Scientific Background

Chronic neurodegenerative diseases, as diverse as Alzheimer’s disease (AD), Parkinson disease (PD), Multiple Sclerosis (MS), Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), Stroke, Traumatic Brain Injury (TBI), and Amyotrophic Lateral Sclerosis (ALS), just to name a few, share a common thread. That common thread is the destruction of nervous tissue and/or its supportive elements leading to loss of function. This loss of function can be manifested as brain fog, decreased cognition, memory loss, loss of sensation, tremors, shuffling gait, a noticeable decrease in body functions, and/or an inability to move. Current approved pharmacological treatment for these conditions may slow the progression of the disease but do little to halt the disease.

The body contains three categories of cells that are necessary for life. These categories are differentiated cells, progenitor cells, and stem cells. On a developmental pathway stem cells are more primitive than progenitor cells which are more primitive than differentiated cells.

Differentiated cells can be divided into two groups. The first group is called the parenchyma while the second group is called the stroma. The parenchyma is the active functional portion of an organ. Examples of parenchyma of the brain and spinal cord (central nervous system, CNS) and peripheral nervous system (PNS) include nerve cells, ganglion cells, and sensory receptors for pain, temperature, and touch. The stroma functions as the support system for an organ. Examples of stroma of the CNS and PNS include the myelin producing glial cells, loose fibrous connective tissue, and capillaries.

Progenitor cells (“x-blasts”) function to maintain the differentiated cells throughout the life span of an organism. Particular progenitor cells maintain particular differentiated cells. For example, neuroblasts only maintain neurons, glioblasts only maintain glial cells, fibroblasts only maintain the connective tissues, and endothelioblasts only maintain capillaries.

Stem cells can be divided into three general groups. These groups are germ layer lineage stem cells, pluripotent stem cells, and totipotent stem cells. The germ layer lineage stem cells are subdivided into three groups that are based on the development of the individual from conception. These three groups are ectodermal stem cells, endodermal stem cells, and mesodermal stem cells. The ectodermal stem cells only form cells of the CNS and PNS and cells that line or exit to the outside of the body. Examples of these cell types include neurons, ganglion cells, sensory nerve endings, glial cells, the epidermis, hair, the enamel of teeth, and sweat glands. The endodermal stem cells only form cells that line or exit to the inside of the body. Examples of these cell types include the lining cells of the stomach, intestines, lungs, pancreas, and gall bladder. The mesodermal stem cells form the packing tissues (muscle, fat, cartilage, bone, connective tissues, vasculature) in between the ectodermal- and endodermal-derived cells, the immune system (spleen, lymph nodes, lymphatic vessels), the hematopoietic system (red blood cells, macrophages, white blood cells), the urinary system (kidney, urinary bladder), the reproductive system (testes and their associated organs and ovaries and their associated organs), and the cardiovascular system (heart; large, medium and small blood vessels; and capillaries).

Pluripotent stem cells are more primitive on the developmental pathway than germ layer lineage stem cells. They are located in all organs of the body. Pluripotent stem cells have the potential to form all cell types derived from ectodermal stem cells, endodermal stem cells, and mesodermal stem cells, but will NOT form germ cells (sperm or ova) and will NOT form placental tissues.

Totipotent stem cells are the most primitive stem cell on the developmental pathway. They are located in all organs of the body. Totipotent stem cells have the potential to form all cell types derived from ectodermal stem cells, endodermal stem cells, mesodermal stem cells, germ cells (sperm or ova) and placental tissues.

With the advent of the discovery of stem cells generated either from embryonic tissues, induced genetically from differentiated cells or progenitor cells, or endogenous stem cells (i.e., germ layer lineage stem cells, pluripotent stem cells, and totipotent stem cells) located within the individual, has come the proposal to treat debilitating diseases by replacing the diseased or damaged tissues with healthy tissues derived from these different types of stem cells. The use of stem cells generated from embryonic tissues is still an ethical concern to many individuals. Genetically-induced stem cells derived from differentiated cells or progenitor cells are not without their own inherent problems that may be deleterious to the individual. Currently, use of endogenous stem cells offer the most hope with the least risk to the individual.

A majority of the stem cells clinics isolate a mixture of cells which they call “stem cells”. Their “stem cells” are composed of a proportional mixture of differentiated cells, progenitor cells and stem cells from either bone marrow or adipose tissue in usually the same ratios as located in those tissues. They then give that mixture to the individual, either as a direct inject or systemically, with the hope that ‘something useful’ will occur.

In contrast to most stem cell clinics, Research Designs has committed itself to a more selective approach. Research Designs gives the patient a nutraceutical to increase the production of pluripotent stem cells and totipotent stem cells, making the person their own bioreactor. Prior to harvest we give the patient a second nutraceutical to cause extravasation of pluripotent stem cells and totipotent stem cells into the blood stream. We then harvest stem cells by a simple blood draw and then isolate, segregate, purify, and activate individual populations of stem cells, i.e., mesodermal stem cells, pluripotent stem cells, and totipotent stem cells.

For neurodegenerative diseases, and based on the inherent properties of the stem cells, we give purified totipotent stem cells via a relatively non-invasive route to bypass the blood-brain barrier and migrate to areas of damaged tissue within the CNS and repair the damage. We also give purified populations of pluripotent stem cells and mesodermal stem cells systemically to ensure that the stem cells stay where they have been delivered to enhance the resultant repair processes and provide nutritional support to the newly formed tissues.

While we, like others, have anecdotal accounts of success for AD, PD, MS, CIDP, Stroke, TBI, and ALS, we also have peer-reviewed published papers detailing a clinical trial of Parkinson disease utilizing these stem cells with a single transplant using the person’s own stem cells (autologous). By two months after the single stem cell transplant all individuals in the study (n=8) demonstrated quantitative benefits. At the 7-month and 14-month follow-ups, 25% (n=2) demonstrated a slower increased progression of symptoms of the disease, 50% (n=4) demonstrated a stability of symptoms, and 25% (n=2) demonstrated a loss of symptoms and return to normality.

While our procedures have not as yet been approved by the FDA for general commercialization, we are communicating with the FDA for potential approval. In the interim we have been approved by an oversight committee, termed an Institutional Review Board (that oversees patient care), to study the effects of multiple endogenous stem cell transplants for 60 individuals with neurodegenerative diseases.