Safety of Endobronchial Mesenchymal Stromal Cells in the Treatment of Chronic Lung Allograft Dysfunction (ENDOSCLAD)
An Open Label, Randomised, Controlled Clinical Trial to Asses the Safety of Endobronchial Administration of Allogneic Mesenchymal Stromal Cells in Patients With Lung Trasplant Chronic Rejection: Endosclad Study.
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
-
Madrid, Spain
- Recruiting
- Hospital Universitario Puerta de Hierro Majadahonda
-
Contact:
- David Gomez de Antonio, PhD
- Phone Number: +341916623
- Email: dgavm@yahoo.es
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Treatment group
|
Endobronchial administration of 10⁶ MSCs/kg in each transplanted lung, 4 weeks apart.
|
|
No Intervention: Control
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Early onset adverse events
Time Frame: 24 hours
|
Incidence of early onset (24h) adverse events following MSCs administration: desaturation, hypotension, radiological infiltrates, fever or changes in oxygen therapy requirements.
|
24 hours
|
|
Adverse events
Time Frame: One year since randomization
|
Incidence of adverse events of special interest since randomization: lower respiratory tract infections, acute rejection (as defined by the presence of A1-A4 o B1R, B2R in biopsy), BO worsening (as measured by >10% decline in FEV1 from baseline).
|
One year since randomization
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ICI/00122
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.