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 L. Berman MD*, Jackie R. See M.D.
California Stem Cell Treatment Center and Cell Surgical Network
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 Treatment of Peyronies Disease in four patients. Autologous SVF can be easily obtained from adipose tissue lipo-aspirate 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.
METHODS: Four 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 6 months.
OBJECTIVES: Clinically significant improvement over baseline was seen in all 4 patients at six months. There were no adverse events. All patients noted subjective straightening of the penis some with complete response and all patients reported subjective reduction in plaque size. EHGS mean scores increased from 1.75 to 3.5 at six months. All four patients described subjective improvement in curvature and erectile function. Peyronies Disease Questionnaire scores at three decreased from mean 22.3 to 8.3.