Treatment with Autologous Adipose-derived Regenerative Cells for Peyronie's Disease in Men: The Straight @head Pilot Study.

BACKGROUND AND

OBJECTIVE

We evaluated the effectiveness of injecting autologous adipose-derived regenerative cells (ADRCs) into plaque in men with chronic Peyronie's disease (PD).

METHODS

This pilot safety study recruited 22 Danish men with chronic PD from an outpatient clinic. Patients received one bolus of ADRCs injected into plaque, with follow-ups at 1, 3, 6, and 12 mo. The primary endpoint was a reduction in penile curvature. Secondary endpoints were serious adverse events in relation to treatment, and patient-reported results for improvements, distress, and unhappiness related to PD.

KEY FINDINGS AND LIMITATIONS: There was no significant difference in curvature after treatment. However, the participants reported subjective improvements, less distress, and a decrease in unhappiness. No severe adverse events were observed during 12-mo follow-up.

CONCLUSIONS AND CLINICAL IMPLICATIONS: Injections of ADRCs into PD plaque appear to be safe but had no significant measurable effect on penile curvature. Half of the participants reported a subjective improvement.

PATIENT SUMMARY: We studied the safety and effectiveness of injections of patient-derived regenerative cells for chronic Peyronie's disease. While the curvature of the penis did not significantly improve, the treatment was safe and some men reported a decrease in their distress and an improvement in penile shape.