Peyronie's Disease

The purpose of this clinical trial is to evaluate the effects of Platelet-Rich Plasma (PRP) intralesional injections in men affected by Peyronie's disease (PD) in the fibrotic phase.

Peyronie's Disease (PD) is a fibrosing disorder of the penis where scar tissue (composed of excessive and disorganized collagen) known as a "plaque," forms along the shaft of the penis. This plaque can lead to permanent penile deformity (curvature, narrowing, indentation, hinging), loss of penile length, erectile dysfunction, and pain during intercourse. Research has shown PD to negatively impact the quality of life and cause significant psychosocial distress for many men. At present, available medical and surgical treatment modalities for PD have limitations. Intralesional collagenase clostridium histolyticum (CCh) is approved for the reduction of penile curvature in PD, however, its use is restricted to the United States market. Other medical therapies including intralesional verapamil and interferon injections have inconsistent and modest effects while, invasive surgical management with plication or grafting can result in erectile dysfunction, penile length shortening, penile sensory changes, and harvest site complications. Fractional CO2 Laser Therapy is an extra-dermal (applied to the surface of the skin) and non-invasive treatment that involves the use of lasers to destroy and reduce abnormal collagen in scarred tissue. Most recently, it has been used in a pilot clinical trial investigating its use in the management of PD. All men in this study safely experienced reduction in their penile curvature. This will be a phase 1 clinical trial evaluating the safety and feasibility of using a fractional CO2 laser in the management of chronic phase PD. Enrolled study participants will undergo an initial clinical assessment of their PD which involves penile measurements at flaccid and erect states, a curvature assessment with duplex ultrasound, and will be asked to complete the International Index of Erectile Function Questionnaire (IIEF-5), and Peyronie's Disease Questionnaire (PDQ). They will then undergo 3 laser therapy sessions at 6 week intervals and will have a short and long-term follow-up of 24 and 52 weeks, respectively.

This trial will study the safety and efficacy of intravenous and intracavernosal or interstitial delivery of cultured allogeneic adult umbilical cord derived mesenchymal stem cells for the treatment of Peyronie's disease, erectile dysfunction , and Interstitial Cystitis