Clinical Trial: Clinical Study of the Efficacy and Safety of the Application of Allogeneic Mesenchymal (Stromal) Cells of Bone Marrow, Cultured Under the Hypoxia in the Treatment of Patients With Severe Pulmonary Emphysema

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: Clinical Study of the Efficacy and Safety of the Application of Allogeneic Mesenchymal (Stromal) Cells of Bone Marrow, Cultured Under the Hypoxia in the Treatment of Patients With Severe Actively developing stem cells (SCs) transplantation techniques cause natural interest to the problem of regeneration in the lungs. Numerous experimental studies proved the benefits of different types of SCs in experimental models of pulmonary emphysema (PE).

G. Zhen et al. have shown that the transplantation of mesenchymal stem cells (MSCs) to rats with papain-induced emphysema leads to their migration into the lungs, differentiation into type 2 alveolocytes, and inhibition of apoptosis and prevention PE.

K. Schweitzer et al. have proved the activity of inflammation in the airways, alveolocytes and endothelial cells apoptosis decreased after adipose SCs intravenous administration to mice with emphysema caused by chronic exposure to tobacco smoke or VEGF receptors blockade. The study of E.P. Ingenito et al. found that endobronchial installed MSCs engraft into the alveolar wall and peribronchial interstitium and release integrins, extracellular matrix components (collagen IV, laminin and fibrillin), platelet-derived growth factor receptor and transforming growth factor β2.

Our study also found reliable deterrent effect of allogeneic bone marrow MSCs on the development of elastase-induced emphysema in rats at different terms of transplantation.

After the success of pilot studies have started clinical trials. Currently, the website http://www. ClinicalTrials.gov reported three studies evaluating the efficacy and safety of MSC transplantation in patients with COPD and emphysema. Two of them have already been completed and the results of the first pilot project published.

Authors on the example of 4 patients showed a complete absence of adverse effects, improved quality of li

Detailed Summary:
Sponsor: Federal Research Clinical Center of Federal Medical & Biological Agency, Russia

Current Primary Outcome: Safety compared with placebo [ Time Frame: 1 year ]

Mortality (Baseline and 2 years after procedure) Adverse effects and reactions to the treatment(Baseline and 2 years after procedure).

Vital signs (pulse rate, systolic and diastolic arterial blood pressure) (Baseline and 2 years after procedure)



Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Change from baseline in the lung tissue density measured by CT-densitometry at6, 12, 24 months [ Time Frame: 2 years ]
  • DLCO change from baseline at 6, 12, 24 months [ Time Frame: 2 years ]
  • Change from baseline in the functional parameters (FEV1, TLC, RV, FEV1/FVC) at 6,12,18,24 months [ Time Frame: 2 years ]
  • Dynamics of the physical capacity (by the 6-min test results) [ Time Frame: 2 years ]
  • Dynamics of the blood gas composition (PaO2, PaCO2) [ Time Frame: 2 years ]
  • Dynamics of serum level IL-6, TNF-α, Leptin [ Time Frame: 2 years ]
  • Quality of life indices by the questionnaire (SF-36) [ Time Frame: 2 years ]
  • Number and frequency of exacerbations [ Time Frame: 2 years ]
  • Body mass index [ Time Frame: 2 years ]


Original Secondary Outcome: Same as current

Information By: Federal Research Clinical Center of Federal Medical & Biological Agency, Russia

Dates:
Date Received: April 24, 2013
Date Started: March 2014
Date Completion: June 2017
Last Updated: October 26, 2015
Last Verified: October 2015