Within three months, 83% of patients had a greater than 50% improvement in quality of life scores
ANAHEIM, Calif.—Endoscopic injections of human umbilical cord blood stem cells may be a safe treatment option for women with stress urinary incontinence (SUI), according to findings presented here at the American Urological Association annual meeting.
Human umbilical cord blood has received increased attention in recent years as a viable source for pluripotent stem cells that can have an array of applications. In this study, researchers from institutions in Los Angeles and Seoul, Korea explored whether cord blood stem cells could be used effectively in treating SUI in women.
“This is the first clinical trial that has been reported with this type of cord blood cells for urinary incontinence and it shows the importance of international collaborations,” said study investigator Chester Koh, MD, assistant professor in the division of pediatric urology at Children’s Hospital Los Angeles.
The study’s principal investigators were Chung No Lee, MD, and Jin Young Baek, MD. The trial was conducted at the CHA Gangnam General Hospital and Pochon CHA University College of Medicine in Seoul.
Human stem cells were isolated and processed from cord blood samples. A total of 39 women (mean age 51 years; range 40-61 years) with SUI underwent periurethral injection of the stem cells under local anesthesia. All patients were evaluated with standardized Incontinence Impact Questionnaire (IIQ), and Incontinence Quality of Life (I-QOL) questionnaires pre- and post-treatment. Five of the patients also underwent pre- and post-procedure urodynamics to analyze the maximal urethral closure pressures (MUCP).
The patients were followed for an average of 13 months (range 11-20 months). Minor postoperative complications included leakage of the injected cells in approximately 19% of patients. The procedure had to be terminated in two patients because of pain. The researchers observed no evidence of UTIs, urinary retention, voiding difficulty, or graft-versus-host disease.
Overall, 83% of patients experienced a greater than 50% improvement in quality of life within three months as measured by IIQ and I-QOL questionnaires. In the five patients who completed pre- and post-procedure urodynamics, MUCP was improved by a minimum of 30 cm H20. The investigators emphasized the simplicity of their treatment, noting that biopsies and cell cultures are not required.
Noting that trials of this experimental treatment are ongoing in Korea, Dr. Koh told Renal & Urology News, “The acceptance of stem cell therapy in Korea is much higher I think than it is in the United States. They have many fewer clinical and ethical issues, not that their ethical standards are less. They are just different.”
Dr. Koh said he thinks this approach eventually will be widely accepted in the United States. No treatments are currently available to improve urethral function in SUI sufferers.
Better than collagen
In a related development, a recently published Austrian study demonstrated that injections of autologous stem cells are superior to collagen injections for treating SUI. The trial, led by Hannes Strasser, MD, of the University of Innsbruck, enrolled 63 women with severe SUI.
The study, which was conducted between 2002 and 2004, compared injections of autologous skeletal muscle cells with endoscopic injections of collagen. Dr. Strasser and his colleagues harvested stem cells from skeletal muscle biopsies and used a specially designed device for the injections. Guided by ultrasonography, the stem cells were injected transurethally into the rhabdosphincter and urethra.
The researchers assessed continence on the basis of a 24-hour voiding diary, 24-hour pad test, and a patient questionnaire. Thirty-eight of 42 women (90%) in the stem-cell group achieved total continence within a year compared with only two of 21 women (9.5%) who received collagen.
In addition, stem cells had a dramatic impact on the thickness and contractibility of the rhabdosphincter. Starting from a baseline of 2.13 mm for all patients, mean thickness increased by 59% to 3.38 mm for the stem-cell group and rose only 9% to 2.32 mm in the collagen arm. Contractibility jumped by 268% (from 0.58 mm at baseline to 1.56 mm) in patients given the stem-cell injections compared with 15% (from 0.58 mm to 0.67 mm) in the collagen arm, Dr. Strasser’s group reported.
“After a median follow-up of three years, no severe adverse effects or scars have been reported, and postoperative results have not changed,” the investigators wrote in the Lancet (2007;369:2179-2186).
In an accompanying commentary, Giacomo Novara, MD, and Walter Artibani, MD, of the urology clinic at the University of Padua, Italy, declared that the trial “can be seen as the beginning of a new era in urogynecology. If the data are confirmed, this approach is likely to cause a substantial change in the treatment of female stress urinary incontinence and could become one of the most important innovations in urology since the development of extracorporeal shockwave lithotripsy for urinary stone treatment and tension-free vaginal tape for stress urinary incontinence.”