Glaucoma

Glaucoma treatment

with autologous stem cells from your

own bone marrow.

Information for patients

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Health People

What is Glaucoma?

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Glaucoma is a group of diseases of the optic nerve involving loss of retinal ganglion cells in a characte-ristic pattern of optic neuropathy. Although raised intraocular pressure is a significant risk factor for developing glaucoma, there is no set threshold for intraocular pressure that causes glaucoma. One person may develop nerve damage at a relatively low pressure, while another person may have high eye pressure for years and yet never develop damage. Untreated glaucoma leads to permanent damage of the optic nerve and result-ant visual field loss, which can progress to blindness.

Glaucoma has been nicknamed the “sneaky thief of sight” because the loss of visual field often occurs gradu-ally over a long time and may only be recognized when it is already quite advanced. Once lost, this damaged visual field could rarely be repare with great difficulty be recovered. World-wide, it is the second leading cause of blindness. Glaucoma affects one in two hundred people aged fifty and younger, and one in ten over the age of eighty.

Symptoms

At first, there could be no clear symptoms. Vision stays normal, and there is no pain.

But, after performing computerelectronic visual field, and Macular Threshold Field the ophthalmo-logist can detect the first signs of retina activity degeneration.

As the disease progresses, a person with glaucoma may notice his or her side vision gradually failing. That is, objects in front may still be seen clearly, but objects to the side may be missed.As glaucoma remains untreated, people may miss objects to the side and out of the corner of their eye. Without treatment, people with glaucoma will slowly lose their peripheral (side) vision. They seem to be looking through a tunnel. Over time, straight-ahead vision may decrease until no vision remains. Glaucoma can develop in one or both eyes.

Diagnosis

Glaucoma is detected through a comprehensive eye exam that includes:

- Visual field test. This test measures your side (peripheral) vision. It helps your eye care professio- nal tell if you have lost side vision, a sign of glau- coma

- Dilated eye exam. Drops are placed in your eyesto widen, or dilate, the pupils. Your eye care profes sional uses a special magnifying lens to examine your retina and optic nerve for signs of damage and other eye problems. After the exam, your close-up vision may remain blurred for several hours.

- Tonometry. An instrument (right) measures the pressure inside the eye. Numbing drops may be applied to your eye for this test.OCT, retinal exami- nation map can give you the exact pachy-metry of the diffe-rent layers of the retina, particularly the macula.

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About Stem Cells

The discovery of the stem cell has lead to a revolution in modern medicine. Stem cells are in fact, the “smart cells” of our bodies. These cells migrate to injured areas within the body and transform themselves into new tissue cells that replace the damaged ones. The body repairs itself by continuously producing new cells and tissues in this manner.

Stem cells have the capacity to multiply and to renew themselves almost indefinitely. This contrasts with nerve cells, muscle cells and blood cells, which cannot multiply themselves and have limited life spans. Stem cells can also develop into specialized cells.

The Cells4health Glaucoma treatment

The entire procedure consists of the following phases: eligibility, stem cell collection and processing, stem cell treatment, and follow up.

Objectives

The expected effect on Glaucoma from stem cells implanted behind the posterior pole of the eye is the capacity to able to repair the cribriform plate, the atony of which is seen today as a primary cause of the progres-sive and irreversible aggravation of a Glaucoma affected eye that has been cured too late. The above will finally lead to an improved individual vision.

Another possibility lies in the intracanalicular use (canal of Schlemm) of these stem cells to improve the hydro-resistance of the corneoscleral trabecu-lar, permitting and improving the flow of the aqueous humor.

Liver

Brain

Blood cell

Cardiac muscle

Adult Stem Cell

Skeletal muscle

Bone marrow

Epithelial cell

Neuron

Stem Cell

Specialized Cell(e.g., neuron)

Stem Celle.g., hematopoietic stem cell

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Preparation Application of local anesthetic

Disinfection of the collection site Needle insertion into the hip bone Sample collection

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Eligibility phase

If you meet the following conditions, you are eligible for treatment:

- Glaucoma diagnosed from your ophthalmologist possibly supported by coherence tomography (OCT), scanning laser polarimetry, and/or scanning laser ophthalmoscopy and/or Heidelberg Retina Tomogra phy and/or Goldmann tonometry

- Our medical team approves your specific case for treatment

- Your bone marrow contains a sufficient quantity of viable stem cells. This is assessed during the processing phase.

(iliac crest)

Bone Marrow

Collection

Procedure

These pictures show the Bone Marrow Collection Procedure

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Stem Cell Collection and Processing

Prior to scheduling bone marrow collection, you will be asked to fill out the patient consent form. This form grants explicit written permission for bone marrow collection. You must discontinue using any blood diluting medications at least 10 days before your collection date. You should consult your physician before discontinuing the use of blood diluting drugs.

When we greet you on the collection day, we’ll have everything prepared to begin collection and make it comfortable for you. Our physician will collect approxi-mately 150 – 200 ml of bone marrow from your hip bone. Stem cell collection is performed as an out-patient procedure under local anesthesia in sterile conditions. It is comparable in pain to a dentist visit.

During the collection, you will barely feel the needle insertion into your hip bone.Afterwards, the collection site might look like a “blue spot” and be a bit painful for 3 – 4 days.

Normally, there are no other side-effects. Theoreti-cally, there is a small risk of infection. We minimize this risk by working in a sterile environment.

Within 24 hours, the stem cell samples are processed and quality tested by a highly specialized laboratory in totally sterile, clean room conditions. Since they are kept in sterile tubes and never come into contact with the air, these samples cannot be contaminated.

Bone marrow processing and quality testing consists of:

- Stem cell isolation – stem cells are separated from the red blood cells and blood plasma.

- Stem cell counting

- Stem cell vitality measurement

- Stem cell processing results are documented in an analysis report.

The result is positive if:

- There are more than two million (2,000,000) CD34+ stem cells present.

- The CD34+ stem cells have a vitality greater than 80%

- Positive isolated stem cell samples are stored in sterile tubes at -196°C in liquid nitrogen.

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Stem Cell Implantation

Your high-quality stem cell sample will be implanted behind/or into the eye depending to the different stage of the disease, under local anesthesia per injection or via eye drops.

Possible Adverse Events from the treatment

Patient may experience intense red eye caused by the subconjunctival introduction of stem cells fluid that naturally contains a small amount of blood cells. This increases eye stimulation and is known in medicine as “self-blood-therapy” (auto-emoterapia).

The eye will become normal in 3 – 5 weeks maximum. In very rare instances, this stem cell fluid can migrate down under the eyelid and cause bruising.

There is no cause for alarm when “red eye” or eyelid bruising occurs. The body will naturally absorb this excess blood. Actually, this excess blood serves to better stimulate the eye.

Note: If your bone marrow sample is negative or the stem cells cannot be administered due to unforeseenmedical circumstances, you will only be required to pay charges incurred to that point. In the case of a negative bone marrow sample, it might be possible to schedule another bone marrow collection.

Treatment Advantages

- Simple- Out patient- Low overall risk- risk-nearly absent

Follow-up

Once you have returned home, a member of our medi-cal team will regularly monitor your progress via telephone and email. For your convenience, a telephone “hotline” is always at your disposal.

General

No additional charges will be incurred unless you are required to extent your stay at the medical center as a result of complications. Costs do not include additional stem cell treatments. If another treatment is neces-sary, we will discuss potential options with you.You will receive an invoice one week prior to treatment. This invoice must be paid in-full before treatment can begin.

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