Autologous Stem/Stromal Cells in Neurological Disorders and Disease
Autologous Stem/Stromal Cells in Neurological Disorders and Disease
The study deals with evaluation of safety and efficacy of use of stem/stromal cell isolates
 from autologous microvasculature in neurological, non-neoplastic disease. Autologous cells
 are acquired via microcannula aspiration of subdermal fat deposits, isolated through a
 digestive process, and concentrated via standard centrifugation. The cellular stromal
 vascular fraction (cSVF) created is neutralized and rinsed to eliminate residual enzymatic
 molecules.

 These cells are suspending in sterile Normal Saline Solution (500cc) and re-administered via
 an intravenous parenteral route, passed through a standard sterile 150 u (micron) filter in
 line.

 Multiple tracking and questionnaire followup is intended over a 5 year period, with objective
 and subjective criteria being met. Compilation and analysis of data to be completed after
 that period.
Dementia refers to neurodegenerative conditions causing gradual decrease in ability to think
 and recall, to the point that is impacts daily functions. It is often accompanied by language
 difficulties, wide ranging emotional issues, loss of language skills, and lowering of
 activity motivation. These changes are often in the face of unchanged consciousness.

 Most common type is Alzheimer's Disease (50-70% of cas.es), but include vascular dementia
 (25%), Lewy Body dementia (15%) and frontotemporal dementia. There are many interrelated
 disorders that mask the underlying issues, such as in Parkinson's Disease, and whose
 diagnosis may overlap with the others.

 Most common symptoms include memory lapses, visual-spatial language changes, attention loss
 and problem solving difficulties. A wide variety of other symptoms may be seen, such as
 balance issues, tremors, difficulty swallowing, hallucinations, wandering, restlessness or
 agitation/depression, mood swings, etc..

 Parkinson's Disease (PD) is a long-term neurodegenerative disorder of the Central Nervous
 System (CNS) that usually impacts the motor system, in a progressive and long-term fashion.
 Early signs include tremors, rigidity, slow movements and walking issues. It is often
 associated with thinking problems and depression, plus emotional states that impact daily
 living.

 The causation of PD is felt to involve genetic predisposition and environmental factors.
 History of head injuries, chemical exposures, smokers, caffeine intake and other dietary
 issues. The motor symptoms seem to result from cellular death in the midbrain area
 (particularly the substantia nigra) and associated with inadequate dopamine. Plaques (protein
 build up following cellular death) may be a prominent feature, and use of neuroimaging (like
 MRI with/without contrast) is of value to track progressive changes in the brain.

 Conventional therapy is use of L-DOPA and dopamine agonists and pharmaceutical agents have
 not proved of long-term reversal or arrest of the process. Evaluation of non-traditional
 methods are currently gaining popularity, especially in the area of stem/stromal cellular
 therapy.

 CNS Autoimmune Demyelination is group of disorders of the CNS which feature loss of myelin
 from unknown causes but include variants of encephalomyelitis, cerebral sclerosis of
 Schilder, multiple sclerosis, and idiopathic inflammatory demyelination.

 In cases involving myelin sheath of neurons is damaged, reducing the conduction of nerve
 signals causing loss of sensory, motor, cognitive abilities, and a wide variety of functions
 dependent on actual location of changes.

 There is strong evidence that autoimmune, infectious agents, and chemical reactions may
 contribute to the evolution of the disease complex. In cases of multiple sclerosis, it
 appears that T-cells and macrophages, and mast cells may be present in the CNS plaques that
 are characteristically seen in areas of the ventricles and scattered areas of the brain.
 These are typically identified and tracked by MRI studies.

 Traditional pharmaceutical approaches have proven to be of little advantage in reversing or
 completely stopping the disease processes. Many side effects and reactions, or loss of drug
 effectiveness have led researchers to explore use of stem/stromal cells with their effects on
 immunomodulation and inflammatory modulation effects. Early trials suggest that these may be
 able to actually reverse visible lesions and improve quality of function and life, with
 reported improvement in neurological conditions.

 Management of symptoms is often accompanied by lifestyle changes, rest periods, physical and
 mental rehabilitations, diet, chelation and hyper-vitamin infusions, and a number of
 antioxidant therapies. The progressive phases seem to include the innate immune system, and
 is felt to explain the potential value of use of autologous stem/stromal cellular groups,
 particularly involving the mesenchymal and pericytic/endothelial cellular groups.

 Sensorimotor demyelination neuropathies (HMSN) is group of neuropathies characterized by
 impact on afferent and efferent neural communications. They feature atypical neural
 development and degradation of nerve tissues.

 Two common forms of HMSN are either hypertrophic demyelinated nerves or atrophy of nerve
 (peripheral) and neural tissues. Hypertrophy is featured by neural stiffness rather than
 demyelination of peripheral nerves. Whereas atrophy causes loss of axons and neural cell
 bodies. They often experience progressive muscle atrophy and sensory neuropathy of the
 extremities. The term "hereditary motor and sensory neuropathy has been commonly referred to
 a forms of Charcot-Marie-Tooth Disease (CMT). There are distinct genetic and phenotypically
 distinct forms of CMT, and the term of HMSN is less frequently used.

 Usual onset is childhood or young adulthood, with motor involvement more prominent that
 sensory. Often mistaken for causalgia or fibromyalgia, the symptoms of fatigue, pain, balance
 loss, areflexia, visual changes, foot drop and scoliosis. As in the causalgia or Sympathetic
 Reflex Dystrophy (SRD), these patients are treated according to symptoms, with medication and
 traditional interventions proving of limited benefit. Some preliminary findings using the
 modulatory action of stem/stromal cells suggest some help with the symptomatology,
 particularly relative fatigue and pain.

 Huntington's Disease is an inherited disorder resulting in death of brain cells. A gradual
 change in mood or mental abilities, is followed by unsteady gait, jerky body movements,
 leading to speech loss or severe depression. Although associated with heredity or mutation,
 pharmaceuticals and stem/stromal cell therapy are felt to offer some assistance in
 maintaining quality of life (Qol).

 The huntington protein (HP) is poorly understood, but believe toxic to certain cell types,
 particularly in the brain. Damage is most noticed in the striatum of the brain. The changes
 associated with the HP relate to the cell transcription, cell signaling and intracellular
 transport.

 Most prominent changes are within the basal ganglia (neostriatum) and includes the caudate
 nucleus and putamen. Substantia nigra and cerebellum seem particularly impacted. Physical
 therapy, occupational therapy and speech therapy have been used in conjunction with trials
 using autologous stem/stromal cellular therapies are offering some slowing of the processes.

 Medications have been developed, but remain modestly effective and possessing major side
 effects and poorly tolerated. Most of the pharmaceutical approaches have not proven effective
 in reversal of the disease, many accepting a slowing or remission induction without inducing
 the body ability to provide any regenerative effects. Dietary controls, use of mind
 exercising, hyperoxygenation protocols, chelation, vitamin infusions, etc. have proven to be
 helpful adjunctive therapies. Alternative treatments, including physical therapy and some
 stem/stromal therapies have become more common.

 Three main characteristics of the neurodegenerative group are: 1). Lesion formations in the
 central nervous system (called Plaques); 2). Inflammation; 3). Demyelination and Destruction
 of myelin sheaths of neurons. This demyelination is thought to stimulate the inflammatory
 processes due to action of a lymphocyte group known at T-cell which seems to recognize
 patient's own myelin as foreign and proceeds to attack it (known as "autoreactive
 lymphocytes"). These findings are often concluded to represent an autoimmune response to
 one's own tissues. The inherent properties of modulation and inflammatory modulation make
 potential uses of autologous reparative group of cells located throughout the body in
 association with microcapillary structures in essentially every tissue in the body. These
 cells have been identified by cell surface markers and studied in tissue culture to have
 "multipotent" capabilities that potentially participate in the regenerative processes to help
 arrest or improve the autoimmune group of disorders.

 Traditionally, exacerbation's are often treated with high dose intravenous steroids which may
 be of short term reduction of symptoms, not addressing the underlying causation. Current
 medications available for treatment are expensive an fraught with major side effects, making
 their use very difficult and producing limited measured value.

 With the advent of convenient ability to acquire significant numbers of alive (viable) an
 easily gathered by harvesting from microvascular stores in the body (adipose tissue complex).
 Technological advances in sterile, closed processing, has provided the ability to easily and
 safely acquire significant of stem/stromal cells for use in clinical studies.

 This study is aimed at evaluation of the safety profile (adverse reactions & severe adverse
 reactions) of the closed syringe, microcannula harvesting of subdermal fat deposits (largest
 known source of microvascular tissues in the body). This autologous cell group obtained with
 isolation and concentration of cells within the stromal vascular fraction (SVF) via enzymatic
 digestion, and deployed via intravascular r rebral fluids in defects of the blood brain
 barrier (BBB) or are small enough to pass into the fluids of the CNS (central nervous
 system). Effects are believed to be a function of both cellular multipotent abilities, but
 also regards the autocrine/paracrine secretory capacity of the cell group within the body.
 The body has the ability to request (chemotaxis) certain needed cellular and secreted
 chemicals to help healing and regeneration. Current thought are trending that the secretions
 may, in fact, be more important to the reparative and regenerative processes than the
 cellular contributions.

 In this study, disorders which involve autoimmune and inflammatory changes that impact the
 brain and nervous system are to be study, tracked and reported over time to determine
 ultimate efficacy and the "interval" therapy needs (or lack thereof) to maintain the
 accomplished arrest or improvement in the underlying tissues. Currently these intervals are
 examined by brain magnetic resonance imaging (MRI) with and without contrast. Correlation of
 image changes and clinical function will be made with subjective Quality of Life (Qol) and
 diary type observations by patients and caregivers.
Inclusion Criteria:

 -  Documented Functional Neurological Damage To Central or Peripheral Nervous System
 Unlikely To Improve With Present Standard of Care Approaches

 -  At least 6 months after onset or diagnosis of disease process

 -  Current Medical therapy for the condition is either failing or not tolerated by
 patient

 -  Patient must be capable of interval neurologic exams with investigators or their own
 neurologic specialists

 -  Patient must be capable and determined competent to provide detailed informed consent
 for study participation

 -  In estimation of investigators, that there are minimal or no significant risk of harm
 to general health or conditions for collection of autologous stem cell collection and
 use

 Exclusion Criteria:

 -  Inability of patient to have diagnostic examinations or studies (MRI) to evaluate and
 document the disease state or unwilling/unable to cooperate with such documentation

 -  Patients not medically stable, or whom may have ongoing conditions which increases may
 place the patient at significant risk of major complications, to be determined by
 investigator or patient's medical provider or neurologic specialists

 -  History of active cancer or ongoing anticancer therapy within six months of such care

 -  Women of childbearing age must not be pregnant at the time of treatment, and should
 refrain from becoming pregnant of at minimum of 3 month after study treatment