Status:
WITHDRAWN
Clinical Study of the Efficacy and Safety of the Application of Allogeneic Mesenchymal (Stromal) Cells of Bone Marrow, Cultured Under the Hypoxia in the Treatment of Patients With Severe Pulmonary Emphysema
Lead Sponsor:
Federal Research Clinical Center of Federal Medical & Biological Agency, Russia
Conditions:
Pulmonary Emphysema
Eligibility:
All Genders
35-75 years
Phase:
PHASE1
PHASE2
Brief Summary
Actively developing stem cells (SCs) transplantation techniques cause natural interest to the problem of regeneration in the lungs. Numerous experimental studies proved the benefits of different types...
Eligibility Criteria
Inclusion
- HRCT-confirmed diagnosis of lung emphysema by two independent radiologists
- post-bronchodilator FEV1/FVC ratio \< 0.7
- post-bronchodilator FEV1 % predicted value ≥ 20% and \< 50%
- age 35 and 75 years of, of either sex, and of any race
- current or ex-smoker, with a cigarette smoking history ≥ 10 pack-years
Exclusion
- • asthma or other clinically relevant lung disease other than COPD (e.g. restrictive lung diseases, sarcoidosis, tuberculosis, idiopathic pulmonary fibrosis, or lung cancer)
- α1-Antitrypsin deficiency
- Presence of bullae (more than 10 cm in the diameter)
- active infection within 4 weeks of screening
- significant exacerbation of COPD or has required mechanical ventilation within 4 weeks of screening
- clinically relevant uncontrolled medical condition not associated with COPD
- documented history of uncontrolled heart failure
- pulmonary hypertension due to left heart condition
- Subject has evidence of active malignancy, or prior history of active malignancy
- Subject has a life expectancy of \< 6 months
Key Trial Info
Start Date :
March 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2017
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT01849159
Start Date
March 1 2014
End Date
June 1 2017
Last Update
January 9 2018
Active Locations (1)
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1
Federal Research Clinical Center of Federal Medical and Biological Agency of Russia
Moscow, Moscow Oblast, Russia, 115682