Prospective, open labeled, non-randomized, study to be conducted at a single center. Ten
subjects will undergo an injection of Placental Matrix-Derived Mesenchymal Stem Cells
(PMD-MSCs) into the penis for the treatment of Peyronie's Disease. Follow up visits will be
conducted at 6 weeks, 3 months, 6 months, and 12 months. Subjects will be eligible for
re-injection at 3 months and/or 6 months as determined by the clinician based on patient
reported treatment satisfaction.
Symptoms of Peyronie's disease include penile pain and curvature of the penis that prevents
penetration and/or causes erectile dysfunction (ED). It is characterized by plaques that
form along the top or bottom side of the penis inside the tunica albuginea; the plaque
begins as a localized inflammation then develops into a hardened scar. Cases can range from
mild to severe. In several cases, the hardened plaque reduces flexibility, causing the penis
to curve during erection. The sexual problems as a result can lower a man's self-esteem and
interfere with a couple's physical and emotional relationship.
The cause is unknown; however, possibilities include trauma, inherited conditions, Vitamin E
deficiency, diabetes, and vascular disease.
Conservative treatments used in the acute phase (initial onset of symptoms) include oral
therapies. Vitamin E and antioxidants can decrease the build-up of harmful chemicals that
can cause injury to tissue. It is often used as the traditional treatment; it is inexpensive
and with proper dosing, there are minimal side effects. Other oral agents include Potaba
(aminobenzoates potassium); however, it is expensive ($1000 per year) and has associated
gastrointestinal side effects.
Other therapies involve injections directly in the plaques (intralesional) with chemicals
such as collagenase or calcium-channel blockers.
Surgical therapies are offered once the disease is stable (symptoms present for one year).
Invasive surgical options consist of correction of the penile curvature or the placement of
a penile prosthesis to straighten the penis to allow for erections.
Mesenchymal stem cells (MSCs) have been used for a variety of medical treatments to repair
and regenerate acute and chronically damaged tissues. These cells have the potential to
repair human tissue by forming cells of mesenchymal origin, such as cartilage, bone, fat,
muscle, and blood vessels. Most research has focused on bone marrow derived stem cells (BMC)
however the process for harvesting the cells is invasive, painful, and yields a low cell
count. The human placenta offers an alternative source form MSCs. Placental Matrix-Derived
Mesenchymal Stem Cells (PMD-MSCs) are compromised of a novel cellular repair matrix derived
from placental mesenchyme. Mesenchyme is the meshwork of embryonic connective tissue in the
mesoderm, from which are formed the muscular and connective tissues of the body and also the
blood vessels. PMD-MSCs provide the extracellular matrix viable mesenchymal stem cells
(MSCs) that coordinate the tissue repair process, regenerative growth factors, and
anti-inflammatory cytokines required to regenerate the damaged vasculature of the penile
The research proposed here will establish the safety and feasibility of utilizing
intracavernosal, intralesional injections of PMD-MSCs to treat Peyronie's disease with the
intent of avoiding surgery.
1. acquired penile curvature >15 and <90 degrees associated with palpable penile plaque
on physical examination
2. 1 or 2 penile plaque at screening
1. taking the medication Coumadin
2. unable to achieve adequate erection with penile injection to access degree of
3. undergone definitive treatment for prostate cancer, bladder cancer, or other pelvic
malignancies including surgery, external beam radiation therapy, brachytherapy,
4. prior history of prostate cancer, hematologic disorders, chronic liver disease
including cirrhosis and hepatitis C, disorders affecting the immune system, including
infection with the human immunodeficiency virus, or psychiatric disorder including
major depression, schizophrenia, bipolar disease
5. history of cerebrovascular accident, history of deep venous thrombosis within the
past 5 years or history of untreated or severe sleep apnea
6. clinically significant abnormal lab results that would put the subject at increased
risk or compromise the integrity of the study data, in the opinion of the
7. received any other investigational drug within 30 days