Effect of autologous Bone Marrow Derived Mesenchymal Stromal Cells prior to Lung Volume Reduction Surgery for Severe Pulmonary Emphysema - a phase I safety and feasibility study

Completed

• Conditions: smokers lungs; soft lungs; 10024967

• Registration Number: NL-OMON33080
• Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 10

Inclusion Criteria

For entry in the study, the following criteria must be met:
a) Men and women over 50 years of age and must have stopped smoking for more than 6 months.
b) Subject is willing to participate in the study and has signed the informed consent.
c) Subject must have emphysema in both lungs demonstrated on a chest CT scan.
d) Subjects must have less than 15% difference in lung density between left and right lung as assessed by PulmCMS software in chest CT scan DICOM files.
e) Subject must have FEV1 below 40% pred (post-bronchodilator).
f) Subject must have a Kco gastransfer factor < 40% pred.
g) Subject must have flat diaphragm as demonstrated on chest film.
h) Patients must be able to adhere to the study visit schedule and protocol requirements.
i) Patient must be willing to participate in a pre-operative rehabilitation protocol.
j) Patients must be able to give informed consent and the consent must be obtained prior to any study procedure.

Exclusion Criteria

a) Patients with clinical and radiological evidence of bronchiectasis.
b) Patients suffering from renal- or hepatic failure.
c) A psychiatric, addictive, or any disorder that compromises ability to give truly informed consent for participation in this study.
d) Use of any investigational drug within 1 month prior to screening
e) Patients with pulmonary hypertension, with mean PAP above 30 mmHg assessed by ultrasound of the chest or by transoesophageal ultrasound.
f) Documented HIV infection.
g) Active hepatitis B, hepatitis C or TB.
h) Subjects who currently have or who have had an opportunistic infection (e.g., herpes zoster [shingles], cytomegalovirus, Pneumocystis carinii, aspergillosis, histoplasmosis, or mycobacteria other than TB) within 6 months prior to screening.
i) Current signs or symptoms of severe, progressive or uncontrolled renal, hepatic, hematologic, gastrointestinal, endocrine, cardiac, neurologic, or cerebral disease (including demyelinating diseases such as multiple sclerosis).
j) Malignancy within the past 5 years (except for squamous or basal cell carcinoma of the skin that has been treated with no evidence of recurrence).
k) History of lymphoproliferative disease including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy of unusual size or location (such as nodes in the posterior triangle of the neck, infra-clavicular, epitrochlear, or periaortic areas), or splenomegaly.
l) Known recent substance abuse (drug or alcohol).
m) Poor tolerability of venapuncture or lack of adequate venous access for required blood sampling during the study period.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Safety and feasibility of intravenous infusion of two doses of BM-MSC with 1 wk<br /><br>interval after the first LVRS and prior to a second LVRS. Safety will be<br /><br>evaluated according to WHO criteria and in addition change in outcome of lung<br /><br>function by the surgery and MSC treatment will be compared with a cohort of<br /><br>LUMC patients treated by lungvolumereduction surgery in LUMC and of whom<br /><br>similar lung function data were obtained.</p><br>