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Cell Therapy Associated With Endobronchial Valve

Study acronym: CEL&VAL
StatusRecruiting
PhasePhase 2/3
Started
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Record History

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  1. Notable Trial status: Not Yet Recruiting to Recruitingv4 Show 5 more changesShow less
    • Primary completion date changed from estimate of Nov 30, 2019 to Aug 17, 2020
    • Study sites: 0 to 1
    • Study completion date: Feb 28, 2021 to Apr 30, 2029
    • Start date changed from estimate of Nov 4, 2019 to Nov 19, 2019
    • Eligibility criteria expanded, about 37 words
  2. Notable Start date: Aug 5, 2019 to Nov 4, 2019
    • Eligibility criteria revised
    v3
  3. Notable Primary endpoints revised (5)v2
  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Chronic obstructive pulmonary disease (COPD) is one of the most common diseases worldwide and is considered a public health problem. The World Health Organization estimates that about 210 million people have COPD. Disease-related mortality is more than 3 million, representing 5% of all deaths, 90% of this mortality being concentrated in middle- and low-income countries. COPD can be subdivided into chronic bronchitis and emphysema. Emphysema, the focus of this project, is histologically defined by the permanent increase of the distal air spaces to the terminal bronchioles associated with the destruction of the alveolar septa in the lung. Approximately two-thirds of adult men and a quarter of women (most without dysfunction) will have well-defined emphysema, but often of limited extent. Mesenchymal stem cells (MSCs) have anti-inflammatory, anti-fibrotic, microbicide and repair potential. Regarding COPD, several authors have concentrated efforts in the investigation of the relationship between the severity of the condition and the various sources of adult stem cells. Apparently the lungs have a high chemotactic effect in relation to adult stem cells, since several studies have evidenced a high implantation (6-20%) of stem cells derived from bone marrow, administered systemically, in the pulmonary tissue of receptors. Therefore, MSCs has been tested in different lung diseases have no effective treatment, such as pulmonary fibrosis, acute respiratory distress syndrome, asthma, COPD positive results, such as reduction of fibrosis, reduction of proliferation inflammatory cells and cytokines, reduction of infectious processes and recovery of the histological changes caused by pulmonary emphysema. Based on these findings, the purpose of this project is to evaluate the safety and efficacy of endoscopic administration of bone marrow stem cells in patients with severe homogeneous emphysema and evaluating the feasibility, efficacy and safety of this procedure.
Trial Details
NCT Number NCT04018729
Lead Sponsor Hospital de Clinicas de Porto Alegre
Collaborators: Pontifícia Universidade Católica do Paraná, Universidade Federal do Rio de Janeiro
Conditions
(from sponsor)
Chronic Obstructive Pulmonary Disease Severe
Enrollment 34 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov