administration of allogeneic MSCs in patients with chroniclung allograft dysfunction.

Conditions

Chronic Lung Disease; Lung Transplant Rejection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment group

Group Type: EXPERIMENTAL

Mesenchymal stem cells

Intervention Type: BIOLOGICAL

Endobronchial administration of 10⁶ MSCs/kg in each transplanted lung, 4 weeks apart.

Control

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Mesenchymal stem cells

Endobronchial administration of 10⁶ MSCs/kg in each transplanted lung, 4 weeks apart.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

Patients should have signed written informed consent. Adult patients ≥18 years of age at the time of enrolment Patients recipients of a uni or bipulmonary transplant An established diagnosis of BOS ≧ 0p (FEV1≤90% and / or FEF 25-75% ≤ of the baseline value with no other justifying cause) in the last 6 months.

Exclusion Criteria

• History of lobar transplantation History of heart-lung transplantation Active infection at the time of inclusion. Active Acute Rejection not treated at the time of inclusion. Oncological history (except cutaneous basal cell or carcinoma in situ) Systemic autoimmune diseases. Active HIV / HBV / HCV infection (confirmed by serology or PCR) Proximal airway stenosis Pregnancy Performance status 3 or 4 (confined to bed or chair for more than 50% of waking hours, able only to perform some self-care activities) Estimated survival less than 3 months. Known hypersensitivity to components used in the production of allogeneic MSCs. Any circumstance that, in the opinion of the investigator, compromises the patient's ability to participate in the clinical trial.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ministerio de Ciencia, Innovación y Universidades

UNKNOWN

Sponsor Role: collaborator

Instituto De Investigación Sanitaria Puerta De Hierro-Segovia De Arana

OTHER

Sponsor Role: lead

Responsible Party

David Gomez de Antonio

Head of Research Group

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hospital Universitario Puerta de Hierro Majadahonda

Madrid, , Spain

Site Status: RECRUITING

Countries

Spain

Facility Contacts

David Gomez de Antonio, PhD

Role: primary

dgavm@yahoo.es

+341916623

Other Identifiers

ICI/00122

Identifier Type: -

Identifier Source: org_study_id