NL-OMON33080
Completed
Not Applicable
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 - - Safety of autologous mesenchymal stemcells on severe pulmonary emphysema
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- smokers lungs
- Sponsor
- eids Universitair Medisch Centrum
- Enrollment
- 10
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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.
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).
Outcomes
Primary Outcomes
Not specified
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