COPD emphysema
Conditions
Interventions
The injection of autologeous blood or blood derived products into the
interlobar collateral ventilation channels region to convert CV(+) lobes into
CV(-) lobes.
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Diagnosis of upper or lower lobe heterogeneous emphysema with a difference in heterogeneity of >= 25% in destruction at -950HU between ipsilateral lobes. 2. Subjects of both genders of at least 35 years of age at the time of the baseline visit. 3. Understand and voluntarily sign a patient informed consent form. 4. 15 % predicted = 175% predicted, and TLC >= 100% predicted and RV/TLC >= 55% predicted. 6. 6MWT >= 140 meters. 7. Dyspnea score of >=2 on the mMRC scale of 0-4. 8. Non-smoker > 8 weeks prior to signing the informed consent.
Exclusion criteria
Exclusion criteria: 1. Evidence of active pulmonary infection. 2. Evidence of clinically significant bronchiectasis. 3. History of more than 3 exacerbations with hospitalizations over the past 12 months. 4. Evidence of pulmonary hypertension (sPAP > 45mmHg). 5. Subject has DLCO 8.0kPa, or Hypoxemia defined by PaO2 20mg prednisolon (or equivalent) use/days. 13. Any disease with high probability of mortality within 24 months. 14. Patient is on an antiplatelet agent (such as Plavix) or anticoagulant therapy (such as LMWH or coumarins). 15. Patient was involved in other pulmonary drug studies within 30 days prior to this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility: Evidence of targeted lung volume reduction (TLVR) on CT scan at 1 month Follow Up. | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety: The number and type of procedure-related (serious) adverse events within 3 months after the procedure. Effectiveness: Change in TLVR, lung function, exercise capacity and quality of life at 3 months Follow Up. | — |
Countries
Netherlands
Outcome results
None listed