As part of an investigator-initiated five patient pilot study in Japan, Cytori was informed that stem and regenerative cells from a patient’s own fat tissue were used to treat stress urinary incontinence (SUI). Reportedly, the results reported at the 7th annual meeting of the International Federation for Adipose Therapeutics and Science, suggest that the investigational treatment is safe and feasible. The cells in the study were processed using Cytori’s Celution 800 System during the operative procedure.
The company has said that as part of the procedure, adipose-derived stem and regenerative cells (ADRCs) were delivered via two distinct formulations. First, they were injected directly into the sphincter with the goal of improving muscle contraction. Secondly, ADRCs were combined with the patient’s own fat tissue to create a cell-enriched bulking agent with the goal to improve closure upon sphincter contraction.
In the study the patients underwent follow-up examinations at two, four, eight, and 12 weeks and were assessed on the basis of continence, intraurethral and leak point pressures, patient quality-of-life assessment, and a variety of imaging studies. SUI in all five study patients resulted from prior radical prostatectomy.
The results suggested at twelve weeks following treatment, three of five patients showed improvement in measures of leakage, urethral closure, and patient quality-of-life assessment. The three patients were diagnosed as having severe incontinence.
However two of the five patients did not show improvement in these measures and were diagnosed as having very severe incontinence before treatment. It is likely that these very extreme cases, which represent the most difficult clinical challenge, could require multiple treatments.
Tokunori Yamamoto, associate professor, department of urology of Nagoya University Graduate School of Medicine, said: “We confirmed that the transplanted cells stimulate new blood supply in the treated area, stabilize the transplanted tissue over time, and increase the urethral pressure in the majority of patients treated. These early findings give hope to millions of patients suffering from untreatable incontinence and the resulting impact on their quality of life. Based on these results, we look forward to expanding the study to a larger population of patients.”