Pulmonary Emphysema Clinical Trial
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 Pulmonary Emphysema
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 life and stability of functional parameters at 12 months after starting treatment
One of the problems of MSC transplantation in patients with respiratory failure is an
accelerated apoptosis of transplanted cells under the influence of proinflammatory cytokines
and oxidative stress. Since it is proved that preconditioning MSCs under hypoxia increases
their survival in hypoxic conditions, increases the expression of growth factors and
antiinflammatory cytokines, we suppose that MSCs grown in hypoxic medium may have a
significant positive effect on the disease.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT00995852 -
Unilateral Versus Bilateral Endoscopic Lung Volume Reduction A Comparative Case Study
|
Phase 2/Phase 3 | |
| Completed |
NCT01860898 -
A Phase I Study of iPS Cell Generation From Patients With COPD
|
N/A | |
| Completed |
NCT00123422 -
Innovation in Pulmonary Rehabilitation
|
N/A | |
| Recruiting |
NCT02879331 -
Clinical Study to Evaluate the Exercise Capacity in Patients With Severe Emphysema Treated With Coils
|
N/A | |
| Completed |
NCT01507415 -
Do the SPPB and 4-metre Gait Speed Predict Hospital Readmission in Patients Hospitalised for Acute Exacerbation if COPD?
|
N/A | |
| Completed |
NCT01051258 -
AeriSeal System for Lung Volume Reduction
|
Phase 1/Phase 2 | |
| Completed |
NCT00680056 -
Add-on Effects of Tiotropium Over Formoterol in Exercise Tolerance on Chronic Obstructive Pulmonary Disease Patients
|
Phase 4 | |
| Completed |
NCT01872624 -
Safety Study of Bone-marrow Derived Mesenchymal Stromal Cells Associated With Endobronchial Valves in Emphysema
|
N/A | |
| Completed |
NCT01110252 -
Safety Study of Cell Therapy to Treat Chronic Obstructive Pulmonary Disease
|
N/A | |
| Completed |
NCT00517998 -
Israeli Biologic Lung Volume Reduction (BLVR) Phase 1 Emphysema Study
|
Phase 1 | |
| Terminated |
NCT00205920 -
Netherlands 10 mL Bronchoscopic Lung Volume Reduction (BLVR) Phase 1/2 Emphysema Study - Initial Formulation
|
Phase 2 | |
| Completed |
NCT01869205 -
The Effect and Mechanism of Bronchoscopic Lung Volume Reduction by Endobronchial Valve in Korean Emphysema Patients
|
Phase 3 | |
| Terminated |
NCT01320566 -
A Continuation Study of the AeriSeal® System Administered at 3 to 4 Sites During a Single Treatment Session for Lung Volume Reduction in Patients With Advanced Emphysema
|
Phase 2/Phase 3 | |
| Completed |
NCT00683722 -
PROCHYMAL™ (Human Adult Stem Cells) for the Treatment of Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)
|
Phase 2 | |
| Active, not recruiting |
NCT04465461 -
Video Assisted Thoracic Surgery (VATS) Fissure Completion Prior to Zephyr® Endobronchial Valve Insertion
|
N/A | |
| Completed |
NCT04012359 -
Description of Bullous Emphysema Using Lung Ultrasound and Comparison to the Characteristics of Pneumothorax
|
||
| Recruiting |
NCT04918706 -
Allogeneic MSC Treatment for Pulmonary Emphysema
|
Phase 2 | |
| Terminated |
NCT01449292 -
Study of the AeriSeal System for HyPerInflation Reduction in Emphysema (ASPIRE)
|
Phase 3 | |
| Completed |
NCT00347659 -
US 10 mL Biologic Lung Volume Reduction (BLVR) Phase 1 Emphysema Study
|
Phase 1 | |
| Recruiting |
NCT02827721 -
Evaluation of Novel Lung Function Parameters in Patients With Chronic Obstructive Pulmonary Disease (COPD)
|