Multiple Sclerosis

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Multiple Sclerosis is known to affect women more than it affects men. Though the disorder is more common between the ages of 20 and 40, it is possible to see it at just about any age. The reason behind MS is known to be damage caused to the myelin sheath, which is the protective covering that surrounds nerve cells. As a result of this damage, nerve impulses slow own or stop comepletely.


As MS is a progressive disease, one can notice a worsening degeneration over time. The time frame within which this worsening happens often differs from one person to another.
It is imflammation that causes this nerve damage. Inflammation is often the result of the body’s own immunity cells attacking the body’s own nervous system. Having this ailment means that repeated swelling of such kind can occur along the brain or spinal cord area.
Though researchers are not completely sure as to what causes these inflammation episodes, most theroies point at genetic defects or viral attacks, if not both.
MS is more commony diagnosed in the northern and southern hemispheres, namely northern Europe, northern USA, New Zealand and southern Australia. These kind of geographic finding suggest that there may also be an environmental factor pertaining to the disease.
In conclusion one can say that people who have an MS familyhistory or those who live in the northern or southern geographical areas have a higher incidence rate or higher risk of getting this disease.

Symptoms

The symptoms of this ailment can vary simply because the location of the attack and its severity can differ from person to person. An episode of inflammation can last for several days or weeks or even months. MS is characterized by periods of no symptoms or reduced symptoms between episodes and these are known as remissions.
Having hot baths or exposure to the sun can trigger or worsen the attacks, just like fever and stress can. Relapses of the disease are also common. Even without the remissions th disease may continue to get worse. As the nerves of just about any part of the brain or spinal cord can be affected by this ailment, there is no one set of common symptoms for MS. Symptoms can be noticed at many perts of the body.
Some of the muscular symptoms include:

  • Spasms
  • Balance loss
  • Limb movement difficulties
  • Abnormal sensation or numbness in certain areas
  • Tremors
  • Weakness in the limbs
  • Diffculty in walking
  • Coordination problems

Some of the bladder and bowel symptoms are:

  • Stool leakage
  • Urination difficulties
  • Constipation
  • Frequent urges to urinate (often strong)
  • Incontinence

Some of the eye symptoms include:

  • Rapid and uncontrolled eye movements
  • Double vision
  • Vision loss often pertaining to one eye at a time
  • Eye discomfort

Numbness, pain or tingling may also be felt, along with

    • Tingling of the limbs along with burning feeling
    • Muscle spasms, which are painful
    • Facial pain

Other nerve and brain symptoms include:

  • Hearing loss
  • Balance problems and dizziness
  • Depression
  • Dificulty in resolving problems
  • Low attention span
  • Memory loss

Some common sexual symptoms include:

  • Erectile dysfunction
  • Dry vagina

Certain swallowing and speech related symptoms are:

  • Heavy slurring
  • Trouble swallowing and chewing
  • peech becoming difficult to understand

Additionally, as MS progresses, almost all patients complain of fatigue. It is especially noticeable in the late afternoons.
Test and Exams for Diagnosis
There are several other nervous system disorders that have the same symptoms as MS hence the disease must be diagnosed by ruling out these other ailments.
A form of MS known as relapsing-remitting requires that the patinet has had at least 2 attacks that are separated by a period of reduced or no symptoms for diagnosis.
If two different parts of the central nervous system have functional decreases at two distinctly different times, the health care provider may syspect it to be a case of MS.
Reduced nerve function in one areas of the body or over a whole spread may be seen in a neurological exam. Such a diagnosis may involve:

  • Decreased movement ability for that part
  • Decreased sensation at that part
  • Abnormal nerve reflexes in that area
  • Other nervous system function losses

Eye examinations could reveal the following:

  • Lowered visual acuity
  • Abnormal pupil responses
  • Rapid and uncontrolled eye movements, especially when the eyes move
  • Changes in eye movement or visual fields
  • Problems with the inside parts of the eyes

The doctor will run the following tests to confirm or refute an MS diagnosis:

  • Spinal tap test for studying the cerebrospinal fluid
  • Nerve function studies (evoked potential tests)
  • Brain MRI scans

Spinal MRI scans

DETAILS

When Should You Contact Your Health Care Professional?

Call your doctor under the following circumstances:

  • Visible or noticeable MS symptoms
  • Worsening symptoms, despite ongoing treatment
  • Home care is no longer possible

Alternative names
Demyelinating Disease or just MS
Kurtzke Disability Status Scale for MS
Scale 1: Minimal neurological symptoms and no disability
Scale 2: Mild visual disturbances, gait irregularity and stiffness or weakness, minimal disability
Scale 3: Monparesis or partial paralysis one part or just a part of one extremity, hemiparesis (paralysis of one side of the body), sensory loss, symptoms related to the urinary tract or eyes, ataxia and several lesser dysfunctions.
Scale 4: Though the disability is severe, patient is fully ambulatory and self sufficient with aid. The patient is normal for about 12 hours of a day and can work as well as caryy out normal activities. Sexual dysfunction could be a problem.
Scale 5: Severe disability that hampers work and the maximum that a patient can walk unaided is for about 500 m.
Scale 6: Patient now needs assistance while walking, in the form of crutches, canes, braces, etc.
Scale 7: Though patient is restricted to his wheelchair, he is able to wheel around by himself and can even enter or leave the wheechair without assistance.
Scale 8: Though patient still has effective use of his arms and can care for his own functions, he is essentially restricted to a chair or bed.
Scale 9: Patient is completely bedridden and helpless.
Scale 10: MS related death due to respiratory paralysis, repeated or prolonged epileptic seizures and coma of uncertain origin.

Regenerative Tissue Therapy (cells) for MS
Given below is a broad picture pertaining to the inclusion, exclusion and eligibility criterias. There are however some exceptions to these guidelines and such exceptions are appropriately deliberated upon for the final decision regardin the selection of any patient. Such a decision is solely in the hands of the project director and is usually determined after studying each case.
As far as preferences go, strong cases for the advocacy of the use of umbilical cord and vord blood derived Regenerative Tissue Therapy (cells) can be made over other autologous Regenerative Tissue Therapy (cells) that are dervied from other sources such as skin, bone marrow, peripheral blood, adipose tissue, small intestine, cornea (limbus), liver, etc. Still, the final decision regarding this judgement is also decided on a case to case basis after a detailed study and comprehensive deliberation of all the parameters including the patient’s medical history if done.
It is also strongly recommended that the GM-CSF therapy be undertaken before the Regenerative Tissue Therapy (cells) procedure as it helps to mobilise the patinet’s autologous cells from the bne marrow and urges them to act synergystically with the bone marrow that is later transfused. This helps in bringing out optimal results from the entire Regenerative Tissue Therapy (cells) procedure.
Additional supporting therapies such as the two listed below are also recommended by the project director:

Hyperbaric Oxygen Therapy
In this therapy, the patient is taken to special hyperbaric oxygen chambers and administered with hyperbaric oxygen. The outcome of this treatment is the decompression sickness (air embolism) is effectively treated, the partial pressure of oxygen within any damaged tissues in the body is increased and the blood’s oxygen carrying capacity in the patient’s body is significantly pushed up.

Chelation Therapy
The objective of this therapy is to remove toxic heavy metals such as mercury, arsenic, uranium, plutonium, lead and iron (including in thalassemia cases) from the patinet’s body. The agent responsible for this chelation is either administered orally, intramuscularly or intravenously and this decision depends on the type of poisoning to be treated as well as the agent that is being used.
Though there are several chelating agents available, the choice depends on the poisoning that needs to be treated as different agents have different metal affinities. Some of the more common agents are listed below:

  • BAPTA or Aminophenoxythane-tetraacetic acid
  • ALA or Alpha lipoic acid
  • Deferiprone
  • Deferasirox
  • DTPA or diethylene triamine pentaacetic acid
  • Deferoxamine
  • BAL or Dimercaprol
  • DMSA or Dimercaptosuccinic acid
  • DMPS or Dimercapto-propane sulphonate
  • D-penicillamine
  • EGTA or Ethylene gycol tetraacetic acid
  • (CaNa2-EDTA) or Ethylenediamine tetraacetic acid

Before starting any Regenerative Tissue Therapy (cells) procedure, the project director strongly recommends that each patient undertake both the hyperbaric oxygen therapy as well as the chelation therapy. After these therapies the infused Regenerative Tissue Therapy (cells) find it easier to be accepted and engrafted into the damaged tissues or organs and can thus begin a swift repair process. Though this too is determined on a case to case basis, undertaking these two therapies before Regenerative Tissue Therapy (cells) procedures ensures that the Regenerative Tissue Therapy (cells) procedure results are optimized.

Eligibility Criteria

  • People within the ages of 18 to 55 years are eligible for the study.
  • Both genders are welcome into the study.
  • Healthy volunteers are not accepted into the study programs.
  • Any and all races and ethnicities are welcomed into the study.

Inclusion Criteria

  • Inclusive ages between 18 and 55
  • Using McDonald criteria of clinically definite MS, diagnosis of MS should be confirmed.
  • Any MS patient who falls on scale 5 or beyond of the Kurtzke’s scale.
  • Inflammatory disease despite standard disease modifying treatments including at least 6 months of interferon or copaxone use. The inflammtory disease is defined on the basis of both an MRI (showing gadolinium enhancing lesions) and clinical activity (showing actute relapses despite treatment with high IV doses of corticosteroids). The minimum disease activity for determining such failure should be (a) two or more relapses within 1 year of study, with documented neurological changes (b) one steroid clinical relapse within 1 year before the study along with MRI evidence of active inflammation within the last 1 year on an occasion that is separate from the lcinical relapse (usually 3 months before or after the clinical relapse). Such as steroid treated relapse includes relapses that were severe enough to justify treatment but due to the patient’s intolerance of steroids, or a history of steroid non-response, they were not used in the treatment.

Exlcusion Criteria

Any illness that could lower the patient’s tolerance of aggressive chemotherapies.

Previous therapies with mitoxantrone.

Previous malignant tumor history, except for localised basal cell carcinoma, carcinoma in situ of the cervix and squamous skin cancer. If the patient has been cured of malignancies such as head, neck and breast cancers, he or she will be considered on the merits of his or her particular case.

Pregnancy test positive.

Unwillingness or inability to take effective birth control measures, which can e defined as (a)total abstinence (b) consistent birth control pills intake (c) injectable birth control (d) tubal sterilization or vasectomy (e) placement of an intrauterine device (f) use of condoms with contraceptive foam or ceontraceptive jelly.

Failure to understand the implictions or of willingly accepting the likelihood of irreversible sterility as a therapy side effect.

Even after bronchodilator therapy, FEV1/FVC is less than 60 percent.

DLCO is less than 50 percent of the predicted value for the transplant arm.

Resting LVEF is less than 50 percent.

Bilirubin amount is more than 3mg/dl.

Serun creatinine amount is more than 2mg/dl.

If the patient is known to be hypersensitive toways iron medications or compounds or even to mouse, E. Coli and rabbit derived proteins.

Presence of any metallic objects in the body that can prevent the undertaking of safe MRI exams.

If the patinet is diagnosed with primary progressive MS.

If the patinet is diagnosed with secondary progressive MS.

Bllod reports show platelet count of less than 50000/ul and white blood cell count of less than 1500 cells/mm3.
Any active infections other than asymptomatic bacteriuria.

Natalizumab use within the last 6 months
Diagnosis of any mental deficiency, psychiatric illness or cognitive dysfunction that may mke informed consent and compliance impossible.

How It Works

Basic Overview

Prior to Regenerative Tissue Therapy (cells) infusions, especially in the case of frozen Regenerative Tissue Therapy (cells), the following basic principles need to be followed:

Using a warm water bath at 37 degrees celcium, the frozen Regenerative Tissue Therapy (cells) should first be thawed by constant agitation.

Exposure to any form of bright lights should be prevented at the time of thawing.

The syringe used for Regenerative Tissue Therapy (cells) collection should be covered with tape so as to prevent light exposre during collection and transfer. Collection should be done using a wide (18 number) bore needle, so at to prevent the delicate Regenerative Tissue Therapy (cells) from being damaged.

Infusions should be made in dim light using a 23 gauge needle. These need to be undertaken over a period of 3 to 5 minutes.
Immediate transfusion reactions can occur after such as administration and these need to be checked for.

Administration Mode and Dose:

Those the Regenerative Tissue Therapy (cells) doses vary from case to case, they usually range between 30 to 100 million Regenerative Tissue Therapy (cells) in order to generate adequate results. Sometimes, even doses as low as 1 million has displayed adequate positive outcomes.

We mostly recommend intraveous administration of Regenerative Tissue Therapy (cells) in most cases; but while treating certain specific conditions intramuscular, intraarterial, subcutanous, sub-dural, intrathecal, suc-arachnoid and intraocular administration may be warranted. Sometimes, even direct administration of the Regenerative Tissue Therapy (cells) at the site of exact injury through procedures such as direct injection or implanatation using special interventional techniques may also be suggested.

The final dose and administration mode decisions are best taken after the case has been throughly studied and deliberated upon.

Treatment Details

Allogenic Umbilical Cord Derived

One day before each umbilical Regenerative Tissue Therapy (cells) dose infusion should be preceded with a GM-CSF dose. This should be done in a dose of 5 microgram per kg body weight in adults and 2.5 microgram per kg body weight in children.

Mode of administration of GM-CSF:

The usual mode of administration is an a subcutaneous (under the skin) injection but GM-CSF may also be given as an intravenous infusion.

Side Effects of GM-CSF

The following are the main points pertaining to the GM-CSF dose:

Not all of the side effects listed for the treatment are experienced by all the people who go through with it.

Not only are the side effects predictable in their duration and onset, but also they are almost always reversible and often go away after the treatment is complete.

Patients have several options that can help them prevent or minimize the side effects of this dose.

Just because your side effects are present or severe it does not imply that the medication is effective.

Commonly Experienced Side Effects of GM-CSF:

As the first dose is administered, the person may feel what is known as the first dose effect. This side effect does not happen with any subsequent doses and usually involves low blood pressure, lightheadedness, flushing and feeling faint.

Other side effects are diarrhea.

With the first dose of GM-CSF, a person may experience low blood pressure, fast heart rate, flushing, lightheadedness or feeling faint. This is referred to as “first-dose effect,” and tends not to happen with future doses

Diarrhea, localized reactions such as redness, swelling and tenderness at the injection site, and fatigue and weakness.

Less Common GM-CSF Side Effects:

Along with swelling in the hands and feet, people may experience mild flu-like symptoms such as headaches, generalized aches and pains, fatigue, weakness and fever.

Additional points to remember in case of using umbilical cord lining or cord blood Regenerative Tissue Therapy (cells):

The CD 34+ cells that are puported in this discussion ate the cells that are similar to the hematopoetic cells that carry the CD 34+ markers. The CD 34+ markers are obtained after isolating cells from the cord blood using cell sorting techniques and magnetic beads.

The Mesenchymal Regenerative Tissue Therapy (cells) that are purported in this discussion are the cells similar to the total nucleated cells that are derived after exhaustive processes from the cord lining.

Regenerative Tissue Therapy (cells) Dose

32 to 80 million Mesenchymal Regenerative Tissue Therapy (cells) along with 10 to 40 million CD 34+ cells over a 1 year period.

Duration: Over a period of 3 months (concurrently with GM-CSF therapy one day before the Regenerative Tissue Therapy (cells) infusion), 8 to 20 million mesenchymal Regenerative Tissue Therapy (cells) plus 2.5 to 10 million CD 34+ cells.

The total dose of Regenerative Tissue Therapy (cells) approximately totals to 100 to 200 million for generating an adequately favorable response.

Mode of Administration

Intravenous administration is advocated.

Possible Regenerative Tissue Therapy (cells) Side Effects:

Rash

Fever

Headache

Quality Checks:

Quality of the Regenerative Tissue Therapy (cells) should be checked with the following tests under GMP and GLP standards:

Endotoxin content tests
Bacterial contamintion tests
CMV tests
HbsAG tests (ELIZA and PCR)
HCV tests (ELIZA and PCR)
HIV I and HIV II tests (ELIZA and PCR)

Or

Autologous Bone Marrow Derived Regenerative Tissue Therapy (cells)

With aseptic precautions and under general anesthesia in an OT, 150 to 200 ml of bone marrow is collected in a blood bag.
Under GMP and GLP stanrads, Regenerative Tissue Therapy (cells) are then isolated and processed.
When a final volume of about 5 to 10 ml is collected, it is intravenously administred within 6 to 8 hours of its collection.
Antibiotic cover is administered prior to this infusion as the Regenerative Tissue Therapy (cells) cannot be checked for bacterial contamination.

Mode of Administration of Regenerative Tissue Therapy (cells)

Intravenous administration is advocated.

Or

Autologous Regenerative Tissue Therapy (cells) Derived from Adipose Tissue

Using liposuction, about 150 to 200 ml of adipose tissue is collected in a blood bag. This is done by a trained plastic surgeon and in an OT under the effects of general anesthesia.
Under GMP and GLP standards then, Regenerative Tissue Therapy (cells) are isolated and processed to reach a final volume of 5 to 10ml. This is then administered intravenously, within 6 to 8 hours of its collection.
Antiobiotic cover is often warranted as the infused Regenerative Tissue Therapy (cells) cannot be checked for bacterial contamination.

Mode of administration:

Intravenous administration is advocated.

Or

Autologous Regenerative Tissue Therapy (cells) Derived from Peripheral Blood

Using a procedure called ‘apheresis’, which is carried out in an ambient environment, Regenerative Tissue Therapy (cells) are collected.
Then, using well programmed cell separators such as Kobe Spectra or Homonitics, the desired 200 to 250 ml of Regenerative Tissue Therapy (cells) are isolated in a specially designed blood bag.
GM-CSF is administed in 5 microgram dose per kg body weight in adults and 2.5 icrogram per kg body weight in kids, before th infusion. This ensures that there is maximum mobilization of the Regenerative Tissue Therapy (cells) from te bone marrow.
Mode of administration:

On again, intravenous administration is preferred.

Or

Autologous Regenerative Tissue Therapy (cells) isolated from skin, cornea, teeth, small intestine, liver etc.

Sophisticated techniques are required to procure Regenerative Tissue Therapy (cells) from any of these organs and these procedures are performed under general anesthesia and in an OT.
Then, under GMP and GLP standards, adequate volumes of about 5 to 10 ml Regenerative Tissue Therapy (cells) are processes and isolated.
These are then administered intravenously within 6 to 8 hours of their collection.
As there is no way to check for bacterial contamination of these Regenerative Tissue Therapy (cells) before infusion, antibiotic cover is advocated.

Mode of administration:

Intravenous is the normal mode of infusion.

Follow Up Requirement

After the first dose, follow ups may be required every 2 months.

OR

Autologous / Allogenic therapy using Regenerative Tissue Therapy (cells) from placenta, amniotic sac and / or amniotic fluid

Progentitor cell populations of really diverse varieties, including trophoblastic, hematopoetic and mesenchymal cells along with some more primitive Regenerative Tissue Therapy (cells) can be isolated from the placenta and amniotic fluid. As at least some of the cells from these two share common origins in the form of the inner cell mass of the morula and hence they share many characteristics with each other. Both these sources contain multiple progenitor type of cells, which come from the developing embryo and include fat, bone and muscle.

Placenta and Amniotic Sac (amniotic membranes):

After a simultaneous harvest of blood cells from the placenta tissue (UPT), placenta blood (UPB) and umbilical cord (UCB) for their content of nucleated cells CD 34+, results reveal that the nuclear cells (NC) from UPT and UPB are 3 to 4 times greater than those from UCB only.

Additionally cells from these two courses have higher survival capabilities than the cells from UCB, especially in long term cell cultures. When these cells are stored in liquid nitrogen, they do not displat large losses of total nucleated cell count and CD 34+. Additionally, as they contain more number of suppressor lymphocytes, they may also be able to prevent graft versus host disease.

All of thes eimpications together suggest that placental blood and tissue collection and processing together with UCB for Regenerative Tissue Therapy (cells) transplantation is very important.

Amniotic Fluid

Amniotic fluid derived Regenerative Tissue Therapy (cells) have been used to differentiate into several things, such as cartilage, muscle, adipose tissue, blood vessels, bones, nerves, etc. These are thus a valuable source of Regenerative Tissue Therapy (cells) for tissue, organ and cell repair.

AFS or Amniotic Fluid Derived Regenerative Tissue Therapy (cells) could be an intermediate stage between adult cells and embryonic cells. These cells are incredibly capable of extensive cell renewal and can also be used to produce a diverse range of cells that may be valuable for different therapies.

AFS cells are found aplenty in the amniotic fluid, which can be easily procured through a procedure known as amniocentesis. This is a general procedure also used to examine cells for genetic disorders in babies as part of prenatal diagnostic procedures. As these cells are primitive in nature, the possibility of perfect matches is very high with them.

Following are some of the main advantages of AFS cells:

Amniocentesis makes them easily obtainable.
These cells double every 36 hours, making them a very useful resource for growing large quantities of Regenerative Tissue Therapy (cells).
No feeders or factors are required to direct these cells towards any desired cell line.
These cells do not cause tumors and are hence preferred over other types that can.
AFS cells consist of all 3 different types of cells that are found in embryos, namely ectoderm, endoderm and mesoderm, thus making these cells capable of differentiating into any of the body’s cells, organs or tissues. Just like embryonic cells, AFS cells can generate every possible type of adult cell.
Hence, the project director prefers and advocates the used of Regenerative Tissue Therapy (cells) from the amniotic sac, amniotic fluid and placenta. In a clean room and under GMP and GLP standards, these cells are carefully isolated and processed. These cells may then either be used for allogenic or autologous use just like the Regenerative Tissue Therapy (cells) isolated from cord tissue and blood, along with other concurrent therapies such as chelation therapy and / or hyperbaric oxygen therapy. Depending on the case, the project director chooses the Regenerative Tissue Therapy (cells) to be used, their dosage quantity, adjacent therapies and route and mode of administration.

Mode of Administration of Regenerative Tissue Therapy (cells)

Intravenous administration is usually advocated.

Known Possible Side Effects of Amniotic Regenerative Tissue Therapy (cells)

Similar to any other Regenerative Tissue Therapy (cells), people may experience side effects such as mild fever, headache and rashes.

Quality Check

Quality of the Regenerative Tissue Therapy (cells) should be checked under GMP and GLP standards using the following tests:

Endotoxin content tests
Bacterial contamintion tests
CMV tests
HbsAG tests (ELIZA and PCR)
HCV tests (ELIZA and PCR)
HIV I and HIV II tests (ELIZA and PCR)

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