Mesenchymal Stem Cells in the Treatment of Subjects with Advanced Chronic Obstructive Pulmonary Disease (COPD)

 A currently recruiting study being done by The Mayo Clinic that seeks into understanding the effects of mesenchymal stem cell therapy in patients with advanced chronic pulmonary disease (COPD). It is a single group assignment with the procedure including a single dose of MSC’s intravenously. The only primary outcome is to measure adverse effects.

https://clinicaltrials.gov/ct2/show/NCT04047810?id=NCT04047810+OR+NCT02216630+OR+NCT02341326+OR+NCT01110252+OR+NCT03044431+OR+NCT00683722+OR+NCT02348060+OR+NCT03040674&draw=2&rank=1&load=cart

 

An Observational Outcomes Study for Autologous Cell Therapy Among Patients with COPD and Interstitial Lung Disease

 A recruiting study being done by the Lung Institute that hopes to increase the advancement of stem cell therapy for COPD patients. For this particular study, the researchers say they “aim to confirm the safety of autologous cell therapy, explore the effects of autologous cell therapy treatment on pulmonary function, and to describe the anecdotal quality of life changes of patients following treatment…”. This is a follow-up study to a similar already completed trial.

This trial is an observational cohort study including the harvesting of stem cells from either bone marrow or peripheral blood, and same day peripheral circulation treatment to return the stem cells back to the body after processing. The outcome measures include estimating quality of life for up to six months, changes in MMRC scale, and change in FEV1 from baseline.

https://clinicaltrials.gov/ct2/show/NCT03040674?id=NCT02216630+OR+NCT02341326+OR+NCT01110252+OR+NCT03044431+OR+NCT00683722+OR+NCT02348060+OR+NCT03040674&draw=2&rank=2&load=cart

 

Outcome Data of Adipose Stem Cells to Treat Chronic Obstructive Pulmonary Disease

 A recruiting study being done by StemGenex that wants to determine the impact that treatment with stromal vascular fraction has on patients suffering from COPD. It is an observational study with the outcomes including measuring quality of life, breathing comfort, fatigue, and emotional function.

https://clinicaltrials.gov/ct2/show/NCT02348060?id=NCT02216630+OR+NCT02341326+OR+NCT01110252+OR+NCT03044431+OR+NCT00683722+OR+NCT02348060&draw=2&rank=2&load=cart

 

Defective FGFR2 Signaling in the Small Airway Basal Progenitor Cells in COPD

 This recruiting study being done by Weill Medical College of Cornell University focuses on the SAE cells in the lungs that obstruct airways for early COPD patients. Fibroblast growth factor receptor 2 (FGFR2) is essential for the stability of lung functioning in the SAE; which can be depleted from cigarette smoking. In this study, researchers will evaluate and compare the SAE and lungs of smokers versus nonsmokers.

This is an observational case-control study that will study whether cells in the SAE of smokers have reduced capacity to generate normally, and to also initiate airway branching and repair in response to injury. This study also aims to test their hypothesis that FGFR2 signaling is necessary for normal SAE stem cell function and suppression of it caused by inhibitors leads to altered cell function similar to COPD.

https://clinicaltrials.gov/ct2/show/NCT02341326?id=NCT02216630+OR+NCT02341326+OR+NCT01110252+OR+NCT03044431+OR+NCT00683722&draw=2&rank=2&load=cart

Autologous Stem Cell Treatment for Chronic Lung Disease Study

 A completed study from the Lung Institute that aims to describe the safety and efficacy of autologous stem cell treatment while also seeking out long term effects of treatment, and measuring quality of life. It is an observational study including harvesting stem cells from either the peripheral blood or the patient’s bone marrow, and returning cells later that same day after processing (similar to their recruiting study mentioned earlier).

This study came back with results. Of their 207 participants, 148 completed the study all the way to its final endpoint. Most of the patients underwent the transfusion of peripheral blood, while the other patients used stem cells from their bone marrow. The patients did a questionnaire whereby on a scale of 0-6, the mean score was 3.6 of how severe their symptoms were after treatment and quality of life. The study reports that there were no adverse events that happened after treatment, no deaths caused by treatment, and only 10 patients reported non-serious adverse events after treatment not caused by treatment.

This study shows great improvement for treating COPD patients; the researchers believe this study proves it is a viable source of treatment and more studies should be done to confirm it.

https://clinicaltrials.gov/ct2/show/results/NCT03044431?id=NCT02216630+OR+NCT01110252+OR+NCT03044431+OR+NCT00683722&draw=2&rank=1&load=cart

 

Safety and Efficacy of Adipose Derived Stem Cells for Chronic Obstructive Pulmonary Disease

 This is a completed study done by Kimera Society Inc. that uses adipose-derived stem cells in treatment for COPD patients. The researches aim to investigate the “immunosuppressive potential of the non-manipulated non-cultured stromal vascular fraction obtained via liposuction”.

The procedure includes extracting 100cc of fat from each patient, isolating the stem cells, and delivering them back to the body intravenously. The outcome measures include monitoring the decline of forced evacuation volume (FEV1) and the number of adverse events post treatment for up to 12 months. The results of this experiment have not yet been posted.

https://clinicaltrials.gov/ct2/show/NCT02216630?id=NCT02216630+OR+NCT01110252+OR+NCT00683722&draw=2&rank=1&load=cart

 

Safety Study of Cell Therapy to Treat Chronic Obstructive Pulmonary Disease (COPD-01)

A completed study done by UPECLIN HC FM Botucatu Unesp that uses bone marrow mononuclear cells in the treatment of COPD, specifically pulmonary emphysema. The main threat about pulmonary emphysema is that it obstructs airflow due to the deterioration of the alveolar walls. Normal treatment for this typically includes surgery; however, there is a lack of donors in this field of treatment.

With that, the main objective of this experiment is to study the effects of using stem cell therapy and to gain more knowledge of the field. This study is a single group assignment with the procedure involving an evaluation on each patient’s health while also harvesting the stem cells to prepare for injection. After injection, the researchers measure the volume and speed of air flow in the body, along with other lung capacity objectives.

This study had 4 participants; all had completed the study. The results posted show that all 4 patients safely received the dosage of stem cells with no adverse effects reported after. In biological tests, the number of CO2 in the blood spiked higher on average for the four patients while the oxygen levels decreased as well as decreased levels of vital capacity. On the other hand, the levels for forced vital capacity when up.

https://clinicaltrials.gov/ct2/show/NCT01110252?id=NCT01110252+OR+NCT00683722&draw=2&rank=1&load=cart

 

PROCHYMAL™ (Human Adult Stem Cells) for the Treatment of Moderate to Severe Chronic Obstructive Pulmonary Disease (COPD)

Here is a completed study done by Mesoblast Inc., their primary objective of this study is to establish safety and efficacy in using their creation of PROCHYMAL stem cells in order to treat COPD. The researchers stand against primary treatment options of COPD such as oxygen therapy through bronchodilators and inhaled corticosteroids since these measures “do not provide any significant benefit regarding disease progression or prognosis.”

This is a randomized parallel assignment where one group of participants will receive PROCHYMAL via intravenous infusion and another group of participants will receive a placebo via intravenous infusion. Both groups received four monthly injections and were followed for up to two years. The main outcomes of this experiment include measuring any and all adverse effects, pulmonary function testing, and quality-of-life indicators.

74% of all participants completed the two-year follow-up. There were no toxicities, deaths, or any other adverse events related to treatment. However, there was also no significant difference between quality-of-life indicators in the groups. One major change though, was that there was a significant decrease in levels of circulating C-reactive proteins in patients who received MSC’s. Researchers concluded that administering MSC’s to treat COPD is a safe alternative to primary treatment and that this study provided a good basis for future studies.

https://clinicaltrials.gov/ct2/show/NCT00683722?id=NCT00683722&draw=2&rank=1&load=cart

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