I have had trouble talking live to anyone (that could answer questions) on numerous attempts. I am encouraged that they did try to call me once but I missed the call.
Here is some email information that I received from Mary Claire-Day. This is part of an email that included my questions and their response in red font..
1. Can WFIRM confirm that the eventual goal of this study is to resolve
erectile dysfunction, deformities, curvature, and size loss that are linked to Peyronie's Disease or, more generally, erectile tissue's
fibrosis? If you don't intend to confirm that with regards to your phase-1 study - since it's only a safety study - is it your goal to confirm it at least for phase-2? In other words, what's the aim of the whole trial? Is it to solve erectile tissue's
fibrosis and resulting side-effects?
THIS IS A SAFETY AND FEASIBILITY STUDY AND WE HOPE TO MOVE ON TO A PHASE 2 FOR OTHER INDICATIONS THAT REQUIRE REPLACING CORPORAL TISSUE2. Why does candidates' enrolment for this phase-1 study have to take at least 2 years? What's the reason behind this? Is it like this because of the FDA or is it a WFIRM's choice? Can anyone do anything to reduce the timeline expected for closing candidate enrolment for this phase of the clinical trial? If so, specifically what can be done? Can we help?
WE ARE REQUIRED BY THE FDA TO STAGGER ENROLLEMENT – WE ARE REQUIRED TO WAIT 3 MONTHS IN BETWEEN PATIENTS TO ENSURE THAT THERE ARE NO ADVERSE EVENTS. THE FDA ALSO REQUIRED THE 3 YEAR FOLLOW-UP PERIOD3. 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 [theguardian.com]) but it is taking many years just to replace small parts of erectile tissue? Will you ever be able to bioengineer the whole organ? And why was there a report that you did this in a lab years ago? Was this accurate or was it simply hyped media reporting?
WE ARE REQUIRED BY THE FDA TO SHOW SAFETY IN STEPS (CORPORA, URETHRA) BEFORE WE MOVE FORWARD WITH A WHOLE PENIS SURGERY. I DO NOT HAVE ANY MORE INFORMATION THAN THIS4. What kind of adverse events do they think can happen with this experimental procedure? Are you able to provide a full list of possible adverse events?
I AM HAVING TROUBLE SENDING ATTACHMENTS WITH MY EMAIL BUT WILL TRY TO SEND YOU A COPY OF THE CONSENT FORM SO THAT YOU CAN SEE THE POTENTIAL ADVERSE EVENTS – THE LIST OF ADVERSE EVENTS WAS ALSO, IN PART, DICTATED BY THE FDA Guys, See the "RISKS" document that I attached below these questions
5. What are the causes of the constant delays with this trial? a member reports he was once told by Ms. Day that they had to begin with enrolment last May, then - after another email's contact - she reported they would have begun enrolling people by June or July; now we read on clinicaltrials.gov [clinicaltrials.gov] that you are not recruiting yet. What's the reason for this? When are actually going to recruit candidates? Can we help?
THE DATES WERE ESTIMATES – WE HAVE BEEN WAITING FOR ALL ADMINISTRATIVE APPROVALS TO BEGIN AND ARE NOW WAITING FOR OUR LAB TO TELL US WE CAN BEGIN. I HAVE BEEN TOLD THAT WE SHOULD BE ABLE TO RECRUIT STARTING IN FEBRUARY, BUT I AM AT THE MERCY OF THE LAB
6. Does WFIRM have an approximate timeline with deadlines for the whole trial? Can you estimate when you will begin phase-2 and phase-3 and when you will be completely finished with this? How many years will it take for all of the tests, trials, and approvals before this technology finally will be available in clinical practice? What is the most optimistic hope for availability to the patient (5 years, 10 years, 20 years)? (We ask because men are actually delaying implant and other surgeries in the hope that this will become available as a better solution.)
NO WE DO NOT HAVE A TIMELINE. IT MAY TAKE UP TO 5 YEARS TO COMPLETE THE PHASE 1 WITH THE 3 YEAR FOLLOWUP INCLUDED. WE PLAN TO SUBMIT THE PHASE 2 TO THE FDA PRIOR TO THE COMPLETION OF ALL THE FOLLOW-UP. ANY FUTURE STUDIES WILL BE MULTICENTER SO THAT ENROLLMENT MAY BE QUICKER_____________________________________________________________________________________________________________________________________________
What Are the Risks of the Study? Being in this study involves some risk to you. You should discuss the risk of being in this study with the study staff. It is important to note that if you take part in this study and experience an adverse event, it may limit or eliminate the possibility of having a future treatment or surgery for that condition because of infection or deformity.
Risks and side effects related to the biopsy and corpora cavernosa construct treatment that we are studying include (but are not limited to):
Anesthesia Risks
Your will be placed under conscious sedation (made very relaxed and/or sleepy with medication but not put completely to sleep) and/or general anesthesia (put completely to sleep with medication) twice - once for the biopsy and once for the corpora cavernosa construct implant procedure. If you were not enrolled in this study, and underwent the current standard of care surgical treatment, you would also receive anesthesia once as part of that treatment. While under anesthesia, you could have difficulties breathing requiring emergency care to help you breathe, or she could have serious cardiac dysrhythmias (abnormal heartbeats), changes in liver, nausea, vomiting, itching, stroke, or suffer brain damage or death. These are complications that can occur with any operative procedure. Dr. Terlecki, or a member or the study team, will discuss with you these general surgical and anesthesia risks. These risks will also be explained before your surgery in a separate consent form provided by Wake Forest Baptist Health that you will be asked to sign. A copy of that consent form will be placed in your medical and study records.
Risks Associated with the Biopsy and Implant Surgeries
· Pain, bleeding that is hard to stop, infection at the site of the biopsy and/or the corpora cavernosa construct implant.
We may not be able to obtain the corpora tissue/cells from the biopsy due to unexpected and unforeseeable (not currently thought of) technical reasons, the cells may not become part of the scaffold as expected or at all, or the implanted corpora cavernosa construct may fail and have to be removed. If any of these occur, you may choose to receive standard of care surgery or other options at a later date.
Potential risks that are similar to the standard-of-care penile
prosthesis implant procedure include:
pain which may be temporary or long term
infection which could require antibiotics and/or result in loss of penile tissue and/or the construct implant
damage to surrounding tissue (blood vessels, nerves, muscles) requiring immediate or delayed surgical repair
injury to the urethra, urethral stricture and/or abnormal voiding which may require temporary or permanent catheter
penile abscess or fistula formation which would require additional surgery and possible catheter placement
injury to the rectum which would require additional corrective surgery
continued or worse
erectile dysfunction which may require medication or another surgery
penile curvature which may require surgery or may not be able to be corrected
Blood Draw RisksPain, bruising, bleeding that is hard to stop, infection at the site from which the blood is drawn, and fainting may result from the blood draws at any of the visits.
X-Ray/Radiation Risks
Exposure to x-rays if you have the chest x-ray at screening .You will be exposed to amounts of radiation above what you would normally receive in daily life. To be sure that you do not receive an unhealthy amount of radiation from participation in this study, you should let the study doctor know if you have had, or are going to have, any other scans or x-rays as part of your medical or dental care. It is very important that you let the study doctor know if you are already participating in, or plan to participate in, any other research study that involves radiation exposure.
Risks Associated with the ScaffoldBecause the cells used on the scaffold will be your own (also known as Autologous), we do not expect any bad reactions that could occur if someone else’s cells would be used (also known as Allogeneic), but there is always a small risk of an allergic-type reaction which may lead to the need for the implant to be removed.
There is a risk of infection from bacteria and other disease causing agents that may be accidentally introduced during the process of creating the scaffold/construct. The entire procedure will take place within the sterile environment so this is not expected.
There is a risk that any improvement in function that you may have following the treatment may not be permanent. Some of the early studies that were performed in rabbits have shown that penile function improvement began to fade after about 6 months.
Confidentiality Risk
There is a slight risk of a breach of confidentiality. Taking part in this research study may involve providing information that you consider confidential or private. Efforts, such as coding research records, keeping research records secure and allowing only authorized people to have access to research records, will be made to keep information safe.
Other RisksThere also may be other side effects that we cannot predict. You should tell the research staff about all the medications, vitamins and supplements you take and any medical conditions you have. This may help avoid side effects, interactions and other risks.
A Data Safety and Monitoring Committee, an independent group of experts, will be reviewing the data from this research throughout the study.
Other Issues to Participating in Research
As part of this study, you will be tested for HIV (human immunodeficiency virus, which is the virus that causes the acquired immunodeficiency syndrome [AIDS]); Hepatitis B and C, and other infectious blood diseases/viruses. You will be told of the results of the testing, and counseled as to the meaning of the results, whether they are positive or negative. If the test indicates that you are infected with any of these diseases, you will receive additional counseling about the significance of your care and possible risks to other people. We are required by law to report all positive results of these tests to the North Carolina State Board of Health. The test results will be released only as permitted by applicable law. If you do not want to be tested for HIV, Hepatitis B or C or other infectious diseases, you should not agree to participate in this study. If any of the tests are positive, you will be excluded from the study.
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Topic: Wake Forest- Good news (Read 17334 times)