An explorative study for halting inflammation in patients with emphysema by administration of allogeneic bone marrow derived mesenchymal stromal cells.

Phase 2

Recruiting

• Conditions: 10024967; COPD; stretched lungs

• Registration Number: NL-OMON48907
• Lead Sponsor: ongziekten

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

1.Signed informed consent consistent with ICH-GCP guidelines and local
legislation prior to participation in the trial.
2.Males or females between 45 and 65 years of age;
3.Emphysema as reported by a radiologist present in CT images of the lung;
gradient of emphysema severity towards the lung apex as assessed by CT-derived
lung densitometry by Pulmo CMS software (Medis, NL) and equally distributed
between left and right lung.
4. Pre bronchodilator value measured FEV1 between 20% and 45% predicted; TLCO
between 30% and 45% pred.; RV/TLC > 0.5.
5. Patients in a stable clinical condition.

Exclusion Criteria

1. Significant cardiac failure;
2. active smoking, or < 6 months smoking cessation;
3. or failure to complete pulmonary rehab program before randomization;
4. women of child bearing potential;
5. any cancer treated in the previous 5 years;
6. women of child-bearing potential not using adequate contraception;
7. any other condition of the patient that the clinical investigator deemed
harmful for study participation.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Co-primary outcome parameters are: (1) to detect the difference in expression<br /><br>of PECAM-1 (CD31) on pulmonary microvascular endothelial cells (pMVECs) per<br /><br>micrometer alveolar septum present in lung tissue harvested from patients at<br /><br>LVRS 2 after 4 weeks of treatment with allogeneic MSC or placebo and (2) to<br /><br>measure the difference between MSC and placebo treatment in change in CO<br /><br>diffusion capacity over a period of 3 years following the second LVRS.</p><br>