Status:
UNKNOWN
Allogeneic MSC Treatment for Pulmonary Emphysema
Lead Sponsor:
Leiden University Medical Center
Collaborating Sponsors:
Erasmus Medical Center
Amsterdam UMC, location VUmc
Conditions:
Pulmonary Emphysema
Mesenchymal Stromal Cells
Eligibility:
All Genders
45-65 years
Phase:
PHASE2
Brief Summary
Rationale: Pulmonary emphysema is a component of Chronic Obstructive Pulmonary Disease (COPD) characterized by chronic inflammation with neutrophils and monocytes mediating the tissue destruction unde...
Detailed Description
Rationale: Pulmonary emphysema is a component of Chronic Obstructive Pulmonary Disease (COPD) characterized by chronic inflammation with neutrophils and monocytes mediating the tissue destruction unde...
Eligibility Criteria
Inclusion
- Signed informed consent consistent with ICH-GCP guidelines and local legislation prior to participation in the trial;
- Scheduled for lung volume reduction surgery for emphysema as determined by a referring chest physician;
- Pre-bronchodilator measured FEV1 between 20% and 45% predicted; TLCO between 30% and 45% pred.; RV/TLC ≥ 50%;
- Patients in a stable clinical condition.
Exclusion
- Significant cardiac failure;
- Active smoking, or \< 6 months smoking cessation;
- Failure to complete pulmonary rehab program before randomization
- Women of child bearing potential;
- Any cancer treated in the previous 5 years;
- Women of child-bearing potential not using adequate contraception;
- Any other condition of the patient that the clinical investigator deemed harmful for study participation.
Key Trial Info
Start Date :
June 25 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2022
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04918706
Start Date
June 25 2019
End Date
June 1 2022
Last Update
June 9 2021
Active Locations (1)
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1
Department of Pulmonology, Leiden University Medical Center
Leiden, Netherlands, 2333 ZA