Use of Cellular Stromal Vascular Fraction in Multiple Sclerosis,Autoimmune, Inflammatory, Neurologic Conditions

Multiple Sclerosis (MS) is a demyelination disease which features damage to insulating covers
of nerve cells in the brain and spinal cord. This damage or degenerative changes disrupts the
ability of parts of the nervous system to communicate, resulting in range of signs and
symptoms which include physical and mental changes.

Symptoms are variable and often include visual changes, sensory irregularities, and motor
coordination. MS has several forms which result in new symptoms in either isolated attacks
(relapsing forms) or gradual increasing symptoms (progressive forms).

While cause is not clear, mechanisms have been suggested association with loss of the immune
system or failure to produce myelin-producing cells. Some suggest a genetic predisposition or
environmental factor, but the exact causation in all cases have not been elucidated.

Medications have been developed, but remain modestly effective and possessing major side
effects and poorly tolerated. Alternative treatments, including physical therapy and some
stem/stromal therapies have become more common.

Three main characteristics of MS are: 1). Lesion formations in the central nervous system
(called Plaques); 2). Inflammation; 3). 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").

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 and fraught with major side effects, making
their use very difficult and producing limited measured value.

With the advent of convenient adipose harvesting and processing in closed systems, the
ability to easily and safely acquire significant of stem/stromal cells, studies are underway
to utilize autologous stem/stromal cells. This study is aimed at evaluation of the safety
profile (adverse reactions & severe adverse reaction) of the closed syringe, microcannula
harvesting of subdermal fat deposits. This autologous cell group obtained with isolation and
concentration of cells within the stromal vascular fraction (SVF) via enzymatic digestion,
and deployed via intravascular routes. As these cells are very small, there is belief that
they are able to pass into the cerebral fluids in defects of the blood brain barrier (BBB) or
are small enough to pass into the fluids of the CNS (central nervous system).

Inclusion Criteria:

- Documented functional damage to central or peripheral nervous system unlikely to
improve with present standard of care

- At least 6 months after onset of disease process

- If under current medical therapy (drug or surgical) for the condition, patient
considered stable on that treatment and unlikely to have significant reversal of
associated neurological functions damage as a result of ongoing treatments

- In estimation of providers and neurologists have the potential for improvement with
AD-cSVF treatment, and be at minimal risk of potential harm from the procedure

- Over 18 year old, and capable of providing informed consent

- Medically stable and cleared by primary care physician, neurologist, or licensed
practitioner that patient is felt to be reasonably expected to be expected to undergo
procedures without known significant risk to health

Exclusion Criteria:

- Patient must be capable of an adequate neurologic examination and evaluation to
document the pathology and ability to cooperate with examination

- Patient much be capable and willing to undergo follow up neurologic exams with
investigators or their own neurologists

- Patient must be capable and competent to provide informed consent to participation

- In estimation of investigators, the patient may be at increased or significant risk of
harm to the patient's general health or neurologic functions for collection of AD-cSVF
collection

- Patients not medically stable, or who may be at significant risk to their health
undergoing any and all procedures will not be eligible

- Women of childbearing age must not be pregnant at the time of treatment, and should
refrain from becoming pregnant for 3 months post-treatment