Intravenous experimental treatment of pulmonary emphysema with patients own bone marrow-derived and cultured mesenchymal stromal cells.

Phase 1

• Conditions: Pulmonary emphysema; Therapeutic area: Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09]

• Registration Number: EUCTR2017-001853-15-NL
• Lead Sponsor: eiden University Medical Center

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-04-30
• Last Update Posted: 26 November 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

In order to be eligible to participate in this study, a subject must meet all of the following criteria:

-Age lower than 65;
-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;
-FEV1 between 25% and 45% pred ;
-TLCO between 30% and 45% pred.;
-patients in a stable clinical condition.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

A potential subject who meets any of the following criteria will be excluded from participation in this study:

-Significant cardiac failure; or active smoking, or
-< 6 months smoking cessation;
-or failure to complete pulmonary rehab program before randomization;
-or women of child bearing potential;
-or any other condition of the patient that the clinical investigator deemed harmful for study participation.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified