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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 if  the
    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!