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Study on the Safety of Allogeneic Mesenchymal Stromal Cells for Patients with Chronic Lung Transplant Rejection

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a condition known as chronic lung transplant rejection, which can occur in patients who have received a lung transplant. The study is investigating a treatment using a special type of cells called allogeneic mesenchymal stromal cells. These cells are derived from bone marrow and are expanded outside the body before being used. The treatment involves administering these cells directly into the lungs through a procedure called endobronchial administration.

The main purpose of the study is to assess the safety of this cell-based treatment in patients who have experienced chronic rejection after a lung transplant. Participants in the study will receive either the cell treatment or a placebo. The study will monitor participants for any side effects or adverse reactions, such as changes in breathing or infections, following the administration of the cells. The study will also track the progression of the lung condition over time.

Participants will be followed for a period of time to observe any changes in their lung function and overall health. The study aims to provide valuable information on whether this new treatment can help manage chronic lung transplant rejection safely. The results could potentially lead to new treatment options for patients experiencing this challenging condition.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, the patient must have signed a written informed consent.
The patient must be an adult, 18 years or older, who has received a lung transplant, either one lung or both.
The patient must have a diagnosis of bronchiolitis obliterans syndrome (BOS) with specific lung function criteria in the last 6 months.
Step 2
Treatment administration
The treatment involves the administration of a product called PDH-MSC-TxP, which contains allogeneic bone marrow-derived mesenchymal adult stromal cells.
The product is given as a suspension for injection through endotracheopulmonary use, meaning it is delivered directly into the lungs.
Step 3
Monitoring for adverse events
The patient will be monitored for any early onset adverse events within 24 hours after receiving the treatment. These may include desaturation, hypotension, radiological infiltrates, fever, or changes in oxygen therapy requirements.
The patient will also be observed for adverse events of special interest, such as lower respiratory tract infections, acute rejection, or worsening of BOS.
Step 4
Follow-up assessments
The patient's lung function will be assessed over a 12-month period to measure changes in FEV1, which is a test that measures how much air can be forcefully exhaled in one second.
Other assessments include the proportion of patients with significant decreases in lung function, time to decrease in lung function, progression to more severe stages of BOS, and overall mortality rates.
Additional evaluations will include the presence of specific antibodies against donor HLA, progression of chronic lung allograft dysfunction (CLAD), changes in the mMRC scale, total hospitalization days, and the need for ambulatory oxygen therapy.

Who can join the trial?

4 criteria

Patients must have signed a written informed consent, which means they agree to participate in the study after understanding all the details.
Patients must be adults, which means they are **18 years or older** at the time they join the study.
Patients must have received a lung transplant, either one lung (**unilateral**) or both lungs (**bilateral**).
Patients must have a confirmed diagnosis of **BOS** (Bronchiolitis Obliterans Syndrome) at a level of **0p** or higher. This means their lung function tests show specific results: **FEV1** (Forced Expiratory Volume in 1 second) is **90% or less** of the expected value, and/or **FEF 25-75%** (Forced Expiratory Flow at 25-75% of the pulmonary volume) is **less than or equal to** the baseline value, with no other cause explaining these results. This diagnosis must have been made in the last **6 months**.

Who cannot join the trial?

5 criteria

Patients who have not had a lung transplant.
Patients who do not have an established diagnosis of BOS (Bronchiolitis Obliterans Syndrome) with specific lung function criteria in the last 6 months.
Patients who are not within the specified age range for the study.
Patients who are not part of the specified clinical trial group.
Patients who are part of a vulnerable population, which means they might need special protection or care.

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Verified sites

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Hospital Universitario Puerta De Hierro De Majadahonda
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Majadahonda, Spain

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Investigated drugs

Allogeneic Mesenchymal Stromal Cells (MSCs) are cells derived from a donor that are used in this trial to evaluate their safety when administered directly into the airways of patients. These cells have the potential to help repair and regenerate damaged tissues, and in this study, they are being tested for their ability to improve lung function in patients who have undergone a lung transplant and are experiencing chronic rejection.

Allogeneic Bone Marrow-Derived Mesenchymal Adult Stromal Cells, Ex-Vivo Expanded

What is already known about the treatment

Allogeneic Mesenchymal Stromal Cells (MSCs) – This medication is administered endobronchially, meaning it is delivered directly into the airways. It is currently being studied in clinical trials to evaluate its safety for patients who have undergone lung transplants and are experiencing chronic rejection, specifically bronchiolitis obliterans syndrome (BOS). The main therapeutic indication is to potentially treat or manage BOS in these patients. At the molecular level, MSCs are believed to work by modulating the immune response and promoting tissue repair. They are classified pharmacologically as a type of cell therapy.

Investigated diseases

Bronchiolitis Obliterans Syndrome (BOS) – This condition occurs in patients who have undergone a lung transplant, either unilateral or bilateral. It is characterized by a decline in lung function, specifically a decrease in the forced expiratory volume in one second (FEV1) and/or forced expiratory flow (FEF) 25-75% from baseline values. The disease progresses as the airways become increasingly obstructed, leading to breathing difficulties. Over time, patients may experience worsening symptoms, including a further decline in lung function. The condition is often monitored by measuring changes in FEV1 and other lung function parameters. BOS can lead to significant respiratory issues if not managed properly.