Regenerative Medicine and Chronic Obstructive Pulmonary Disease

Regenerative medicine is the future of medical practices worldwide. A report from the U.S. Department of Health and Human Services entitled “2020: A New Vision— A Future for Regenerative Medicine” discusses that regenerative medicine will be the forefront of 21st-century healthcare. In general, physicians, scientists and others expect that the use of regenerative medicine will enable the repair of injured tissues and damaged organs and a better quality of life for those suffering from debilitating disorders. Due to several advances in the field of regenerative medicine and stem cells therapies, the U.S. National Institutes of Health and National Academies recognize regenerative medicine as one of the most promising components of modern medical practice.

Today, advances such as bone marrow transplants for hematological disorders being the standard of care to bioengineered stem cell platforms for tissue replacement and the production of autologous (from one self) pluripotent stem cells for diagnosis, treatment and therapies is what make regenerative medicine fascinatingv. It is presumed that in the near future stem cells will be able to replace organs. Although stem cells are presently not a cure for many diseases, they may be beneficial in improving the quality of life for those suffering from incurable conditions.

Stem cell treatments are based on the principle of rejuvenation-replacement-regeneration—what is called the R3 effect, vii. In brief, new cells from the same organ/donor (rejuvenation), the transplant of cells (replacement) and ultimately the growth of new tissue (regeneration) contribute to homeostasis in order to improve health or quality of life.This paradigm has been demonstrated through thousands of patients involved in stem cell clinical studies throughout the world on diseases such as acute myocardial infarction to chronic obstructive pulmonary disease (COPD).

It is estimated that there are over 200 million people worldwide affected with COPD and more than 3 million deaths annually. Moreover, within the past decades the prevalence of the disease is on the rise for both men and woman due in part to increased tobacco use. COPD is one of the principal causes of morbidity in the world with an estimated 80 million people having signs of moderate to severe COPD Most importantly it presents a direct and indirect economic burden on those affected by the disease. Presently, there is no cure for COPD with treatments only designed to alleviate symptoms and stop the progression of the illness.

There are various studies demonstrating the use of stem cells for pulmonary disease. For example, in animal models of pulmonary fibrosis it has been demonstrated that stem cells control the progression of disease and reduce pulmonary fibrosis. In addition, other pulmonary disease experimental models have demonstrated that stem cells reduce inflammation and most importantly mortality. In 2009, Osiris (NASDAQ: OSIR) based out of the U.S. commenced clinical studies using stem cells for COPD. These studies are now in phase II clinical trials with the latest results demonstrating a reduction in inflammation in COPD subjects.

Rehealth Regenerative Therapies (Guadalajara, MX) have been collaborating for several years to develop stem cell treatments for COPD. Several years ago, Rehealth initiated the application of stem cells (regenerative therapies) and is approved by the Comision Federal para la Protection de Riesgos Sanitarios (COFEPRIS)—FDA equivalent for Mexico.

They are approved to transplant autologous stem cells isolated from bone marrow (hematopoietic stem cells). The cells are isolated from the iliac crest (hip), purified and transplanted hours later while the patient waits. The patient normally is sent home the same day (outpatient) following vigorous testing.

Rehealth is using a different type of stem cell that has shown promise in various studies. These stem cells which are called mesenchymal stem cells (MSCs) are also isolated from the hip but require a purification and expansion step in a clean/sterile room environment. MSCs require approximately 3-4 weeks to purify, expand and test prior to being transplanted intravenously.

In the field of regenerative medicine, MSCs have been on the forefront for years with more than 17,000 scientific publications. There are hundreds of clinical trials throughout the world using MSCs. Recently, the Korean FDA approved the use of MSCs for acute myocardial infarct. What makes these cells unique and on the forefront of regenerative medicine are its endogenous properties. MSCs have angiogenic properties. This means they can produce new vasculature within our body. In the case of many diseases this can help to provide new blood flow to damaged tissue. This allows the cells to help repair heart, brain and other organs. In the heart, brain and lungs correct blood flow is vital to maintaining health. In addition, the cells release growth factors. These growth factors can aid in the repair of damaged tissue. For example, in diabetes these cells may help damaged cells of the pancreas to produce new insulin and in the case of COPD it may reduce and/or inhibit fibrosis formation in the lungs.

Based upon previous scientific findings and our experience with stem cells, Rehealth is now investigating the use of MSCs for treating COPD. The study will be designed to measure specific parameters found in patients affected with COPD at various time points following our present method of stem cell transplantation and MSCs transplantation. We will measure parameters such as oxygen use, exercise tolerance and the GOLD staging system (disease stages I- IV). Our hopes are to find an alternative standard of care that may be beneficial for those suffering from this debilitating disease.

In summary, autologous stem cells are very promising for several different diseases. It has been demonstrated that stem cells may be an alternative treatment for COPD. Rehealth Regenerative Therapies is addressing the use of stem cells for COPD in defined clinical studies with the goal of improving the quality of life for those affected with this debilitating disease.