Choice of Stem Cells

[mrbrightside614]

For those who are better read on the subject, is there any benefit of using

1) mesenchymal stem cells (MSC's),

2) umbilical cord mesenchymal stem cells (UCMSC's) or

3) induced pluripotent stem cells (IPSC's) over autologous stem cells for the purpose of eliminating tinnitus?

I've recently contacted Stem Cells 21 and received this response to my inquiries about treating tinnitus, where they indicate that they will be using IPSC's by 2020. I have a few issues with my neck/spine, and I know there are places in the United States that use autologous stem cells to address local injury sites that are much more cost effective, but knocking out all of these issues with a single reputable source would be far preferable to me. Thanks in advance.

@Contrast @JohnAdams @ChrisBoyMonkey

 

[vermillion]

For those who are better read on the subject, is there any benefit of using

1) mesenchymal stem cells (MSC's),

2) umbilical cord mesenchymal stem cells (UCMSC's) or

3) induced pluripotent stem cells (IPSC's) over autologous stem cells for the purpose of eliminating tinnitus?

I've recently contacted Stem Cells 21 and received this response to my inquiries about treating tinnitus, where they indicate that they will be using IPSC's by 2020. I have a few issues with my neck/spine, and I know there are places in the United States that use autologous stem cells to address local injury sites that are much more cost effective, but knocking out all of these issues with a single reputable source would be far preferable to me. Thanks in advance.

View attachment 33246

@Contrast @JohnAdams @ChrisBoyMonkey

Does anybody know what is the situation with that clinic?

They don't list tinnitus anymore on their website.

As far as I know, 3 former members of this forum had success. Are there more?

Is there somebody who has looked on that route to provide more information?

 

[MadsWithT]

Does anybody know what is the situation with that clinic?

They don't list tinnitus anymore on their website.

As far as I know, 3 former members of this forum had success. Are there more?

Is there somebody who has looked on that route to provide more information?

I've been in touch with SC21 recently. They do stem cell treatment for hearing loss/tinnitus. I've sent them and a few other clinics a list of questions. SC21 has obviously found a niche they have had success with. I can post my questions and the answers if you are interested.

 

[vermillion]

I've been in touch with SC21 recently. They do stem cell treatment for hearing loss/tinnitus. I've sent them and a few other clinics a list of questions. SC21 has obviously found a niche they have had success with. I can post my questions and the answers if you are interested.

Thank you very much for this. I would appreciate that. Are you planning to go down that route?
Would you also recommend other clinics?
If you want you can PM me.

 

[Chinmoku]

I've been in touch with SC21 recently. They do stem cell treatment for hearing loss/tinnitus. I've sent them and a few other clinics a list of questions. SC21 has obviously found a niche they have had success with. I can post my questions and the answers if you are interested.

Yes please. Stem cells are desperate measures, and quite expensive. The more we know about it, the best.

 

[all to gain]

As far as I know, 3 former members of this forum had success. Are there more?

Really, who exactly? What degree of success? The reports I've seen have hardly been conclusive.

When someone spends a shitload of money on something like stem cells they are probably more likely to say something was a success rather than to lose face. Maybe I'm wrong though.

That said, if FX-322 fails to materialise.... then stem cells it might have to be!! Got to find the $$$!!

 

[MadsWithT]

@vermillion
I'll post the questions and answers from SC21.
It's a little bit of work. I'll try to get to it later today.

 

[Chinmoku]

@vermillion
I'll post the questions and answers from SC21.
It's a little bit of work. I'll try to get to it later today.

Information I had from last year is that in 2020 they would offer iPSC cells generated from the patient skin. This is the best approach, apparently. However, the packages involving storing the iPSC cells and using them over a prolonged period of time were above my financial possibilities. So I need to go probably for more traditional MSC cells that are cheaper. Packages with MSC I could afford, with some effort, but that would leave me with zero funds to attempt anything else, and we need to keep some funds for when FX-322 hits the market, OTO-413, etc. Honestly, I don't know how I can survive with this tinnitus that long, and SC21 would be ready to operate now, but burning all my finances would be the final make or break and if it fails I would be doomed. Also, there is no long term literature on the safety of this stuff re:cancer and other issues, and honestly, on the efficacy, anecdotes of three people are not overly reassuring, I would like to see some real data. It also bothers me that there are no clinics in Europe or US that use this for tinnitus and other specific ailments, the clinics we heard of are in Thailand, China and Russia (the latter named, comically enough, Swiss Medica).

 

[vermillion]

Really, who exactly?

@attheedgeofscience has provided extensive reports on his SC journey and its outcome. It's in this forum.
@undecided reported improvement 8 months post-treatment
the other guy I don't recall, I think his avatar was the logo of Arsenal?

@vermillion
I'll post the questions and answers from SC21.
It's a little bit of work. I'll try to get to it later today.

@MadsWithT I have to thank you in advance for that. There's no rush apparently. Whenever it's comfortable for you.

the packages involving storing the iPSC cells and using them over a prolonged period of time were above my financial possibilities

Could you disclose an estimated quotation?

that would leave me with zero funds to attempt anything else, and we need to keep some funds for when FX-322 hits the market, OTO-413, etc

I do understand and share the concern, but I would worry about the ability to cover other expenses that life demands (such as emergency medical care) and not FX-322 or OTO-413. I understand the desperation for an actual treatment, however these methods might never make it to the market. In fact that is the most possible scenario given the current research, statistics etc.

I don't know how I can survive with this tinnitus that long, and SC21 would be ready to operate now, but burning all my finances would be the final make or break and if it fails I would be doomed.

I hear you! At least you have the funds. I don't. I do try to figure out a possible plan for this.

Also, there is no long term literature on the safety of this stuff re:cancer and other issues, and honestly, on the efficacy, anecdotes of three people are not overly reassuring, I would like to see some real data. It also bothers me that there are no clinics in Europe or US that use this for tinnitus and other specific ailments, the clinics we heard of are in Thailand, China and Russia (the latter named, comically enough, Swiss medica).

I can't blame you. It is true. My reasoning is to try that instead of committing suicide, because I can't survive this too. But if, just IF, there's even a 1% of possibility to benefit from this, I would like to exhaust this last chance. In regards to cancer, few months ago I would naively say that I wouldn't care, but witnessing my father dying from it... it was inhumane. It transform you in something else. You are just a mere imprint of your former self. A shadow. And it was torturous. My father could not find even a second of peace during his final days. Until he died.

Bottom line:
We are running like mice through a maze in hell!

 

[Chinmoku]

Could you disclose an estimated quotation?

We are talking hundreds of thousands of dollars, I need to dig out the email I had got, but storage and administration of a relevant amount of cells over a few sessions would cost hundreds of thousands. Let me double check though.

I do understand and share the concern, but I would worry about the ability to cover other expenses that life demands (such as emergency medical care) and not FX-322 or OTO-413. I understand the desperation for an actual treatment, however these methods might never make it to the market. In fact that is the most possible scenario given the current research, statistics etc.

I don't know, you are wise to think like that but right now this tinnitus is literally killing me. I don't know how much longer I can hang it together. For me it's survival.

I can't blame you. It is true. My reasoning is to try that instead of committing suicide, because I can't survive this too. But if, just IF, there's even a 1% of possibility to benefit from this, I would like to exhaust this last chance. In regards to cancer, few months ago I would naively say that I wouldn't care, but witnessing my father dying from it... it was inhumane. It transform you in something else. You are just a mere imprint of your former self. A shadow. And it was torturous. My father could not find even a second of peace during his final days. Until he died.

Bottom line:
We are running like mice through a maze in hell!

Sorry to hear about your father, vermillion, really sorry. I lost a friend to cancer recently and even with all the palliative care they administered it was horrible. I was crying and crying in the bus coming back from my last visit to him. Having said that, what I find torturous of severe/catastrophic tinnitus and hyperacusis is that it does not kill you, it can go on years and years and leave you an empty shell of suffering. You may recover, it's true, which is an option cancer patients often don't have, but how many severe cases recover? Cancer will eventually kill you, it's horrible, but there is an end in sight, you will receive palliative care that can be more or less effective, but there is a framework, a process, it's recognized, you will be treated, and if it does not work the suffering has an end in sight. This stuff we have can go on for decades and you suffer in hell until finally you die for some other cause or you decide to pull the plug. I agree with trying everything though, as long as I have energy and I am not too agonizing, because this horror robs you also of your energy and ability to plan and act. Stay strong my friend.

 

[MadsWithT]

Guys. This is the response I got from SC21.

I contacted 4 clinics in total. One here in Norway and one in Thailand did not respond.
Swiss Stem Cells did respond but has yet to send a reply to my questions. I sent the request in early April.

Currently I am researching a treatment. I started LLLT only 5 weeks after adverse effect of Lenire. The laser protocol has already worked by "flattening" the asynchronous pulsating tinnitus I got from using Lenire for 9 days.

Right now I am keeping all options open. Stem cell treatment at SC21 would be around $100,000 USD.

*******************************************************************
Dear Mads,

First of all please let me introduce myself.
I am Dr. Thein Htut, Medical Director of Stem Cells 21 in Bangkok, Thailand.
Thanks for sending all the questions and the further information you would like to get from us.

Here are my answers below to all your questions.

1. How many patients have you treated for this condition? What year did you first treat patients for this condition?

Answer: We have treated over 15 patients. The first patient was treated in 2013.

2. What is the success rate? How many(percentage, number) have seen a. full improvement. b. partial/some improvement. c. No improvement d. Worsening of condition.

Answer: Our success rate is around 50-75% depending on the clinical conditions and the chronicity of the patient (how long/how many years the patient has the condition)
There is no 100% improvement of the condition. But if there is even 35-50% that is a lot of improvement.
We have seen over 10 patients, gradual improvements within 6-8 months after the stem cells injections their hearing loss improves a lot. They can evaluate whether they are improving by knowing that they have to adjust the hearing aide volume control to a lower level, because they are hearing better than before. Regarding the tinnitus, we have many patients improved within 4-6 months and they feel much better in their normal life, back to their normal business and attending meetings and even back to giving presentations and speeches.
We have not seen any patients without improvement or that has worsened.

3. How long time does it take for the SC to work in this particular case? Seeing that blood flow to the inner ear is limited, how can SC get to the "right place". How can SC be targeted to help this condition?

Answer: AS mentioned above improvement in hearing will take a little longer around 6-8 months and for tinnitus 4-6 months.

After the stem cells are injected in front of the ear around the the tragus, crus of helix, anti-tragus and near the ear lobe plus the intra-nasal inhalation of the stem cells, the stem cells will migrate to the middle ear via circulation and tissue permeability. In this way the stem cells will start to repair regenerate the hair cells in the cochlea, the auditory nerve and also by improving the damage in the area of the brain (if this is the cause of the hearing loss).

4. What other treatment does you clinic perform in order to supplement treatment for hearing loss/tinnitus i.e LLLT, Oxygen etc?

Answer: After stem cells injections to the specific areas mentioned above, Medical Laser is directed to the middle of the ear towards the tympanic membrane (the laser fiber will not be piercing the tympanic membrane but the infra red medical laser will emit the light towards the tympanic membrane thus enhancing the stem cells that will migrate to the middle ear around the cochlea and the hair cells.
This laser therapy is given every day for 30 minutes duration.
Daily Oxygen therapy is also given intravenously .
5. What strategy do you employ/recommend in regards to administration of the SC? i.e. IV, Injection near the ear, in the inner ear, through the nose or other methods.
Answer: Stem cells are given via
1) IV infusion
2) Local injections around and in front of the ear (as mentioned above)
3) Intra-nasal inhalation

6. What would be the duration of one whole treatment? i.e. how long time, number of sessions.

Answer: The daily duration of the whole treatment will take around 2 hr 30 minutes to 3 hrs.
The duration of the treatment program depends on the number of stem cells used.
100 million P1 UCMSC cells therapy x 6 days treatment program ( 6 consecutive days treatment)
200 million P1 UCMSC cells therapy x 8 days treatment program (8 consecutive days treatment)

7. How many stem cells would you administer per session?

Answer: As mentioned above: (P1- UCMSC: Passage 1 Umbilical Cord Mesenchymal Stem Cells)
Using 100 million P1 UCMSC, we will inject more cells on the worse ear (whether it is left or right ear). If the problem is the same we will inject the same number of cells.
- 30 million UCMSC cells on each side of the ear.m (total 60 million)
- 20 million UCMSC cells intra-nasal inhalation
- 20 million UCMSC cells IV infusion

Using 200 million P1 MSC, we will inject more cells on the worse ear (whether it is left or right ear). If the problem is the same we will inject the same number of cells.
- 75 million MSC cells on each side of the ear.m (total 150 million)
- 15 million MSC cells intra-nasal inhalation x 2 times (total 30 million)
- 20 million MSC cells IV infusion

8. How many SC would be administered in total?

Answer: Either 100 or 200 million depending on the patient's decision to accept the recommended number of cells from our Stem Cells 21 specialist.

9. How many sessions/days per treatment

Answer: Daily treatment is 1 session that will last 2 and half to 3 hours.

10. Would there be injection of SC on subsequent days?

Answer: We have our protocol to separate the local injections, intra-nasal inhalation and IV infusions depending on the conditions of the patient and after physical examination of the patient at our medical center.
Most of the stem cells are given alternate days with other IV nutrition are given in between the stem cells injection/infusion.

11. What type of stem cells would you use or recommend during the period of treatment?

Answer: We use P1 Umbilical Cord Derived Mesenchymal Stem Cells (P1 UCMSC) that we process, harvest and culture in our own lab that is under the same roof with our medical center SC21. For your information, we DO NOT purchase the stem cells from any other stem cells lab.

12. What clinical evidence do you have for this type of SC treatment?

Answer: UCMSC Mesenchymals stem cells are proven for treating many diseases that cannot be treated by the normal conventional treatments.

13. Are there clinical research that has proven the efficacy of this type of SC treatment?

Answer: Yes there are many published papers on the use of UC MSC cells for different kind of health issues.

14. Is this type of SC treatment safe?

Answer: Yes, UCMSC cells are safe to use without needing to test for HLA matching as it has the immune privilege. It has not side effect or complications whatsoever. We have treated over thousands of many kind of diseases using this stem cells with out any side effects and complication, but with improvement in their clinical conditions as well as their Quality of Life.
15. How do you produce the SC?

Answer: As mentioned above, we process our umbilical cord mesenchymal stem cells in our own lab.

Once we collected the umbilical cord from the donor (from the mother after the health baby is born), we start to process it withing 24 hour after receiving the cord tissue. We do not cryo freeze the cord tissue but process it within 24 hours. It takes 30 days to get the young naive stem cells and once we get the MSC cells than we will bank the MSC cells in our Cryo-storage that we store under - minus 168 degree Celsius. And when we need to use the stem cells we have billions of UCMSC stored in our Cryo-storage and can he used straight away when the patient comes to our clinic.


I hope the above answers will give you a better understanding how we treat the health issues using our P1 UCMSC cells therapy.


Thanks for trusting in our treatment and services.
Take care and have a wonderful day ahead.
************************************************

Stay at home and stay safe from the COVID-19.

 

[all to gain]

Guys. This is the response I got from SC21.

I contacted 4 clinics in total. One here in Norway and one in Thailand did not respond.
Swiss Stem Cells did respond but has yet to send a reply to my questions. I sent the request in early April.

Currently I am researching a treatment. I started LLLT only 5 weeks after adverse effect of Lenire. The laser protocol has already worked by "flattening" the asynchronous pulsating tinnitus I got from using Lenire for 9 days.

Right now I am keeping all options open. Stem cell treatment at SC21 would be around $100,000 USD.

*******************************************************************
Dear Mads,

First of all please let me introduce myself.
I am Dr. Thein Htut, Medical Director of Stem Cells 21 in Bangkok, Thailand.
Thanks for sending all the questions and the further information you would like to get from us.

Here are my answers below to all your questions.

1. How many patients have you treated for this condition? What year did you first treat patients for this condition?

Answer: We have treated over 15 patients. The first patient was treated in 2013.

2. What is the success rate? How many(percentage, number) have seen a. full improvement. b. partial/some improvement. c. No improvement d. Worsening of condition.

Answer: Our success rate is around 50-75% depending on the clinical conditions and the chronicity of the patient (how long/how many years the patient has the condition)
There is no 100% improvement of the condition. But if there is even 35-50% that is a lot of improvement.
We have seen over 10 patients, gradual improvements within 6-8 months after the stem cells injections their hearing loss improves a lot. They can evaluate whether they are improving by knowing that they have to adjust the hearing aide volume control to a lower level, because they are hearing better than before. Regarding the tinnitus, we have many patients improved within 4-6 months and they feel much better in their normal life, back to their normal business and attending meetings and even back to giving presentations and speeches.
We have not seen any patients without improvement or that has worsened.

3. How long time does it take for the SC to work in this particular case? Seeing that blood flow to the inner ear is limited, how can SC get to the "right place". How can SC be targeted to help this condition?

Answer: AS mentioned above improvement in hearing will take a little longer around 6-8 months and for tinnitus 4-6 months.

After the stem cells are injected in front of the ear around the the tragus, crus of helix, anti-tragus and near the ear lobe plus the intra-nasal inhalation of the stem cells, the stem cells will migrate to the middle ear via circulation and tissue permeability. In this way the stem cells will start to repair regenerate the hair cells in the cochlea, the auditory nerve and also by improving the damage in the area of the brain (if this is the cause of the hearing loss).

4. What other treatment does you clinic perform in order to supplement treatment for hearing loss/tinnitus i.e LLLT, Oxygen etc?

Answer: After stem cells injections to the specific areas mentioned above, Medical Laser is directed to the middle of the ear towards the tympanic membrane (the laser fiber will not be piercing the tympanic membrane but the infra red medical laser will emit the light towards the tympanic membrane thus enhancing the stem cells that will migrate to the middle ear around the cochlea and the hair cells.
This laser therapy is given every day for 30 minutes duration.
Daily Oxygen therapy is also given intravenously .
5. What strategy do you employ/recommend in regards to administration of the SC? i.e. IV, Injection near the ear, in the inner ear, through the nose or other methods.
Answer: Stem cells are given via
1) IV infusion
2) Local injections around and in front of the ear (as mentioned above)
3) Intra-nasal inhalation

6. What would be the duration of one whole treatment? i.e. how long time, number of sessions.

Answer: The daily duration of the whole treatment will take around 2 hr 30 minutes to 3 hrs.
The duration of the treatment program depends on the number of stem cells used.
100 million P1 UCMSC cells therapy x 6 days treatment program ( 6 consecutive days treatment)
200 million P1 UCMSC cells therapy x 8 days treatment program (8 consecutive days treatment)

7. How many stem cells would you administer per session?

Answer: As mentioned above: (P1- UCMSC: Passage 1 Umbilical Cord Mesenchymal Stem Cells)
Using 100 million P1 UCMSC, we will inject more cells on the worse ear (whether it is left or right ear). If the problem is the same we will inject the same number of cells.
- 30 million UCMSC cells on each side of the ear.m (total 60 million)
- 20 million UCMSC cells intra-nasal inhalation
- 20 million UCMSC cells IV infusion

Using 200 million P1 MSC, we will inject more cells on the worse ear (whether it is left or right ear). If the problem is the same we will inject the same number of cells.
- 75 million MSC cells on each side of the ear.m (total 150 million)
- 15 million MSC cells intra-nasal inhalation x 2 times (total 30 million)
- 20 million MSC cells IV infusion

8. How many SC would be administered in total?

Answer: Either 100 or 200 million depending on the patient's decision to accept the recommended number of cells from our Stem Cells 21 specialist.

9. How many sessions/days per treatment

Answer: Daily treatment is 1 session that will last 2 and half to 3 hours.

10. Would there be injection of SC on subsequent days?

Answer: We have our protocol to separate the local injections, intra-nasal inhalation and IV infusions depending on the conditions of the patient and after physical examination of the patient at our medical center.
Most of the stem cells are given alternate days with other IV nutrition are given in between the stem cells injection/infusion.

11. What type of stem cells would you use or recommend during the period of treatment?

Answer: We use P1 Umbilical Cord Derived Mesenchymal Stem Cells (P1 UCMSC) that we process, harvest and culture in our own lab that is under the same roof with our medical center SC21. For your information, we DO NOT purchase the stem cells from any other stem cells lab.

12. What clinical evidence do you have for this type of SC treatment?

Answer: UCMSC Mesenchymals stem cells are proven for treating many diseases that cannot be treated by the normal conventional treatments.

13. Are there clinical research that has proven the efficacy of this type of SC treatment?

Answer: Yes there are many published papers on the use of UC MSC cells for different kind of health issues.

14. Is this type of SC treatment safe?

Answer: Yes, UCMSC cells are safe to use without needing to test for HLA matching as it has the immune privilege. It has not side effect or complications whatsoever. We have treated over thousands of many kind of diseases using this stem cells with out any side effects and complication, but with improvement in their clinical conditions as well as their Quality of Life.
15. How do you produce the SC?

Answer: As mentioned above, we process our umbilical cord mesenchymal stem cells in our own lab.

Once we collected the umbilical cord from the donor (from the mother after the health baby is born), we start to process it withing 24 hour after receiving the cord tissue. We do not cryo freeze the cord tissue but process it within 24 hours. It takes 30 days to get the young naive stem cells and once we get the MSC cells than we will bank the MSC cells in our Cryo-storage that we store under - minus 168 degree Celsius. And when we need to use the stem cells we have billions of UCMSC stored in our Cryo-storage and can he used straight away when the patient comes to our clinic.


I hope the above answers will give you a better understanding how we treat the health issues using our P1 UCMSC cells therapy.


Thanks for trusting in our treatment and services.
Take care and have a wonderful day ahead.
************************************************

Stay at home and stay safe from the COVID-19.

What's the difference between this and something like @JohnAdams had?

At $100,000 it is out of the reach of most on here.

 

[vermillion]

@MadsWithT
Thank you. That's pretty informative.
I thought the price was around $30,000-$40,000.

 

[vermillion]

Our success rate is around 50-75% depending on the clinical conditions and the chronicity of the patient (how long/how many years the patient has the condition)

I wonder if there's a limit. Like a window period.

 

[MadsWithT]

@MadsWithT
Thank you. That's pretty informative.
I thought the price was around $30,000-$40,000.

True. Per pop. You apparently need 2. They sent me the price list as well.

 

[MadsWithT]

What's the difference between this and something like @JohnAdams had?

At $100,000 it is out of the reach of most on here.

You'll find a good deal of info here on Tinnitus Talk regarding @JohnAdams's PRP treatment. This procedure is done intratympanically. Several injections through the eardrum over many days. This procedure is very cutting edge. SC21 say they are not doing this kind of treatment because of the risks. There is at least one very good thread about the intratympanic PRP treatment for tinnitus on Tinnitus Talk. Find it and read it.

 

[lcj]

Hi guys,

Just a quick note. All the prices quoted so far are for P1 (passage 1) cells. Passaging refers to how many times the cells are expanded. One passage is usually about 4-10 cell doublings and means the cells have reached 100% confluence (covered the bottom) of the flask they have been grown on.

SC21 has a 3 tiered pricing (at least as of 2019 when I inquired). Their passage 1 cells are the most expensive (and this is the price they usually quote), their passage 3 cells are usually quite a bit cheaper (I recall this price being 50-60% of the cost of P1 cells but don't hold me to that). Passage 3 again just indicates the cells have been cultured to 100% confluence 3 times in a flask (This is roughly 8^3 = 512 doublings). And lastly, they offer autologous adipose stem cell treatment which is by far the cheapest of the three (At around 20% of the cost of the P1 cells as I recall off the top of my head). There is also the option to bank adipose stem cells for treatment later on (separate from the IPSC program). So if any of you are interested in the treatment but not sure about the cost I would inquire about the P3 and adipose cells.

The majority of scientific papers published on Mesenchymal stem cells evaluating their safety and efficacy have been conducted on cells from passages 3-5. The literature shows that stem cells from passages 6 and beyond are less potent than those from passages 1-5. And after a certain number of passages (some where in the neighborhood of 12-15 I believe but again don't hold me to that as that is just a recollection) the cells will no longer divide.

As far as I know SC21 is one of the only SC companies to offer passage 1 cells, this is because they believe these cells have the maximum potency. They are expensive because one passage 1 cell could create 64 passage 3 cells so by using it early you are depleting your supply much quicker.

Also, the 2 other people on Tinnitus Talk who have had benefit from SC21 cells are:
@LJMD
@FERNANDO GIL

Hope this helps.

 

[FGG]

They aren't giving it intratympanically? They responded by saying they inject the SCs around the ear pinna so that they will eventually "diffuse into the middle ear" and then, later, via circulation (not diffusing through the round membrane) get into the cochlea.

How, exactly?

 

[Chinmoku]

They aren't giving it intratympanically? They responded by saying they inject the SCs around the ear pinna so that they will eventually "diffuse into the middle ear" and then, later, via circulation (not diffusing through the round membrane) get into the cochlea.

How, exactly?

Excellent question. I would have thought intratympanic injections to be the very minimum. PRP in South Korea, FX-322, Audion all were administered intratympanically. Look at all the discussion on delivery in the FX-322 thread. Ok, we are talking about stem cells here, but how would they enter the cochlea precisely? I think this is a very legitimate question when you are asked $100k.
Also, 5 months is a long time to see improvements, how do we know these patients didn't heal naturally with time? Why 5+ months and not, say, 1 month?

Before spending $100k one could definitely ask for much stronger data and info.

 

[lcj]

They aren't giving it intratympanically? They responded by saying they inject the SCs around the ear pinna so that they will eventually "diffuse into the middle ear" and then, later, via circulation (not diffusing through the round membrane) get into the cochlea.

How, exactly?

I'm not sure as to the current policy, but as far as when I had corresponded with them in 2019 and through the stem cells Facebook group, they do offer intratympanic injection but only in severe cases and if the customer pushes for it. I think they offered it to a child who was very hard of hearing. This is for safety reasons as they don't feel that intratympanic is as safe as other methods of delivery (which I agree). As for whether their method of local injection along the 'meridians' of the ear works as well as intratympanic, I have not asked to see the research on that. Although anecdotally Clarice (the person at SC21 I corresponded with) mentioned that she thinks it is the most successful of their three methods of delivery, I recall @LJMD saying that he perceived a reduction in his tinnitus right away after the local injection, and there have been small scale studies conducted with other compounds using a similar method of delivery (the one I recall used Nerve Growth Factor) that did show efficacy. But mostly anecdotes, for what that is worth. Although that is definitely a question I would pose to their research director.

Here is a part of my correspondence with Clarice:

Only for that patient with no option treatment for hearing/tinnitus the problem, we will consider injecting the cells into the middle ear piercing the eardrum (tympanic membrane) and it will only be done with the decision after physical examination of the ear by our stem cell treating physician at our center.

As the direct injection into the middle ear may cause, such events as temporary dizziness, vertigo, pain, and bleeding. Rare risks include damage to ear bones (ossicles) and middle ear infections. That is why most of all the patient with hearing loss and tinnitus we treated is treated by injecting the cells as mentioned above, locally in front of the affected ear with much improvement with their follow up treatment also.

 

[ThomasC]

Your new hair cells may not innervate with the right nerve endings and would not grow in the right spots.

Thank you for having posted their answers, @MadsWithT.

The success rate is quite disappointing considering how expensive the operation is but their sample is very small and we don't have access to their data. I also find their answers quite vague. They didn't give an idea of how much hearing their patients recovered.

I'm also wondering if the stem cells can penetrate the cochlear deeply and reach the lower frequencies.

 

[FGG]

Hi guys,

Just a quick note. All the prices quoted so far are for P1 (passage 1) cells. Passaging refers to how many times the cells are expanded. One passage is usually about 4-10 cell doublings and means the cells have reached 100% confluence (covered the bottom) of the flask they have been grown on.

SC21 has a 3 tiered pricing (at least as of 2019 when I inquired). Their passage 1 cells are the most expensive (and this is the price they usually quote), their passage 3 cells are usually quite a bit cheaper (I recall this price being 50-60% of the cost of P1 cells but don't hold me to that). Passage 3 again just indicates the cells have been cultured to 100% confluence 3 times in a flask (This is roughly 8^3 = 512 doublings). And lastly, they offer autologous adipose stem cell treatment which is by far the cheapest of the three (At around 20% of the cost of the P1 cells as I recall off the top of my head). There is also the option to bank adipose stem cells for treatment later on (separate from the IPSC program). So if any of you are interested in the treatment but not sure about the cost I would inquire about the P3 and adipose cells.

The majority of scientific papers published on Mesenchymal stem cells evaluating their safety and efficacy have been conducted on cells from passages 3-5. The literature shows that stem cells from passages 6 and beyond are less potent than those from passages 1-5. And after a certain number of passages (some where in the neighborhood of 12-15 I believe but again don't hold me to that as that is just a recollection) the cells will no longer divide.

As far as I know SC21 is one of the only SC companies to offer passage 1 cells, this is because they believe these cells have the maximum potency. They are expensive because one passage 1 cell could create 64 passage 3 cells so by using it early you are depleting your supply much quicker.

Also, the 2 other people on Tinnitus Talk who have had benefit from SC21 cells are:
@LJMD
@FERNANDO GIL

Hope this helps.

Would love their and any one else's who went very specific feedback.

@FERNANDO GIL it seems that you were also a proponent of LLLT looking at your history. Since SC21 uses a laser to increase tympanic membrane permeability is it possible the laser itself was the beneficial factor (and significantly cheaper)? Or is it a totally different kind of laser?

 

[lcj]

Also, there is no long term literature on the safety of this stuff re:cancer and other issues, and honestly, on the efficacy, anecdotes of three people are not overly reassuring, I would like to see some real data

Regarding cancer, I have seen nothing in the literature or heard anything anecdotally to suggest that injection of umbilical or autologous Mesenchymal stem cells increases the risk of cancer. I believe that the only reports of increased cancer risk came from using embryonic stem cells (stem cells derived from blastocysts). The logic being that embryonic cells are pluripotent (can become a wide variety of cell types) versus the multipotent (can become a limited amount of cell types) ability of MSCs. Of course, the time period in question is relatively short, so that isn't to say we know all of the long long term risks, but I personally am not at all concerned about that angle of it.

I do want to point out though that for certain people, they may be more likely to have short term adverse reactions with stem cells. To begin with, depending on the clinic and type of cells, anywhere from 1-5% of people will likely report short term flu-like symptoms lasting from one day to a few days (this is rare) including a low-grade temperature, and lethargy after receiving the cells.

People who have active viral infections should take care of their active infections prior to getting stem cells. And in rare instances, viral reactivation (for instance herpes simplex virus) is known to occur after getting the cells. For people with Lyme disease or autoimmune conditions, another rare side effect is mast cell activation disorder. Also, it's important to point out that if someone has had Lyme disease in the past, they should get their CD57 Natural Killer cells tested before proceeding with stem cells. If their CD57 is not within normal range, the cells are likely to be ineffective.

 

[Chinmoku]

Hi guys,

Just a quick note. All the prices quoted so far are for P1 (passage 1) cells. Passaging refers to how many times the cells are expanded. One passage is usually about 4-10 cell doublings and means the cells have reached 100% confluence (covered the bottom) of the flask they have been grown on.

SC21 has a 3 tiered pricing (at least as of 2019 when I inquired). Their passage 1 cells are the most expensive (and this is the price they usually quote), their passage 3 cells are usually quite a bit cheaper (I recall this price being 50-60% of the cost of P1 cells but don't hold me to that). Passage 3 again just indicates the cells have been cultured to 100% confluence 3 times in a flask (This is roughly 8^3 = 512 doublings). And lastly, they offer autologous adipose stem cell treatment which is by far the cheapest of the three (At around 20% of the cost of the P1 cells as I recall off the top of my head). There is also the option to bank adipose stem cells for treatment later on (separate from the IPSC program). So if any of you are interested in the treatment but not sure about the cost I would inquire about the P3 and adipose cells.

The majority of scientific papers published on Mesenchymal stem cells evaluating their safety and efficacy have been conducted on cells from passages 3-5. The literature shows that stem cells from passages 6 and beyond are less potent than those from passages 1-5. And after a certain number of passages (some where in the neighborhood of 12-15 I believe but again don't hold me to that as that is just a recollection) the cells will no longer divide.

As far as I know SC21 is one of the only SC companies to offer passage 1 cells, this is because they believe these cells have the maximum potency. They are expensive because one passage 1 cell could create 64 passage 3 cells so by using it early you are depleting your supply much quicker.

Also, the 2 other people on Tinnitus Talk who have had benefit from SC21 cells are:
@LJMD
@FERNANDO GIL

Hope this helps.

Interesting, thanks for this. So with P3 cells both ears one could manage with $50.000 maybe, and still insist that they are administered intratympanically. From what you say P3 cells would still be effective.
Re: adipose cells, in previous correspondence they mentioned those are good for anti ageing but not for ear issues specifically.

 

[pinklights98]

@FGG

You are pretty informed about FX-322. Do you think getting something like this would conflict with potential results from FX-322?

 

[FGG]

@FGG

You are pretty informed about FX-322. Do you think getting something like this would conflict with potential results from FX-322?

Personally, I am highly skeptical that stem cells injected in this manner can do anything material to the cochlea at all.

Even this answer:

"12. What clinical evidence do you have for this type of SC treatment?

Answer: UCMSC Mesenchymals stem cells are proven for treating many diseases that cannot be treated by the normal conventional treatments."

Tells me they don't have much evidence.

Generally though, my impression is that the exosomes from stem cells do seem to have a broad anti inflammatory effect and reducing inflammation can have a big or small effect depending on the individual, as with any other anti-inflammatory protocol (e.g. NAC, anti inflammatory diet, etc).

I haven't seen any evidence they do anything structurally to the ear. In fact, all the studies I have read have shown that they fail to survive in vivo in the cochlea at all, even in small amounts.

Passage 1 cells with increased potency I suppose could be different but I would need to see the reported histology on what they specifically do.
I haven't found any studies that how these early phase expanded cells are achieving this milestone, though, to know what effects if any, are happening.

FX-322, in contrast, is activating progenitor cells in situ which have the "otic" fate already. I haven't seen any evidence thus far that any stem cell treatment ends up with cells in the cochlea that assume the otic fate and engraft to any degree whatsoever. The anti-inflammatory effects are possibly helpful, though and i don't see how they would preclude FX-322 from helping unless like I said, passage 1 cells can do what other cells don't seem to be able to.

 

[FGG]

Thinking about this more, it's possible this would help a synaptopathy even if it didn't regrow hair cells because synaptopathy responds to the Hough Pill (which has a powerful effect on Neuro inflammation and allows synapse reconnection).

As an alternative to stem cells, if someone has $100k to spare, they could actually get the Hough Pill made from a lab for themselves. @JohnAdams had looked into that once.

 

[FGG]

A new treatment on the horizon:

https://techtransfer.universityofca...tn_B_GyWiL8-RA7Um2zUnw3IIv0ia175KTHjiCe5PVkmg

Posted in another thread but relevant here. Statement about exosomes being useful for inflammation.

 

[all to gain]

Thinking about this more, it's possible this would help a synaptopathy even if it didn't regrow hair cells because synaptopathy responds to the Hough Pill (which has a powerful effect on Neuro inflammation and allows synapse reconnection).

As an alternative to stem cells, if someone has $100k to spare, they could actually get the Hough Pill made from a lab for themselves. @JohnAdams had looked into that once.

So do you know the exact amount of NAC in the Hough Pill? Justin said it was top secret.

If only there was only one less nought in that figure, I may be tempted...

 

[FGG]

So do you know the exact amount of NAC in the Hough Pill? Justin said it was top secret.

If only there was only one less nought in that figure, I may be tempted...

Nah, I don't have inside info on that but I bet if someone wants to call poison control they might know the toxic dose and then you could do a high dose well below the toxic dose maybe?