Emphysema Clinical Trial
Official title:
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
The purpose of this study is to show safety and feasibility to administer patients own mesenchymal stem cells to show signs of repair of emphysematous lung tissue
Status | Completed |
Enrollment | 10 |
Est. completion date | November 2012 |
Est. primary completion date | June 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 40 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Class GOLD III for COPD Exclusion Criteria: - Patients with clinical and radiological evidence of bronchiectasis. - Patients suffering from renal- or hepatic failure. - A psychiatric, addictive, or any disorder that compromises ability to give truly informed consent for participation in this study. - Use of any investigational drug within 1 month prior to screening. - Patients with pulmonary hypertension, with mean PAP above 30 mmHg assessed by ultrasound of the chest or by transoesophageal ultrasound. - Documented HIV infection. - Active hepatitis B, hepatitis C or TB. - Subjects who currently have or who have had an opportunistic infection (e.g., herpes zoster, cytomegalovirus, Pneumocystis carinii, aspergillosis, histoplasmosis, or mycobacteria other than TB) within 6 months prior to screening. - 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). - 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). - 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. - Known recent substance abuse (drug or alcohol). - Poor tolerability of venepuncture or lack of adequate venous access for required blood sampling during the study period. |
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Netherlands | Department of Pulmonology, Leiden University Medical Center | Leiden |
Lead Sponsor | Collaborator |
---|---|
Leiden University Medical Center |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Participants with Adverse Events as a Measure of Safety and Tolerability | Safety: rate and grade of (serious) adverse events in the study population using the WHO toxicity criteria. After infusion of MSC's investigators will score change in renal function, breathing rate, temperature, heart rate, and blood pressure. Feasibility: determination of the number of expanded MSCs in relation to the amount of autologous bone marrow collected, number of passages required and time to reach to study target dose |
8 weeks | Yes |
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