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Author Topic: Wake Forest- Good news  (Read 3461 times)

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hope794

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Wake Forest- Good news
« on: August 07, 2018, 06:24:44 PM »

Hi all.
In these days, i contacted Wake Forest University to know how their researches are going on.

I paste here to you the reply of Mrs. Mary-Clare:

Good afternoon Davide,

 Thank you for your interest in our research.

 We are about to begin a new clinical trial to replace damaged corporal tissue, primarily aimed at Peyronie’s Disease.  More information regarding the study, including inclusion and exclusion criteria may be found here:

 https://clinicaltrials.gov/ct2/show/NCT03463239

 If you would like to schedule a consult appointment with the urologist in charge of the study, the phone number is 1-888-716-9253.  The urologist is Ryan Terlecki.

https://www.wakehealth.edu/Faculty/Terlecki-Ryan.htm

It appears that you may not live in the United States.  Because this studies requires follow-up for 3 years after surgery, it is important that the enrolled patients live within 2 hours of the hospital.
Please let me know if I can provide more information to you.


Thank you,
Mary-Clare


Here you can see another response from a collegue of Mrs Mary-Clare: (Mrs. Bonnie Davis)
Please notice that Mary-Clare replied to my email after Mrs Davis.


HI Davide –

Thank you for your inquiry regarding the Institute for Regenerative Medicine’s research on penile tissue regeneration using cell and tissue engineering techniques. Although we are actively working in this area, our research is still in the experimental stage. We regret that this technology cannot be applied to clinical practice at this time, but there is hope for clinical trials in the near future. However, it is our goal to bring this technology to the point of widespread clinical use, and we hope to be able to help patients like you in the future.

We thank you for your interest in our work. We will keep your inquiry on record and contact you, if appropriate, in the future. (Please provide your full name, date of birth, address, phone number, and email so that we can contact you if needed.)

In the meantime, we encourage you to visit clinicaltrials.gov for the latest information on clinical studies related to your condition.

If you wish to seek any treatment for your condition in the meantime, we have a clinician in the Urology department who is an expert in men’s sexual health and Peyronie’s Disease.

Sincerely,
Bonnie Davis
Communication Manager
Wake Forest Institute for Regenerative Medicine
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24 yo from Italy.Peyronie's probably since 2014.Since then,penis bends of about 10-15°, with a slight twist to the left.Moderate Erectile Dysfunction since 2 years and things getting worse.From pornstar-like to moderately depressed,but still fighting for a solution.

tiagofil

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Re: Wake Forest- Good news
« Reply #1 on: August 07, 2018, 07:46:19 PM »

,
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Jack1909

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Re: Wake Forest- Good news
« Reply #2 on: August 08, 2018, 06:40:46 AM »

I spoke with Terlecki less than a month ago. I was there, in North Carolina. Well I was told that their priority focus are veterans.
I don’t why this Mary keeps on saying they are recruiting peyronies suffers as Terlecki told me they aren’t. So either I was not properly informed or this Mary is wrong. As far as I understood this Mary speaks just on Terlecki’s behalf...

I mean..something simply doesn’t add up. A trial just for veterns suffering from Peyronies Disease sounds improbable..
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Jack1909

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Re: Wake Forest- Good news
« Reply #3 on: August 08, 2018, 06:51:02 AM »

“primary objective of this Armed Forces Institute for Regeneration Medicine (AFIRM II) sponsored clinical”

...that’s what is written on the trial link
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swiss

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Re: Wake Forest- Good news
« Reply #4 on: August 08, 2018, 12:44:31 PM »

We aren't on the inside of a constantly shifting narrative in a structured corporate setting. I hope it changed and they shifted gears! haha.
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hope794

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Re: Wake Forest- Good news
« Reply #5 on: August 09, 2018, 10:01:13 AM »

Dear friends, i'm happy that this post has attracted your attention. Unfortunately, since i'm not mothertongue, i had the same doubts as Jack.
I thought that the clinical trial that Mrs. Mary was talking about was the penile transplant for veterans.
But i think that she was referring to a totally new experiment, so i did some research.

If i understood well, THIS is the clinical trial for total penile transplant of the brave veterans which lost their genitals:

https://clinicaltrials.gov/ct2/show/NCT03240822

Instead, this is the clinical trials for Peyronie's and other deformities and penile issues, the one which Mrs. Mary was talkin about:

https://clinicaltrials.gov/ct2/show/NCT03463239

As you can see, they are different. The second one, it's not so far - a primary completion date will be in 2021 and the final date is 2022. So, not really far, it's only 4 years to go. What i asked to Mrs. Mary is if, after this experiment, the treatment will be available for the clinics, or this is only a "Phase 1" which will be followed by a "Phase 2" and a "Phase 3", even if i don't think that because this is not a "drug" but a "treatment", it's already tested on "humans" and, if this trial will give good results, there will be no need to do further trials.

I would be really grateful if someone which is mothertongue or has a PERFECT english can give a comment about these. For an italian which don't speak english everyday it's not really easy to read scientifical papers and clinical trials and understand everything perfectly. Thank you really much!!
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24 yo from Italy.Peyronie's probably since 2014.Since then,penis bends of about 10-15°, with a slight twist to the left.Moderate Erectile Dysfunction since 2 years and things getting worse.From pornstar-like to moderately depressed,but still fighting for a solution.

Werther

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Re: Wake Forest- Good news
« Reply #6 on: August 12, 2018, 11:01:38 AM »

I've contacted WFIRM via e-mail several times since the beginning of this year and these are the last relevant information on their upcoming phase-1 clinical trial (at least, based on what I was answered after my iniquiries):

1) candidates' enrollment will begin in september;
2) candidates' enrollment could last "a couple of years";
3) once they'll have begun with the trial, it will last 36 months (follow up appointments included).

I'd also like to stress out that they don't intend to confirm that this intervention could solve Erectile Dysfunction, eliminate deformities or restore size; here's what I've been answered after I've asked them about these issues:

"Good afternoon,

The study procedure is not intended to help with Erectile Dysfunction.  It is intended to prove safety of this procedure and the feasibility of doing the biopsy and implantation of the cell coated scaffold to correct a small area of corporal defect.   I am not sure the procedure will solve your Erectile Dysfunction or restore size, but may correct some curvature, though we cannot say that since we are only approved by the FDA for safety results.

Regarding residency, subjects should live within an 2 hour drivable radius to participate in the study.

I  hope this information is helpful.

Thank you,

 
Mary-Clare
".
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AlexSamo

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Re: Wake Forest- Good news
« Reply #7 on: October 08, 2018, 09:31:00 AM »

1) candidates' enrollment will begin in september;
2) candidates' enrollment could last "a couple of years";
3) once they'll have begun with the trial, it will last 36 months (follow up appointments included).

So, "good news from Wake Forest" not as good as it's supposed to be? How long time will it take for all of these steps like patients enrollments, tests, safety approvals, FDA approval, etc.? 10 years? 20 years? More?
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james1947

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Re: Wake Forest- Good news
« Reply #8 on: October 21, 2018, 09:52:07 AM »

I will add my question to Alex question:
How many years after the trial (minimum 5 years) we will see results?
How many years later they will get approval from the FDA?
Legitimate questions, no?

James
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Werther

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Re: Wake Forest- Good news
« Reply #9 on: October 21, 2018, 12:59:51 PM »

I can't tell for sure, but if timings for phase-1 is at least 5 years (as it seems, based on their staff's words), I bet they'll take much more than a decade in order to get this surgery approved by FDA. And we can't even know as of today if this surgery will only be approved to treat curvature or if it will get approval even for Erectile Dysfunction.

Personally I have only one single question: what's the reason why this forum community has done nothing (and is still doing nothing) in order to communicate officially with WFIRM with regards to this trial?

It's pretty obvious that this kind of surgery can be beneficial only for guys like us and nobody is going to urge WFIRM to speed this process apart from us, because we're the only ones who might be interested. Except for the letter that was sent more than a decade ago to Atala, I've never seen anything done anymore as the "Peyronie's Disease Society". We have no right to complain about their slowness since we've been practically contributing to it.
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hope794

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Re: Wake Forest- Good news
« Reply #10 on: October 21, 2018, 06:22:14 PM »

I totally agree with Werther! In the past, i've done many posts about "doing something" but no one cares.

Guys, seriously, some days it seems that you don't have Peyronie's.

And please don't tell me that no one does nothing because of the "shame". I think that it's way more humiliating to have Peyronie's and, if the society needs some signature or donation to keep its activity, i would do it and i won't care to leave my real name on those papers, if it can help.

Why i don't do this on my own then? Simple: i'm only 24 years old, i come from Italy and i have a sh!^^y english; furthermore, i have no financial resources since i don't work and not enough knowledge about this disease since i discovered it only some months ago.

Good luck to everyone and please let me know if you're going to do something concrete - i'm always on, brothers.
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24 yo from Italy.Peyronie's probably since 2014.Since then,penis bends of about 10-15°, with a slight twist to the left.Moderate Erectile Dysfunction since 2 years and things getting worse.From pornstar-like to moderately depressed,but still fighting for a solution.

Alibaba

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Re: Wake Forest- Good news
« Reply #11 on: October 21, 2018, 08:21:15 PM »

I am familiar with HIV clinical trials having 2 friends that are researchers. 1 runs an entire research team.  Safety is always the first phase and a very narrow set of parameters to make sure nothing interferes with the trial. Very likely the safety phase will be be on individuals with no issues after animal phases have passed.  Each phase requires approval and in this case military review. That can add months between each phase. There is a review of the design of each phase and that can take months to write. Any issue can halt the program or trigger a complete redesign or rewrite of the project design. Both government, private party, and university financed trials are subject to financing. Someone cuts off the cash, it's over. Great strides are often made in medical science but it is a slow slow process.  Some program designs work excellent in animals or humanized animals but fall flat on their face in human trials, something I do not yet understand why and I have spent hours at a time discussing and bouncing theories back and forth with friends trying to figure out why. In the mean time, my suggestion is to to follow the trials wherever they go so you can share hope and ideas with others and if it is ultimately successful, share some more, but for those with issues here and now, go with the best currently available treatment you have at hand. Trials can often take 10 years or more. What shape will you be in 10 years of wait? What stress will you put yourself into to wait? Are you capable of keeping things in check without further deterioration to await the outcome of a trial?  I do not say these things to distress anyone but as being a person with a disease who has seen trial after trial start, fail, succeed, and promises of a cure never materialize in 30 years. Support every trial you can. Encourage the researchers. I know my researcher friends get very weary of the long hours they put into their projects and letting them know you appreciate what they do helps, but be realistic with yourself comparing the timetable of a trial and the timetable of your life. Cheers to men who strive to become boys again.
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Jack1909

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Re: Wake Forest- Good news
« Reply #12 on: October 22, 2018, 07:24:01 AM »

In my humble opinion, no one should loook at wake forest university work anymore...it will take forever before this will eventually be a available for everyone. They are focusing on military people, not us..that’s the prime reason why we should just turn around..
Anyway, phase 1, 2, 3 here works different than usual here as we are talking about a surgical procedure implying a grafting placed inside the body rather than a drug.

We might, as a group, find a research team placed in countries where people can go experimental if they want to..that’s might be a game changer. There is plenty of resaerchers from so many country which are working on tissue replacement and I would sign up immediately for any trial procedure which has got some reasonable background. Wake Forest doesn’t have any exclusive...
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hope794

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Re: Wake Forest- Good news
« Reply #13 on: October 23, 2018, 07:15:45 AM »

@Alibaba: thank you for your comment, it was great and i totally agree.

@Jack: unfortunately i think you're right. One day there will be a solution for Peyronie's disease, but i think we are still far far away.
For now, i would be happy if they find a solution for venous leak, since my main issue are the erections. My bend is about 10° so it's not an issue, but the Erectile Dysfunction for a 24years old guys is seriously the hell, a never ending curse.
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24 yo from Italy.Peyronie's probably since 2014.Since then,penis bends of about 10-15°, with a slight twist to the left.Moderate Erectile Dysfunction since 2 years and things getting worse.From pornstar-like to moderately depressed,but still fighting for a solution.

AlexSamo

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Re: Wake Forest- Good news
« Reply #14 on: October 23, 2018, 08:39:16 AM »

All of the comments in this thread are truly depressive and leading to suicide thoughts. What's the "good news"? The good news is to realise that it will not be possible for the nearest 30 years? Or good news in terms of: "The future generations of people will not have this problem as we face it now"? Oh well, this is a good news, right. But you forgot to add that most of us would be dead at the moment of time when the technology will be available. Name of this thread should be: "Good news for all who will be born after year 2050".
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Jack1909

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Re: Wake Forest- Good news
« Reply #15 on: October 24, 2018, 02:01:22 AM »

I don’t think it will take so long if we commit ourselves in finding "other places"...we should try, putting together our knowledge and our desire to see our life change....recently I put my eyes on Japan (as the result of its favorable legislation in terms of accessibility of regenerative treatments).

The point is...are you willing to sign up for an experimental procedure?? I would...

What baffles me is the fact we are talking about a tiny tissue structure replacement...there are people around the world involved in far more complex regenerative procedures...
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Werther

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Re: Wake Forest- Good news
« Reply #16 on: October 24, 2018, 03:18:57 AM »

Jack,

I agree with you on the fact that WFIRM has not any exclusive right on tissue engineering. This is not the main problem however. The fact is that we as a group don't do anything ever in order to communicate with researchers who might be working on something useful for us. That's why every developmental procedure (and there's very little for peyronie's disease or penile fibrosis more generally) takes literally ages to progress.

I'd be very glad to open up to other research groups but we should first know who they are. Could you please post a link here of the japanese's research team or others you know about that are dealing with penile erectile tissue bioengineering? Then, if we truly want to do something, I'd be very glad to get involved in any activity that could lead us to show our genuine interest (mass mail projects, donations or whatever). This is what should be done and PDS has never done it in the past. With regards to Atala, a letter was sent on the 23 of July 2010, it got no response and he wasn't solicited further (look here: Letter To Dr. Atala (Tissue Engineering) - Peyronies Society Forums); there's no wonder if they're only getting started by now (more than 8 years later!).

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hope794

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Re: Wake Forest- Good news
« Reply #17 on: October 24, 2018, 02:31:03 PM »

I agree with Werther. Furthermore, i would like to say that probably the people who are english mothertongue and live in USA have got more responsability in this matter, because they may take part of any experiment and have no troubles to communicate with scientists.
Personally, i asked to WFIRM if i could take part of the clinical trial, but they said to me that i'm too far away from them ( i think that you have to live near their research center, at a maximum of 2 hours of travel from them) and i could not partecipate since my english is not high level and i may have some troubles to describe with high precision to them any issue or symptom.

I've done EVERYTHING i could. I am trying a cure by MD Gianni Paulis, a doctor in Italy who says that he can ameliorate Peyronie's disease and, in some cases, let the plaque disappear. He says that i'm one of these cases..Let's see. I'll keep you updated.
Please, brothers from USA, do something!! As i said, if you need any support from other countries, like signatures for projects, or donations or anything else, i am sure that you'll find support from all over the world.
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24 yo from Italy.Peyronie's probably since 2014.Since then,penis bends of about 10-15°, with a slight twist to the left.Moderate Erectile Dysfunction since 2 years and things getting worse.From pornstar-like to moderately depressed,but still fighting for a solution.

Jack1909

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Re: Wake Forest- Good news
« Reply #18 on: October 25, 2018, 12:59:51 AM »

Yeah the fact we live abroad is a problem I was told the same...that’s  why I told them I would move to North Carolina LOL 
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AlexSamo

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Re: Wake Forest- Good news
« Reply #19 on: October 25, 2018, 03:13:07 PM »

It's seems like besides me and 3 Italian guys no one else is interested in this. What an irony: people who live on the other side of the Earth are interested in this more than someone who lives near NC or in NC.
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P1992

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Re: Wake Forest- Good news
« Reply #20 on: October 25, 2018, 04:55:25 PM »

AlexSamo,

I think many here have an interest and I am one of them, but we can not participate because we are excluded by the very rules of wake forest? In case the distance.
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Jack1909

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Re: Wake Forest- Good news
« Reply #21 on: October 26, 2018, 12:42:30 AM »

Yes Alex, that’s ridiculous...maybe American know how much Ugly NC is..LOL worst place I’ve seen in earth so far LOL
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TDix

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Re: Wake Forest- Good news
« Reply #22 on: October 26, 2018, 03:11:37 AM »

I’ve been following this, and I’ll say that even the manufacturer of Xiaflex, who found out about my problems, seem to not be interested in my reaction.  I have been waiting to talk with them but it’s been silent. I would hate to think that we are all a group that generates money at the expense of our well being for the drug companies/implant companies/VED companies/traction companies.  I just want a healthy d*ck man!  Seems a long way off for some of us
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Hawk

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Re: Wake Forest- Good news
« Reply #23 on: October 26, 2018, 08:22:29 AM »

maybe American know how much Ugly NC is..LOL worst place I’ve seen in earth so far LOL
:) I have been in more than a few countries and 35 states.  I pass through NC a couple times a year (probably well over 100 times).  I would rate it as a great state with beaches, cities, forested mountains, and a little something for everyone. 
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Werther

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Re: Wake Forest- Good news
« Reply #24 on: October 26, 2018, 08:40:23 AM »

I'm wondering: is there any US resident here who's willing to go down there and talk face to face with the people who's working on this trial in order to make things clear with regards to it and report to the forum?

If we can speak directly, we could clarify a lot of things, such as how long will the entire process (all phases of the trial) last approximately and if anyone can do anything to speed it up (solicit the government or anyone who's getting this thing funded, etc.). As long as we send e-mails, we'll never know anything concrete, since they basically dismiss all the important inquiries on the subject.

The fact than nobody seems to give a F~@< about this annoys the crap out of me and based on the previous posts in this thread it looks like I'm not the only one who feels like this.
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Hawk

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Re: Wake Forest- Good news
« Reply #25 on: October 26, 2018, 09:04:43 AM »

It seems like a phone call would be just as productive.  I have not followed this closely since it involved studies that will either succeed or fail many years in the future.  I personally doubt that any of this is slowed down by a lack of volunteers.  These things are painfully slow for reasons Alibaba pointed out.

If these people are willing to talk, I am happy to call them.  In fact I think we had a member of our PDS team that was in contact with them many years ago and who visited them in person.

Before I would attempt to contact them I need to understand the issues and a clear set of questions.  I also pass near that area a couple times a year but as I said, I think phone calls would accomplish as much as a visit.

PS: i think one has to consider current proven solutions.  I consider the implant in my penis a far far more important issue than something that has only a chance at success that will not be known for over a decade.  To anyone with Erectile Dysfunction, there is a great solution now.
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Werther

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Re: Wake Forest- Good news
« Reply #26 on: October 26, 2018, 12:49:55 PM »

Hawk,

I got Alibaba's point and I agree with him, but I have to agree with Jack too: this trial is about a surgical procedure and my thinking is that there should be less obstacles and less time to spend to complete the whole procedure compared with trials whose goal is to test drugs... In this case there will be no control group after phase 1 if it's successful and this is for example a single reason why it should be quickier than trials dealing with drugs (I think that with regards to the latters, timespans could be longer because during the process researchers could reconsider dosages, composition of the drugs and lots of other variables that don't come up with surgical procedures).

Anyway, I keep thinking that being there in person and talking face to face with anyone who might answer what's relevant would be way better than talking on the phone. I speak by personal experience: I had trouble lots of times while contacting hospitals via phone... Once the person you're looking for is not avalaible, then some questions can't be answered by the person you're talking with, because you'd have to speak with colleague who isn't avalaible at the moment, etc. It's easy to be dismissed this way, even if the communication is clearly more direct than the one you can have via e-mail.

However I really appreciate your offer and if nobody is willing to go there I'd like you to call them to ask them some precise questions (better than nothing). If anybody here would like to submit what they want to ask them, we could form some sort of list and then you can report back to us what answers you received. Let's see if others here agree with this.
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suicidecomingsoon

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Re: Wake Forest- Good news
« Reply #27 on: October 26, 2018, 01:13:29 PM »

Jack was there in person, it will be a long time before something from this institution can help us.
As Jack said it is better to look elsewhere, this looks like it will take 10-15 years to reach some conclusion, maybe 20 to be available if it comes out ok


This has been discussed for almost 10 years in this forum, at that time they could re-create cavernous bodies, spend another ten years and the thing will not have advanced much I suspect

In 2010:

"Hey Guys – My name is Ken and this is my first post on the site. I'm 48 years old and was diagnosed with Peyronies in 1989 therefore I'm encouraged by some of the advances that are on the horizon such as tissue regeneration. Tissue engineering technology is here today! The technology exists today to fabricate and replace a complete corpora cavernosa using your own cells thus eliminating any tissue rejection issues. I base my statement on the following:

1.  Dr. Atala and his team from Wake Forest Institute for Regenerative Medicine has fabricated and surgically implanted functional Corpora Cavernosum into rabbits. The corpora cavernosum were generated by building a scaffold and spraying the scaffold with the smooth muscle and endothelial cells, and then allowed to grow. The new rabbit penises are functional and operated well.
2.   Dr. Atala’s team has been surgically implanting functional bladders into humans for the past four years, thus reducing some of the learning curve associated with human subjects and tissue engineering.
3.   Dr. Badylak from the McGown Institute of Regenerative Medicine has a different approach to regenerating body parts. His team uses a substance called ECM, Extra Cellular Matrix, extracted from pig bladders. The substance is places on the injured body part and it provides signals and instructions to jolt the cells into regenerating themselves. Amazing"


I think, maybe it's not a bad idea to contact to Dr. Badylak instead Atala?
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Re: Wake Forest- Good news
« Reply #28 on: October 26, 2018, 01:19:38 PM »

Thanks for the post to put this in perspective.  I recall this for almost as long as we have had a forum and though I have not followed it in the last few years my impression was that we are not much further along.
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Jack1909

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Re: Wake Forest- Good news
« Reply #29 on: October 27, 2018, 07:37:26 PM »

I did my very best to get some insight into the matter but I was rejected and I couldn’t grasp all the info I’d like to. They weren’t so open up on it and honestly I don’t want to be involved with anything having to do with wake forest anymore. I wasn’t treated the way a person coming from the other part of the world would expect...anyway, Terlecki is the principal investigator of these trials, but you might need to arrange a consultation to have the chance to get in touch with him...

My hope is that the technology will spread soon in countries in which if you want to go experimental you are free to do it. Wake forest can go to hell...

Comment on implants moved by the Administrator with a long string of off topic implant posts.
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Alibaba

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Re: Wake Forest- Good news
« Reply #30 on: October 29, 2018, 11:46:52 AM »


Dont you think is logically, if not medically, correct to me exploring every single option

Logic says 2 important things.

1) Most of these experiments go on for decades before available to the public and many are unaffordable or covered by insurance for a time after that.

2) Time wasted (waiting) equals lost function, pleasure, length and progression of disease.

Support all research. Encourage your researchers. Use logic and be realistic.
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AlexSamo

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Re: Wake Forest- Good news
« Reply #31 on: November 01, 2018, 09:06:21 AM »


It's pretty obvious that this kind of surgery can be beneficial only for guys like us and nobody is going to urge WFIRM to speed this process apart from us, because we're the only ones who might be interested.

I have to disagree with you on this. You think only people with Peyronies Disease will have benefit from this? Let me list other "groups" of people which are waiting (and need it) not less than we are:

1. People with Peyronies Disease (obviously)
2. People with erectile dysfunction
3. People with micropenis
4. People with small penis (not micropenis but smaller than statistical norms) who wants (and who have medical reasons for this) to increase size of the penis, but they can't do this because there are no legit procedures at the present time
5. People with injured/damaged penis
6. People who underwent invasive surgeries such as radical prostatectomy and other similar surgeries
7. People with penile/cavernous fibrosis
8. People who were born with epispadias/hypospadias and other inborn penile defects.
9. People after total penile amputation due to different reasons (injury, cancer, etc.)
10. Transsexual people (FtM), but I'm not sure if they will able to have such procedure because they originally don't have specific cells in their bodies.

That's not all "list" I guess. There are probably many others who will have benefit and who wait for this technology while having no alternative options at present time.

P.S. I don't get just one thing. This project of "penile tissue engineering" (or experiments, tests, trials, or whatever it's called) now is close to 30 years mark. Is this not enough time for creating something?! If they keep doing this work so slow, it will definitely reach a 50-year mark. Half-century for just one subject?! Even things like atomic reactors and space flights have taken much smaller timeline for humanity than creating a small pieces of penile tissues. This is ridiculous.
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hope794

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Re: Wake Forest- Good news
« Reply #32 on: November 01, 2018, 09:53:20 AM »

I totally agree with Alex. As i said: if any english-native speaker (better if american) wants to begin seriously to do something, i'm totally ALL-IN.
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Re: Wake Forest- Good news
« Reply #33 on: November 01, 2018, 11:09:42 AM »

At one time we had a couple men who volunteered and worked exclusively on Public Outreach and Awareness.  It was a very adventurous plan for a loosely knit volunteer group.  We had so much going on that I an others worked huge amounts of their days.  I seldom got out of reach of the PC or iPad in those days.  It was not uncommon to put in 18 hours on Peyronies Disease issues.  Maintaining that level with casual volunteers is not easy.  People burn out and go their way.  Over the many years, I have worked with great men and women.  Some had connections in the right places, many had great skills, they all had a desire to serve others but they also had other life issues that pulled them away. We try to replace them but the challenge requires finding the right match.  It is not easy to find someone with the 1. people/professional skills, 2. Passion, and 3. the time to do what is necessary.  We have many people with one or two of those but it takes all three. 

I no longer have the time to stay at the keyboard day in and day out.  That makes it difficult to recruit others that are willing or able to do that. 
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Werther

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Re: Wake Forest- Good news
« Reply #34 on: November 01, 2018, 05:28:55 PM »

It takes very little time and no money at all to sign up a petiton. This is my opinion at least.
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Re: Wake Forest- Good news
« Reply #35 on: November 02, 2018, 05:51:31 AM »

I personally don't feel like having attacked anyone, staff members included. Unless you think that it's an attack asking for an opinion about a petition or anything that could spread awareness or help speeding up trials that could be useful for every man with penile fibrosis and Erectile Dysfunction, but I don't see what would be the logic behind such a statement.

To answer directly your question, I'd personally try my best to get involved in this phase1 trial that is about to begin in the very next few years (no decades, just a couple of years at worst), but I won't do it since the main investigator didn't intend to confirm in any way that this first intervention could be beneificial for Erectile Dysfunction. Based on this assumption, I'd like to wait for the results of this first phase and then do the best I can in order to get involved in phase2 if good results will be reported from the previous one. And I won't have to wait for 15 years at the very least in order to get these things done. Maybe I wouldn't have to wait for 5 years neither if we could make ourselves being heard by these people. Hence I'd appreciate very much if we'd actively do something on this front and that's why I've talked about petitions and advocacy in my last posts. You're right on one point though: this Wake Forest experiment might even not work, but won't there be an implant as a last resort if this surgery failed as everybody say? If so, why bother on some people's choice to try something experimental before getting the life (non reversible) decision to get implanted?

With regards to the denial's rant let me just say that it's not a problem of mine. I know how things are with regards to Erectile Dysfunction and everybody does (even wikipedia is sufficient for this kind of info)... Then, I don't mean no offence but you've been aurond here and other Erectile Dysfunction forums for years and you've always looked comfortbale with implants based on your posts, so why didn't you get one and you're still not getting it? It looks like you're the one living in denial rather than me or others here...
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Re: Wake Forest- Good news
« Reply #36 on: November 04, 2018, 02:04:50 PM »

I split off all the all the posts on the implant debate and moved them to the implant topic of the Erectile Dysfunction forum.  Here is the link for any interested.


Wake Forest- Vs Implant - Peyronies Society Forums
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Werther

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Re: Wake Forest- Good news
« Reply #37 on: November 11, 2018, 04:21:46 PM »

@everybody: Hawk kindly offered himself to go to WFIRM or call them via phone to ask them any relevant question that might clarify things we don't know about this trial. I have some questions and I'm going to post them here. If anyobody else would like to ask something else, he can do it right here.

Here are my questions:

1. Why does candidates' enrolment for this phase-1 study has to take at least 2 years? What's the reason behind this choice? Is it like this because of the FDA or is it a WFIRM's personal choice? Can anyone do something about it in order to reduce the timeline expected for closing candidates' enrolment for this phase of the clinical trial? If so, what can be done concretely?

2. Will WFIRM confirm that their experimental surgery aim to solve Erectile Dysfunction, deformities, curvature and size loss that are linked to peyronie's disease or, more generally, erectile tissue's fibrosis? If they don't intend to confirm it with regards to their phase-1 study - since it's only a safety study - are they going to confirm it at least for phase-2? In other words, what's the aim of the whole trial? Do they want to solve any side effect of erectile tissue's fibrosis with their intervention (Erectile Dysfunction and shaft's deformities included)?

3. What about the "whole penis development"'s project? WFIRM announced to the media that they were able to create "half a dozen human penises" back in 2014 (here's the link: https://www.theguardian.com/education/2014/oct/04/penis-transplants-anthony-atala-interview) but they're taking forever just to replace small parts of erectile tissue? Will they ever be able to bioengineer the whole organ? And why did they say that they've already done it in the lab? Is it true or was it just some fake news made up for the press?

4. Does WFIRM have an approximate timeline with deadlines for the whole trial? Can they estimate when will they begin phase-2 and phase-3 and when they'll be completely finished with this?

That's all for now. I'll add something new if I'll come to think about it.

@Hawk: I don't know if this post belongs here or if it deserves its own thread: please move it on a new thread if you think it's necessary.
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james1947

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Re: Wake Forest- Good news
« Reply #38 on: November 13, 2018, 02:07:37 AM »

Good questions Werther :)
Hope they will be willing to answer them.
They didn't answer my questions some 5 years ago.

James
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Re: Wake Forest- Good news
« Reply #39 on: November 15, 2018, 12:30:50 PM »

@everybody: Hawk kindly offered himself to go to WFIRM or call them via phone to ask them any relevant question that might clarify things we don't know about this trial.


Werther, thank you. Special thanks to Hawk.

Well, I have a lot of questions, but one question is the most important.

Here's my question to Wake Forest: How many years will it take for all of the tests, trials and approvals before this technology finally will be available in clinical practice? Is there something like approximate timeline, like 5 years, 10 years, 20 years? That's my only question. Thanks.
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Re: Wake Forest- Good news
« Reply #40 on: November 30, 2018, 04:41:29 PM »

I made an email contact with Wake Forest 4 or 5 years ago with no response.  I intend to be a little more persistent this time.

Does anyone on the forum have any contacts there, or can anyone give me any information that might help me reach a useful contact a little more quickly? If not I will call the main number and start from there although that is less likely to be very efficient or productive, I assume I will start with the Wake Forest Institute for Regenerative Medicine (WFIRM) rather than the urology department. 
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Werther

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Re: Wake Forest- Good news
« Reply #41 on: December 01, 2018, 10:03:26 AM »

I think you should call Mary-Clare Day (the Research Nurse Manager who poses as a referral for this trial): her number is 336-713-1343 (source: https://clinicaltrials.gov/ct2/show/NCT03463239). The main investigator of the trial is Dr. Ryan Terlecki and the sub-investigator is Dr. James Yoo but unfortunately I couldn't find any phone contacts of these but I have Dr. Terlecki's personal secretary (Pam Gippert)'s phone number and perhaps it might be worth calling her too: her number is 336-716-5690.

Anyhow I'd like you to ask them a few more questions in addition to the ones that I posted before (i'm formulating these via progressive numeration considering the previous ones):

5. What kind of adverse events do they think can happen with this experimental procedure? Are they able to provide a full list of possible adverse events?

6. What are the causes of the constant delays of their trial? I was once told by Ms. Day that they had to begin with enrolment last May, then - after another email's contact - she told me that they would have begun enrolling people by June or July; now I'm reading on clinicaltrials.gov that they're not recruiting yet. What's the reason for this? When are they finally going to recruit candidates?

Thank you for your help.

I hope to see some updates.
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Re: Wake Forest- Good news
« Reply #42 on: December 01, 2018, 11:13:49 AM »

Werther,

In preparing for this contact I think we have good questions and a good start on initial contact info.  Thanks for your help.  This week I watched some clips of Dr. Terlecki and Dr. Atala that I had not seen before.  I would think Dr. Atala's office would also be a good possible contact.  Is there a reason you did not mention him?

Also, you mention your prior contact with at least Ms.Day.  Did you mention the forum at that time?  How were you generally received what was the reason you had no further contact?
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Werther

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Re: Wake Forest- Good news
« Reply #43 on: December 01, 2018, 12:56:44 PM »

I did not mention this forum any time I contacted them ever. I always asked questions on my behalf. I'd be glad if you'll make clear to them that you're reaching out to them as a representative of a group (this forum). This way we could maybe get more understanding and consideration.

I had no further contact with Ms. Day because I was practically told to get there in person to get evaluated in order to estabilish my possible eligibilty for the trial. Besides, I only spoke with her via e-mail since I don't live in the USA. I'd rather have called them or been there in person by myself if I lived in the United States. Unfortunately I don't and that's why your offer to get in touch with them more directly is greatly appreciated. At least from my point of view.

I thought about getting in touch directly with Atala too, but he's not mentioned in the record that Wake Forest submitted on clinicaltrials.gov. Besides I don't have any contact of his (except for his office's e-mail: I once wrote to that account but I didn't get any response back). He could may well be a good contact, since he appears to be the guy who first thought about the concept that stands behind this clinical trial, but I don't know how can you directly talk to him.
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AlexSamo

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Re: Wake Forest- Good news
« Reply #44 on: December 01, 2018, 02:21:39 PM »

Wake Forest's secretary M.C.Day: mday@wakehealth.edu


Other Wake Forest's secretary: tbowen@wakehealth.edu, krchrdsn@wakehealth.edu, marbeck@wakehealth.edu


Dr. Ryan Terlecki: Ryan Terlecki | Profiles RNS (email: rterlecki@wakehealth.edu, phone number: (336) 713-4131)


Dr. James Yoo: James Yoo | Profiles RNS (email: jyoo@wakehealth.edu, phone number: (336) 713-7294)


Dr. Anthony Atala: Anthony Atala | Profiles RNS (email: aatala@wakehealth.edu, phone number: (336) 716-5701)


Wake Forest Department of Urology Research: https://school.wakehealth.edu/Departments/Urology/Urology-Research


Wake Forest Institute for Regenerative Medicine (WFIRM): https://school.wakehealth.edu/Research/Institutes-and-Centers/Wake-Forest-Institute-for-Regenerative-Medicine
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AlexSamo

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Re: Wake Forest- Good news
« Reply #45 on: December 05, 2018, 12:22:35 PM »

Werther,
Hawk,

I hope this information will be helpful
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Re: Wake Forest- Good news
« Reply #46 on: December 05, 2018, 02:40:20 PM »

Ayala is soemoene who can’t be reached out, he’s a like a vip or as if you wanted to speak with the president of US.

Marie Whatever said you to come and be assessed just to get some money out of you. There is no chance to be envolved in any of the trials they proprose.

In the meanwhile, in Japan this December the first spinal cord regnerative treatment will be available for everyone. Kind of funny .
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hope794

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Re: Wake Forest- Good news
« Reply #47 on: December 06, 2018, 06:53:20 PM »

Hello guys, any news?
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Re: Wake Forest- Good news
« Reply #48 on: Today at 03:36:02 PM »

I called both  Mary-Clare Day (the Research Nurse Manager who poses as a referral for this trial) and Dr. Terlecki's personal secretary (Pam Gippert) today and left a voicemail for each of them.  Hopefully, I will have live contact sometime this week.
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