A new clinical trial at the University of Miami Miller School of Medicine will examine the use of platelet-rich plasma (PRP) for treating erectile dysfunction—one of the first such controlled studies in the United States to start enrolling patients.

“Unlike current treatments, which focus on treating symptoms, PRP is a regenerative therapy,” said Ranjith Ramasamy, MD, associate professor of urology, director of male reproductive medicine and surgery, and a specialist in the treatment of disorders of male infertility and sexual dysfunction. “Therefore, injections of PRP from the individual’s body may offer a potential cure for the underlying disease in some patients.”

Dr. Ramasamy is the principal investigator for the UM-funded study, “Safety and Efficacy of Autologous Platelet-Rich Plasma for Erectile Dysfunction.” Enrollment will begin in June under the guidance of the Miller School’s Department of Urology.

“PRP been used in orthopedics, dermatology, and other fields for many years,” said Dr. Ramasamy. “While there have been many claims about using PRP for erectile dysfunction, to date there have been no rigorous clinical studies.”

The UM clinical trial is designed to test both the safety and effectiveness of PRP injections. It is a double blind, randomized study in which 40 of the 80 participants will receive PRP from their own blood, and 40 will receive a placebo, according to Thomas A. Masterson MD, a Miller School fellow in reproductive urology and co-investigator in the trial.

“When platelets are activated, they release growth factors that can facilitate regeneration of the blood vessels as well as penis tissue,” said Dr. Masterson. “If PRP proves to be effective, it could be a game changer in treating erectile dysfunction because men no longer need to rely on pills or injections every time.”

Participants with diabetes- or vascular-related erectile dysfunction will be recruited for the trial and followed for 6 months. However, individuals with underlying nerve or neurological conditions, such as a loss of sensation in the penis, would not be eligible.

To address COVID-19 safety concerns, the University of Miami is taking precautions for clinical trial participants, as well as patients, to receive care in a safe environment. Examination rooms are carefully disinfected, and doctors and nurses wear personal protective equipment such as goggles, gloves, and facemasks. Non-COVID patients are kept in areas separate from COVID-19 patients and anyone with a suspected case of coronavirus is treated in an isolated area.