COPD Stem Cell Studies - Chronic Obstructive Pulmonary Disease

Chronic obstructive lung disease (COPD) describes a group of lung conditions (diseases) that make it difficult to empty the air out of the lungs. This difficulty can lead to shortness of breath (also called breathlessness) or the feeling of being tired. COPD is a word that can be used to describe a person with chronic bronchitis, emphysema or a combination of these. COPD is a different condition from asthma, but it can be difficult to distinguish between COPD and chronic asthma.

The most common cause of COPD is cigarette smoking, but there are many other causes. Inhaling smoke or air pollutants can cause the mucus glands that line the bronchial tubes (bronchi) to produce more mucus than normal, and can cause the walls of the bronchi to thicken and swell (inflame). This increase in mucus causes you to cough, frequently resulting in raising mucus (or phlegm). COPD can develop if small amounts of these irritants are inhaled over a long period of time or if large amounts are inhaled over a short period of time.

Environmental factors and genetics may also cause COPD. For example, heavy exposure to certain dusts at work, chemicals and indoor or outdoor air pollution can contribute to COPD. The reason why some smokers never develop COPD and why some non-smokers get COPD is not fully understood. Family genes or heredity probably play a major role in who develops COPD.

There are 4 stages of COPD. They are :

• Stage I (Mild)
  May not be aware of symptoms. Underlying problems may go undetected
  Chronic Cough
  Excess mucus production
• Stage II (Moderate)
  Increased difficulty breathing
  Chronic cough and mucos production
• Stage III (Severe)
  Exacerbations (the medical term for sudden, sever symptoms) become more common
  Fatigue(feeling tired or exhausted) or less able to excercise
  Increased difficulty breathing
  Chronic cough and mucus production with wheezing and chest tightness
• Stage IV (Very Severe)
  Sever breathlessness
  Excacerbations may become life-threatning
  Weight Loss

The diagnosis of COPD depends upon the presence of one or more of the symptoms of the disease.

• Persistent Cough
• Increased mucus or phlegm production
• Wheezing
• Chest tightness
• Fatigue
• Headache
• Twitching
• Swelling
• Dyspnea; shortness of breath, difficult or labored breathing
• Tachypnea; rapid breathing rate
• Need for Oxygen
• Inability to preform house hold tasks
• Inability to climb stairs
• Inability to walk
• Trouble caring for yourself
• Anxiety or Panic

The following are facts cited from the American Lung Association(www.lungusa.org) and U.S. Centers for Disease Control and Prevention(www.cdc.gov)

• Chronic obstructive pulmonary disease (COPD) is an umbrella term for progressive lung diseases, including chronic bronchitis and emphysema, that are characterized by obstruction to airflow that interferes with normal breathing. In 2008, 13.1 million U.S. adults (ages 18 and over) were estimated to have COPD. However, close to 24 million U.S. adults have evidence of impaired lung function, indicating an under diagnosis of COPD. (American Lung Association)
• In 2008, an estimated 9.8 million Americans reported a physician diagnosis of chronic bronchitis, the inflammation and eventual scarring of the lining of the bronchial tubes. Chronic bronchitis affects people of all ages, although people age 65 and older have the highest rate at 56.3 per 1,000 population.
• Females are about twice as likely to be diagnosed with chronic bronchitis as males. In 2008, 3.1 million males had a diagnosis of chronic bronchitis compared with 6.7 million females.
• Years of exposure to the irritation of cigarette smoke usually precede the development of emphysema, which irreversibly damages the air sacs of the lungs and results in permanent “holes” in the tissues of the lower lungs. Of the estimated 3.7 million Americans diagnosed with emphysema, 94 percent are 45 or older.
• Historically, men have been more likely than women to receive a diagnosis of emphysema. However, in 2008 more women (more than 2 million) reported a diagnosis of emphysema than men (almost 1.8 million).
• Smoking is the primary risk factor for COPD. Approximately 85 percent to 90 percent of COPD deaths are caused by smoking. Female smokers are nearly 13 times as likely to die from COPD as women who have never smoked. Male smokers are nearly 12 times as likely to die from COPD as men who have never smoked.
• COPD is the third leading cause of death in America, claiming the lives of 137,693 Americans in 2008. That was the ninth consecutive year in which women exceeded men in the number of deaths attributable to COPD. In 2008, more than 71,000 females died compared to nearly 66,000 males. (US Centers for Disease Control)
• An American Lung Association survey revealed that half of all COPD patients (51 percent) say their condition limits their ability to work. It also limits them in normal physical exertion (70 percent), household chores (56 percent), social activities (53 percent), sleeping (50 percent), and family activities (46 percent).
• In 2010, the cost to the nation for COPD was estimated to be approximately $49.9 billion, including $29.5 billion in direct health care expenditures, $8.0 billion in indirect morbidity costs, and $12.4 billion in indirect mortality costs

Stem cells are unprogrammed cells in the human body that can be described as "shape shifters." These cells have the ability to change or “differentiate” into other types of cells. Stem cells are at the center of a new field of science called regenerative medicine. Because stem cells can become bone, muscle, cartilage and other specialized types of cells, they have the potential to treat many diseases, including Parkinson's, Alzheimer's, COPD, Diabetes and more.

StemGenex offers stem cell therapy using Adult stem cells only. There are four known types of stem cells:

• Adult Stem Cells - derived from the adult human body
  The use of adult stem cells in research and therapy is not as controversial as the use of embryonic stem cells, because the production of adult stem cells does not require the destruction of an embryo. Additionally, in instances where adult stem cells are obtained from the intended recipient, the risk of rejection is essentially non-existent. Consequently, more US government funding is being provided for adult stem cell research. This is why StemGenex offers stem cell studies using Adult stem cells only.
• Embryonic Stem Cells - derived from embryos
  These cells require specific signals to differentiate to the desired cell type. If they are simply injected directly, they will differentiate into many different types of cells, resulting in a tumor derived from this abnormal pluripotent cell development (a teratoma). The directed differentiation of ES cells and avoidance of transplant rejection are just two of the hurdles that ES cell researchers still face. StemGenex does not use embryonic stem cells.
• Fetal Stem Cells - derived from aborted fetuses
  Have developed further than embryonic stem cells and are a little more specialized – their options are slightly more limited. However, they can still produce most types of cell in the body. StemGenex does not use fetal stem cells.
• Induced Pluripotent Stem Cells (iPSCs) - from some parts of the human body
  These stem cells are engineered from older, fully specialized cells – for example, skin cells, which are limited naturally to being only skin cells. Scientists encourage these limited cells to act like embryonic stem cells again, with the ability to become any type of human cell. This is a complex technique that has only recently been developed and is the subject of much ongoing research. StemGenex does not use induced pluripotent stem cells.

Stem cell therapy is an intervention strategy that introduces new adult stem cells into damaged tissue in order to treat disease or injury. Many medical researchers believe that stem cell treatments have the potential to change the face of human disease and alleviate suffering. The ability of stem cells to self-renew and give rise to subsequent generations with variable degrees of differentiation capacities, offers significant potential for generation of tissues that can potentially replace diseases and damaged areas in the body, with minimal risk of rejection and side effects.

StemGenex is currently studying adipose stem cell therapy as a new alternative treatment to help manage the complications of COPD. The stem cells harvested from a patient have the potential to replace countless cells of the body, lung tissue included. These stem cells may heal the body by replacing ones plagued with disease, regenerating new cells, and suppressing the immune systems macrophage response which engulf and digest the dying cells of the lungs. Current research in adult stem cell therapy has shown that restoration of damaged cells through this treatment is possible. This breakthrough in regenerative medicine shines a light of hope on those battling this degenerative disease. Improvements have been seen in the following symptoms after treatment:

• Reduction of dyspnea (difficult or labored breathing)
• Increased energy
• Increase in the ability to walk alone
• Increase in the ability to perform daily tasks
• Reduction of reliance on supplemental oxygen
• Improvements in sleep patterns
• Enhanced mood

StemGenex is studying potential ways to directly target the conditions and complications themselves. These studies consist of multiple ways to deliver the highest amount of activated stem cells to the areas patients need them most. When stem cells are studied through StemGenex, as potential therapy for COPD, there are multiple ways they can be administered:

• Intravenous – injected into the vein
• Stem Cell Nebulization – A process in which the stem cells are broken down into a nebulized state so that they can be inhaled by the patient to directly target the lungs.

Yes. Scientists around the world believe there is enough evidence to suggest that stem cells hold real potential as a therapy for COPD. This evidence comes from research in animals and from a handful of early clinical trials. They believe that it is now time for a concerted effort in stem cell research and an international effort to support clinical trials of stem cells for COPD.

No. There are currently no FDA approved stem cell therapies for COPD disease. All stem cell therapies for COPD disease are currently ‘unproven’, ‘experimental’ therapies. This means that the FDA does not know whether stem cells are effective for people with COPD disease. The only way to determine the effectiveness of stem cell therapy is through the type of clinical studies and trials which are currently being conducted in the US.

One of the goals of StemGenex, through our stem cell studies, is to understand what a particular stem cell therapy might be able to achieve. For example, does it have the potential for slowing the disease's progression, replacing damaged cells and memories, or both? With this goal in mind, StemGenex continues to study these diseases and the full effect of stem cell therapy on each disease. Anecdotally, these results have been overwhelmingly positive but there is more that needs to be done to determine the exact effectiveness of these therapies.

After stem cells have been administered into someone’s body they have to make their way to the correct place (e.g. area of damage) and then have their desired effect. This process takes time and although it is difficult to predict exactly how long, it is likely that it will take several weeks or months on average to see the full desired effect.

Yes, a stem cell therapy may be repeated. Current studies indicate the strong possibility of a cumulative effect from multiple stem cell therapies a patient received for their condition. Long-term studies will attempt to better understand this in detail.

We don’t know yet. This will not be studied in early clinical trials, as this would make it very difficult to measure the true effects of the stem cell therapy. However, a combination therapy may be effective for COPD and is likely to be studied in the future.