Actively Recruiting

Phase 1
Age: 18Years +
All Genders
NCT06514378

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

Led by Instituto De Investigación Sanitaria Puerta De Hierro-Segovia De Arana · Updated on 2024-07-26

12

Participants Needed

1

Research Sites

132 weeks

Total Duration

On this page

Sponsors

I

Instituto De Investigación Sanitaria Puerta De Hierro-Segovia De Arana

Lead Sponsor

M

Ministerio de Ciencia e Innovación, Spain

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients must have signed written informed consent.
  • Adults aged 18 years or older at enrollment.
  • Recipients of a single or double lung transplant.
  • Established diagnosis of bronchiolitis obliterans syndrome (BOS) stage 0p or higher within the last 6 months, with FEV1 ≤ 90% and/or FEF 25-75% ≤ baseline value without other causes.
Not Eligible

You will not qualify if you...

  • History of lobar lung transplantation.
  • History of heart-lung transplantation.
  • Active infection at enrollment.
  • Untreated active acute rejection at enrollment.
  • History of cancer except for basal cell carcinoma or carcinoma in situ of the skin.
  • Systemic autoimmune diseases.
  • Active HIV, HBV, or HCV infection confirmed by tests.
  • Proximal airway stenosis.
  • Pregnancy.
  • Performance status 3 or 4 (mostly confined to bed or chair, limited self-care).
  • Estimated survival less than 3 months.
  • Known allergy to components used in MSC production.
  • Any condition that may compromise participation as judged by the investigator.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Hospital Universitario Puerta de Hierro Majadahonda

Madrid, Spain

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

2

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