onsdag 9 oktober 2019

Stem Cell Expansion and treatment of Secondary Atrophic Rhinitis with the clinic Ilaya

Back at 2014 I visited the "fantastic" Swedish healthcare system due to Rhinitis witch is simply a stuffy nose. No allergy or food intolerance test were taken and instead the Swedish surgeon Anders Arnbrandt suggested a surgery to fix what he called a deviated septum. After this surgery my life turned down and I now experience daily suffering with: Dry nose, nose and eye nerve pain and Atrophic Rhinitis which is a condition when the nasal mucosa degenerates. Also I’m not capable to be in any kind of environment where there is warm, cold or dry air since this cause tremendous pain and discomfort. Up on that I lost sensation of breathing in my right nostril since nerves and thermoreceptors are damaged with cause pretty much of a stress response to deal with.

After having this problem for many years I decided in April 2019 to get an x-ray to see what the nose post-surgery looks like. This is when the shocking news came to me. The swedish surgeon Anders didn’t just operated at the septum but did also cut 50-60 % of the original length of my inferior turbinate’s without telling me about it. He used a chirurgical scissor to cut of the anterior heads of the turbinate’s plus all bone and tissue 3-4 cm inwards. This has left me with an over opened nose mutilated from the tissue that should produce mucus to cherish the mucosa.

The over opened nose causes me to get to much air to fast (hyperventilation) and the air that’s inhaled will not get humidified or filtered. This causes dry air hitting the back of the nose causing a lot of pain and discomfort. Since there is little remaining tissue to swell and de swell I also completely lost the nasal cycle in the right nostril, Its now always wide open. Also since most of the active immune cells are located in the anterior part of the inferior turbinate’s the immune function in the nose is badly damaged witch cause recurrent infections.

I’m now left butchered and the Swedish healthcare system won’t do anything about it. I’m now scheduled to get a regenerative cartilage implant surgery in Italy with Professor Fabio Piazza to try to restore some of the damage Anders left me with. Unfortunately I can never get a 100% functional nose again since I’m so butchered. Most functional tissue of my inferior turbinate’s is now copped of and some cartilage can never replace a complex organ with many functions. Of course the Swedish healthcare system don’t take any responsibility for this and even dough the original surgery was done for free I now have to pay a huge amount of my own money to try to restore what they destroyed.

Ilaya. What I’m now going to do except to get cartilage implants in the nose is to try to restore the damage I had from the surgery and from the following dryness with injections of expanded stem cells. I have now contacted a Ukrainian stem cell clinic (https://ilaya.com/) to gather information and this will be presented in this article. The reason that I’m choosing a Ukrainian clinic is that’s its forbidden in EU and US to use expanded stem cells except in science studies. 

So what I’m going to do is to leave a piece of skin to Ilaya and wait about 4 weeks for the clinic to expand them. After that I will visit the clinic again to get injections done in the nose. Hopfully this injections can help a little to resore some of my damaged nasal mucosa.

All questions to and answers from the clinic will be presented here and I’m going to do ongoing updates in this article as new info comes to me. Also if a really choose to go with this option all my experience will be shared here for other people to get help from. Note that I got the diagnose Secondary Atrophic Rhinitis or Empty nose syndrome and all my questions to the clinic have as a goal to try to find out the best possible treatment option for this condition.

Questions to Ilaya 2019-10-02

Do you offer Cryopreservation of my own stem cells? How much does that cost?
That's right, But we call it bioinsurance because we do not only offer to freeze it, but also to isolate it from your tissues, create a master bank, and multiply according to your desire. Bioinsurance is the creation of a reserve of body cells (banking), which can be used to treat many diseases, as well as preserve youth on long years. For realizing we use stem cells which, during use, turn into the necessary cells of many organs of our body.

This feature of stem cells opens up wide prospects for their use for medical purposes with:

Restoring bone and cartilage;

Neurological diseases - stroke, injuries to the spinal cord and brain;

Burns & skin deffects

Pathological changes in the myocardium;

Type II diabetes mellitus;

Pathology of the liver - cirrhosis, hepatitis;

Multiple sclerosis;

Alzheimer’s disease;

Thyroid disease;

And many others.

Not everyone can have bioinsurance. It is forbidden to work with infected material, so patients with HIV, hepatitis or syphilis will not be able to get their own stem cells, for example.

To start, the patient must be tested to get bioinsurance. Next, a painless (under local anesthesia) punch biopsy is taken from the scalp of the patient in the cervical region.

In ilaya, we distinguish 3 types of cells: dermal fibroblasts, mesenchymal stem cells and stem cells - derivatives of the neural crest. This is the advantage of ilaya, as usually a separate biopsy is performed for each type of stem cell. The most common is lipoasperation, which is more traumatic. Also, the ability to cultivate the Neural Crest-Derived MSCs (Multipotent mesenchymal stem cells – neural crest-derived (NC-MSC), cultured, autologous – a cell product derived from human hair follicles, isolated, identified and cultivated on a medium with growing factors. Cells have the ability to differentiate and proliferate. It is stored in frozen form in dewars with nitrogen). It is our pride.

After all, the patient's own stem cells are processed to form an individual master bank of 5 million cells of each type, which is stored at extremely low temperatures for many years.

Using a master bank, you can expansion any dose of 1 or 10,000,000 million stem cells at any time.

Each stem cell product and master bank has an individual passport that meets international standards.

If a patient needs to use his stem cells, the necessary therapeutic dose of cells from an individual master bank is cultivated.

All bio deposits are stored in our own cryobank at extremely low temperatures. Each bio-sample has its own personal storage plan.

Each product has its own individual passport stem cell product.

The advantage of ilaya is that we not only banking/save stem cells, but also we have real experience in using it in medical practice.

The price of bioinsurance depends on the number of types of own stem cells that the patient wants to save. The most expensive part of the bio-insurance procedure is the creation of a master bank for each type of stem cell. The price starts at 1500 euros for 1 type of stem cell. Saving for years is paid separately.

Do you charge anything when I want to use my cells in the future?
If, how much?

A Master Bank cannot be used for treatment. So each time the patient wants to receive treatment or rejuvenation, the doctor determine a dose of stem cells, which is additionally “expansionn” by biotechnologists. So yes - every time the patient wants to use own stem cells, it must payted for the therapeutic dose was given.

Using a master bank, patient can have any dose of stem cells at any time during all life.
An alternative is to immediately “expansioning” a some dose of own stem cells and freeze it immediately with a master bank.

The cost of each subsequent therapeutic dose depends on the size of the dose. Usually, for intranasal injections for treatment course of diagnosis empty nose syndrome or chronic rhinitis, doses of 10 to 40 million are used. According to actual price list it costs from 480 to 2500 euros (according to the current rate).

How long can the cells be stored for?

cells like a master-bank or therapeutic dose can be stored for an unlimited period of time observing storage conditions. The usual is storage in a cryobank in a special boxing in liquid nitrogen at a temperature of -184 degrees.

Will the cells stay 100% healthy and in good shape during the whole storage time or will they somehow decline?

Yes, the stem cells will stay 100% healthy and in good shape during the whole storage. Stem cells doesn't somehow decline during the storage time.

How and where will you store the cells?

We will store stem cells in our own cryobank ilaya. The storage in a cryobank in a special boxing in liquid nitrogen at a temperature of -184 degrees.

What happens during loss of electricity? Do you have any backup generators?

Yes, we have backup generators. The pretense of reserve generators is a mandatory part of obtaining a license for the legal activities of cryobanks in Ukraine and around the world.

I’m sorry about the situation between Russia and Ukraine, what can you possibly do to protect the lab and the cryopreservation of my cells from future consequences of the conflict? Where is the lab situated? West or east part?

Please do not worry about it. All our facilities including cryobank are located in Kiev, the capital of Ukraine. This is more than 1000 km from the venue of the ATO. Kiev is completely safe. It regularly have international events here.

From what kind of tissue do you extract the stem cells? Adipose tissue, blood, bone marrow?

We can extract stem cells from any human tissue. We prefer minimally invasive methods.

For example, from an behind-the-ear punch biopsy, we can extract 3 types of SC rhinestone tissue, instead of doing 2 biopsies and lipoaspiration.
It should be understood that, for example, bone marrow cells can be extracted only from bone marrow.

We extract the mesenchymal stem cells of the Neural Crest-Derived MSCs and MSCs from adipose tissue from the behind-the-ear punch (receiving a hair follicle and 2 mm of skin around it).

How long time does the expansion of the cells take?
And how much does that cost?

The expansion of the stem cells takes about 4 weeks after biopsy. The period depends on the required dose of stem cells.

The cost of each therapeutic dose depends on the size of the dose. Usually, for intranasal injections for treatment course of diagnosis empty nose syndrome or chronic rhinitis, doses of 10 to 40 million are used. According to actual price list it costs from 480 to 2500 euros (according to the current rate). It is the price of a dose of stem cells without the cost of diagnosis and/or medical services.

The price of Bioinsurence starts at 1500 euros for 1 type of stem cell. Saving for years is paid separately.

What are you doing to avoid contamination of the expanded stem cells? Ex with fungus or with bacteria? How can you make sure that my sells during expansion does not expansion uncontrolled so that they later on will cause cancer or other problems?

There is no documented case of this anywhere in the medical literature, and thus no basis for this opinion; stem cells are no more likely to cause cancer than any other therapy.

Treatments such as ilaya’s are based on adult mesenchymal stem cells. Mesenchymal stem cells are defined cells. These cells belong to a designated type and cannot turn into another, and therefore mutate in the process of transformation. After extracting them, we perform rigorous quality and biosafety screening before returning them to body.

All stem cell cultures and biopsies have infection screening, as well as screening for bacterial factor. A 3-step screening is always carried out: screening and checking the patient / donor, checking the biopsy and checking the final product / treatment dose of stem cells. Thus, the product consists only of clean stem cells.

According to safety protocols and a flow chart, our team cultivates stem cells in an oxygen-free environment, and the preservative has an antibiotic / antimycotic in order to prevent contamination at the stage of material collection and transportation.

Donor stem cells are obtained from young, healthy volunteers. These cells are subjected to intense biosafety and quality testing, and are accompanied by a cell product passport. Cells that are screened in this way are as safe and effective as your own cells.

Years back I had septum and turbinate surgery and this has damaged my nose. Today it’s to open and I get extremely dry witch cause nerve pain and burning sensation when inhaling. I’m also very sensitive to warm and cold air, to any strong scent or to smoke. Furthermore the mucosa, especially in the right nostril has gotten into Secondary Atrophic Rhinitis and I have a hard time to feel the air in this nostril. Do you think that expanded stem cells can be used for this? And if! In what way do you think that they can help?

In the past, we have experience using stem cells to treat empty nose syndrome. Potentially, using stem cells can help you, but first we need to confirm your diagnosis. Then we should determine if stem cells are applicable to you.

Then the doctor will determine the type and dose of stem cells, taking into account your general condition and concomitant diseases.

The use of stem cells can improve the trophic function of the nasal passages, increase the performance of nerve fibers of the nasal mucosa. In general, this will improve your nasal mucosa.

Can you arrange so that I can get help from a skilled doctor to get injections done in the nose?
Also, injection in the nose is a high risk area since there is blood vessels that connect to the eye, how can the doctor avoid causing blindness from the injection?

In our team, we have an ENT specialist who performs surgical operations and injections and other manipulations. His experience is over 15 years. We have no negative experience with such medical procedures. We guarantee high quality medical services in the clinic.

The doctor makes an injection in the nose with a special device, so there is no risk of vascular damage or infection.

Have you treated other people with Empty nose syndrome / Secondary Atrophic rhinitis?
Do you have any records of the treatments?

For other cases in ilaya, most of patients were diagnosed with chronic rhinitis (absence/deformation of the nasal mucosa). Patients told, that they received following improvements:

56% of patients reported about improvement of symptoms of paradoxical obstruction

75% of patients reported about decreasing of complaints regarding dysautonomia (autonomic nervous system dysfunction)

31% of patients reported about decreasing of complaints regarding manifestations of hyperventilation

43% of patients reported about decrease in chronic dry nose

36% of patients reported about decrease in pain in the nose

50% of patients reported about decrease in chronic fatigue and stabilization of sleep.

Data obtained from medical reports of patients compiled by their doctors.

What’s unique with your clinic, why should I use this clinic for storage and expansion of cells?

We use adult cultured stem cells. We do not buy them in another laboratory, but do them ourselves in our the Cell Cultures and Tissue Engineering Laboratory. It is one of the few laboratories in Ukraine that allows you to receive different types of adult cells and tissue and engineering materials. Laboratory staff tirelessly improves its skills and conduct scientific research.

The pride of our laboratory is the manufacturing of neural fate directed stem cells, which are highly effective in treatments of neuronal diseases and in brain anti-ageing treatments.

In addition, in the laboratory there are boxes with laminar flow of air for laboratory manipulations, CO2 incubators for cultivating human cells.

Our lab is unique in Ukraine in performing anaerobic cell cultivation (i.e. cultivation in an oxygen-free environment). This prevents ageing and genotoxic stress in the cells.

We focus on treatments using adult stem cells, either from the patient’s own body or from donors. All of ilaya’s stem cell products have an individual cell identity, biosafety, potency and product quality passport. It has information about the patient, origin, composition, expiration date, date of manufacture and volume of the medical product is recorded.

To create your personalised stem cell bank, we take a minimal tissue sample from your body. We usually take half a square centimetre of skin containing hair follicles from behind your ear (so the site is hidden from view). That’s all we need to grow millions or even billions of cells for you. No surgery. No incisions. Completely invisible. This procedure needs to be done only once.

ilaya’s Cryobank facility allows our patients to store bio-materials for an unlimited amount of time. We use EU storage protocols to preserve the quality and safety of materials. Having our own facility also eliminates the possibility of errors during transport.

Also I do have 2 herniated discs and one bulging disc, one in the neck and two in the lower back. Is this something that can be treated with stem cells? How do you do that? Can cells be injected in the disc or will that damage the disc even more? If this can be done, how much will that cost?

We have a program for the treatment of herniated discs using stem cells.

Stem cells are injected paravertebrally. Injection into the disk itself is not carried out since there is a real risks of damaging the disk itself. The stem cell product is introduced near the posterior longitudinal ligament. Stem cells have a function of migration to damaged tissues. We use this possibillyty. Therefore, the injection is done as close as possible but not to the disk itself. Simultaneously, we use injections of growth factors and PRP are given, which dates the opportunity to improve tissue nutrition, enhances the effect of stem cells.

For guide you about the cost of treating herniated discs and one bulging disc, we need to determine the dose and type of stem cells first. It is necessary that you give more information about your diagnosis please. Usually we useMultipotent mesenchymal stromal/stem cells from human adipose tissue (AT-MSCs).

Typically, a course of treatment consists of 2 to 4 paravertebral injections and costs between 4,500 and 8,000 euros.

For the nose and the back, how many injections with expanded stem cells do you recommend, how much per do you charge per injection? And in what intervals do you recommend the injections?

Usually we recommend having 1 course for the nose first where the 1st injection is MSCs from adipose tissue and the 2nd injection is Multipotent mesenchymal stem cells – neural crest-derived (NC-MSC).

Next, we evaluate the results after 2 months and see what indicators have improved. Based on that, we can offer to repeat the course, if necessary. For the back, we recommend taking 1 course as well. 2 introductions of mesenchymal stem cells in a basic course.

Prices are selected individually. They depend on the length of stay of the patient in the clinic and the dose of stem cells of course. The range for the program is from 4 to 6 K euros per treatment course; for the back - 6-8 K euros.

When you expand the stem cells, how many cells would there be per milliliter?

In order to prepare a therapeutic dose, we use a hair follicle. The biopsy sample is screened and then the master bank is formed. A therapeutic dose of stem cells is production from the master-bank. Millions of stem cells are not counted in milliliters. Any number of stem cells can be prepared for any type of injection / dropper into the body. According to this, the amount of liquid is selected.

Is there a limit in how many times I can use my stored cells? Can they last forever or do I eventually run out of cells?

There are no limits, cells can be stored forever.

During the cell expansion I know that it’s possible to expansion certain cells if growing factors are introduced to the cells. Is this something you do? Or do you just expand all the cells from my adipose tissue?

Yes, this is what we do. We expand your stem cell without loss of their quality.

Do you have a waiting list?
No, we don’t have any waiting list.

Do you have any studies over your treatments?
Our experience is 16 patients with different disorders of the mucous membrane, mostly with Chronic Rhinitis.

Can I communicate in English with the clinic and with the doctors who will do the injections?
You will have your personal manager, who will assist with translations.

Questions to Ilaya 2019-10-15

You told me that it cost from 1500 Euro per type of stem cell to store. How many different kind of stem cells can you produce and store? What will the specific stem cell help to regenerate?

We can cultivate 3 types of stem cells after one punch-biopsy: MMSC fat cells, dermal fibroblasts and neural crest cells. This punch-biopsy is done behind the ear, we’ll take one hair follicle and a little amount of skin around.

How much would it be to store all kind of stem cells that you can produce?

For now the storage price is 3025 UAH. The longer you store, the bigger discount you get.

You told me that you take a piece of skin behind the ear to use to extract stem cells from. How big slice is this? Can you extract all kind of stem cells from this piece? Do you need fat to?

Usually the sizes are 2x2 mm, the depth is not more than 4mm. We don’t need to take fat additionally.
The types of stem cells cultivated are: MMSC fat cells, dermal fibroblasts and neural crest cells.

Do I need to store my stem cells for life or is there any other way to do this? I was talking to another patient that was told that you can save the cells for one year so he can come back to get more injections within one year. How much will that cost?
You can store your stem cells all your life or extract them every time after biopsy.
Yes, you’re right. When our patient gets treatment with a dose of stem cells, we keep his bank during one year. This gives him the opportunity to repeat the course, but not to do a punch biopsy again, and also to cultivate cells in advance, before the day of arrival.

Is there any waiting time to see the clinic to leave my stem cells for expansion? 
How quick can I get an appointment?
No problems with this. We do biopsy from different patients every day. It takes 2-3 hours, including paperwork. You’ll have the opportunity to do this without waiting.

After injection of stem cells, how long time will those stem cells regenerate the mucosa? The reason why I ask is that I will get cartilage implants to from another doctor to close of my over opened nose. How long time after stem cell injections do you think I should wait to get cartilage implant surgery not to destroy any of the healing process from the stem cells?
The regeneration takes up to 1 year, first results are seen in 1.5-3 month. The implants can be installed in one month after injections.

My nose is very open now and it’s very easy for the doctor to inject stem cells any were, when I get cartilage implants the nose will be narrower. It could be harder to inject stem cells. Do you recommend that I will do the injections before cartilage implants or after? or both before and after?
The injections should be done before the cartilage implants. Then in 3 month we’ll ask you about the results and the doctor will advise if you need additional injections.

When it’s about the injections, do you know if the doctor will inject at many spots in the nasal mucosa or just at one spot?
The doctor will decide how many inflections do you need. The dose of stem cells is fixed, but there may be several injections.

My problem is mainly Atrophy of the nasal mucosa, I’m dry and the nasal mucosa looks pale and don’t produce any or very little mucus. The remaining part of the turbinate’s, especially the right inferior one looks damaged. It’s pale, white and the surface looks more like skin than mucosa. What kind of stem cells would you recommend me to have to try to regenerate a healthy functional mucosa?
MMSC fat cells - we always start with them. Later, according to the indications, there may be neural crest cells too.

How many injections with expanded stem cells do you recommend that I get to treat atrophic rhinitis and how long should it be between the injections? How much will each injection cost?
The doctor will decide how many inflections do you need. It doesn’t matter, how many injections will be done. The patient pays for the dosage of stem cells, but not for the number of injections.

How long time should there be between the first injection and the second injection?
Answer: 4-5 weeks

Price and info from a second source.
Autologous neuro crest stem cell: starts at 4600 Euros for 2 injections
Neural crest is a Mesenchymal stem cell that is used to heal and regrow nerves.

Person 1, (I) payed 2000 euro for 2 injections with Ilaya but then he had left stem cells for many years back that was already paid for. Ilaya only needed to culture those cells again. 
This person claims that he is les dry and have more mucus in his nose after injections with stem cells. No side effects was reported besides being a bit swollen for a few days after.

Email from person 2 (A) to Ilaya, they reply 2019: Donor stem cells are completely safe. Totaly you can use your own stem cells (known as autologous use) or cells from a donor (allogeneic use). However, only your doctor makes the choice to use their own / donor cells. Sometimes your own cells may not be effective for treatment. The main factors are age, previously transferred diseases, the presence of neuro-degenerative diseases, allergies, and the state of the immune system.
Donor stem cells are obtained from young, healthy volunteers. These cells are subjected to rigorous biosafety and quality testing, and are accompanied by a cell product passport. Cells that are screened in this way are equally safe and effective as autologous cells. They are cultured and then stored in a cryobank, and are often used in cases where there is no time to grow enough of the patient’s own stem cells to yield a therapeutic dose.
We have 5 billion donor stem cells permanently in our cryo bank.

Usually, to restore the mucous membranes, own cells are often used, but the doctor always analyzes the diagnosis first and then together with the patient, they make a decision.

If donor stem cells are applicable to the patient, the procedure usually takes 2 days.
The first day - checking the diagnosis and preparation.
The second day is a stem cell injection procedure and observation of the patient's condition.

In any case, you should first talk to the doctor. This does not oblige you to anything and cost you nothing, but you can ask your questions to a specialist, clarify a personal prognosis of treatment, and receive clarifications about the safety of stem cells for you.

In my opinion, it is very important if you could get trust the doctor and understand the effectiveness of the treatment before starting this journey.

Please email me if you have any more questions. I'll be glad to help.

If you decide to continue, before you will have a Skype call with a doctor, I should get your answers to the medical questionnaire.

Ilaya Emty nose syndrome treatment program, september 2019

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All donations received as of 31/12 each year will go to patients in need for reconstruction of the nose. Donations and people who receive them will be featured on the blog after the donation is transferred at the beginning of the following year. All amounts are welcomed via Paypal. Note that the amount is in USD.

2 kommentarer:

  1. It has been some time since I visited website with such high quality information. Thank you so much for providing such helpful information. This is really informative and I will for sure refer my friends the same. Thanks.
    Personal Injury Frankfort

  2. Hope you have luck with the stem cell. I'm looking for it as well.