A Novel And Innovative Method To Inject Plaques of Peyronies Disease
Local therapy (intralesional injections) offers the theoretic advantage of targeting therapy directly into the Peyronies plaque, which would permit higher does and decrease the possibility of systemic adverse reactions.
There are 3 factors in successfully treating Peyronies with intralesional injections. The right substance is required, the appropriate plaque area must be located and the treating substance must be properly delivered into the plaque. For many men in the chronic phase of the disease, the last factor proves problematic because the plaque area has become hard or in even more extreme cases, calcified. The manual power of the injection may not be effective enough to penetrate hard or calcified plaque. This presents a significant problem in treating men in the stable phase of Peyronies. For example, calcified plaque was a disqualifying factor for the Xiaflex clinical trials.
An Israeli scientist writing in the Journal of Urology came up with a simple method to inject the medicine into dense plaque. It seems so logical that you have to think why didn't someone think of this before. This physician adopted a simple inflation device commonly used in other surgical fields to improve the injection force. He then mounted a needle onto the inflation device.
This is what an off the shelve version of this device looks like before the needle is attached.
This is an illustration of what the device looks like when the needle is attached to the inflation device.
Eight patients at this clinic who were being treated for Peyronies Disease with intralesional injections were selected for use of this device because it was determined that a manual injection did not have enough force to penetrate the hard plaque. This is an extremely small sample, but none of the men experience any significant adverse events.
In addition to the ability to penetrate hard plaque this device offers a number of other additional advantages. After one injection, the piston of this device can be rotated and another area of the plaque can be injected avoiding repeat penetration of the skin. Secondly, these devices have a pressure meter. Once the urologist determines the most effective pressure to penetrate the plaque, he can quantify it by noting this on the pressure meter. It will be much easier to precisely duplicate this most effective effort at the next treatment session.
One final observation. At you will note in the illustration of the inflation device, the injection is being given needle facing upward. I have had many intralesional injections. First with Verapamil, then a placebo and finally with Xiaflex. Each and every injection had the needle facing downward into the penis. I have never seen the needle position as seen in this illustration. This may be for illustration purposes only, but at least based on my experience, it is a novel angle of injection. And maybe a safer approach not yet practiced by many physicians in the United States?
I suggest that any man undergoing intralesional injections discuss this approach with his physician.
Regenerative Medicine and Peyronies Disease
Stem Cell/Regenerative medicine will ultimately be the cure for our disease. Unfortunately, this all take a great deal of time for this approach to move through the testing and regulatory process. A company by the name of Cell Surgical Network is beginning a phase 1 clinical trial for a wide range of diseases, including Peyronies Disease. This organization has participating physicians all across the United States and there may be one near you. It is a very positive step that some physicians have FDA approval to go ahead and begin testing stem cells on men with Peyronies. The only medical proof needed for participating is a physician's note with a diagnosis of Peyronies Disease. Their approach will be stem cell injection(s) into the Tunica Albuginea along with Low Intensity Shock Wave Therapy. However, there are some not so favorable aspects to this trial. Note: That I contacted the physician at the Network and he supplied the fee amount to via email.
A phase 1 trial's primary purpose is not to make up better. It is see ifthe treatment approach will cause you harm.
This is a patient funded clinical trial. The charge to the patient is $7500
plus room and board.
If you want further information about this clinical trial click on CLINICAL TRIAL and if you want further information about this organization click on CELL SURGICAL NETWORK.
Here is their poster from the 2013 American Urologic Association Western Division - Partially Reproduced.
AUTOLOGOUS ADIPOSE DERIVED STROMAL VASCULAR FRACTION COMBINED WITH LOW INTENSITY SHOCK WAVE THERAPY FOR THE TREATMENT OF PEYRONIES DISEASE-A PILOT STUDY
Elliot B. Lander MD, Mark H. Berman MD, Jackie R. See M.D. INTRODUCTION: We evaluated the safety and efficacy of deployment of SVF Stromal Vascular Fraction (rich in adult mesenchymal stem cells and growth factors) combined with Low Intensity Shock Wave Therapy for the T reatment of Peyronies Disease in four patients. Autologous SVF can be easily obtained from adipose tissue lipoaspirate and is known to contain adult mesenchymal stem cells in high numbers as well as numerous cytokine growth factors. Regenerative cells in SVF can be activated by cytokine signals released from tissue that is diseased, damaged, or inflamed. Low Intensity Shock waves create controlled micro-trauma that is expected to be able to mimic these conditions and activate the stem cells through cytokine release to signal repair. SVF can be procured and deployed within a few hours in the operating room as a type of lipo-transfer procedure.
CONCLUSIONS: Intracavernosal deployment of SVF in a small group of Peyronies disease patients can decrease curvature and improve sexual function in short term follow-up. Shock wave therapy may contribute to disruption of Peyronies plaques providing an opportunity for improved healing associated with the introduction of procured mesenchymal stem cells in extremely high numbers from autologous SVF. Cell based therapies in conjunction with low intensity shock wave therapy may have a role in the treatment of Peyronies and further studies are needed to determine long term results, shock wave settings, intervals and timing of SVF deployment.
METHOD: Five men (ages 45-66) with documented chronic stable Peyronies disease associated with erectile dysfunction were selected. After IRB approved consent, Mini-liposuction (50cc) was performed. A closed system (TimeMachine™ by MediKhan) device was used for SVF procurement. Patients underwent Low Intensity Shock Wave Therapy to the penis on the day of SVF deployment and treatments were also performed 48 hours prior and after SVF. SVF was deployed by intracavernosal injection into the plaques. Patients were evaluated using PDQ Peyronies Disease Questionnaire and EHGS scores at baseline and at 3 months.
OBJECTIVES: Clinically significant improvement over baseline was seen in all 5 patients at 3 months. There were no adverse events. All patients noted subjective improvement in curvature, reduction in plaque size, and improvement in erectile function. EHGS mean scores increased from 2.0 to 3.6 at three months. All five patients Peyronies Disease Questionnaire scores decreased from mean 29.0 to 11.4 at 3 months.
Note that EHGS refers to erect penile hardness.
While we are on the topic of stem cells I received the following unsolicited email.
comments = My name is Dr. Alejandro Caldevilla
We are using stem cell treatments at our clinic in the Dominican Republic. We use adipose tissue and other sources. Placenta and umbilical chord. We use hematopoietic cells for plasma rich implants. We have had success in sports medicine and other pathologies.
We will be glad for referrals on implants for pyronies. if you should like to inquire of our clinic.
My direct # 829-632-6466
Bella Forma Calle 15 # 1-3 Los Jardines Metropolitanos Santiago, Rebublica Dominicana
Our staff of physicians have over 15 years of research and experience in stem cells. The patients will have excellent care and noticable results using this safe procedure. We treat patients from MLB, NFL, NBA, and local professional sports clubs. We will be glad for you to contact patients who have been treated successfully over the years by our professional staff.
My comment - You should at least learn to spell Peyronies!