星期五，7月09,201
Patient’s cells may control urine leakage
泌尿科医生Beaumont Hospital, Royal Oak正在研究使用女性自己的肌肉细胞的应激尿失禁的研究的安全性和潜在效果。
Many women experience leakage of urine, a condition called stress urinary incontinence, or SUI. When there is a sudden increased pressure on the bladder, such as when laughing, coughing, sneezing, or exercising, urine can leak. The leaks are a result of weakened muscles that control urine flow. SUI is very common in women of all ages.
Beaumont researchers are currently enrolling women ages 50 - 75 in the study, known as the CELLEBRATE study, who meet specific criteria, including those who:
- Experience urine leakage on effort or exertion, or on sneezing or coughing, at least three time a day.
- Have tried pelvic floor muscle training that did not help with their symptoms.
If participants meet the CELLEBRATE study criteria and choose to take part, the study could last for up to 2.5 years and requires eight to 11 visits to the study center. Participants are randomly assigned to a study group to receive either the investigational product or the placebo. The placebo looks like the investigational product but will not contain muscle cells or any other active substance. Participants have an equal chance of receiving the investigational product or placebo. If a participant is assigned to the placebo group, they would have an opportunity to receive the investigational product after their first year in the study. All participants will be reimbursed for travel to the study site.
Researchers will collect a small sample of muscle tissue from the leg of each participant. The muscle tissue collected is sent to a laboratory for processing. The returned cells will then be injected into the sphincter, a muscle which controls urination.
主要调查员，Dr. Larry Sirls, urologist and director, Female Pelvic Medicine and Reconstructive Surgery at Beaumont, Royal Oak, said, “It’s an approach using a woman’s own leg muscle cells in an effort to control the leakage of urine. This could improve quality of life and self-esteem issues.”
Stress urinary incontinence affects about 15 million adult women nationwide. Current treatments, including medicine, exercise, and surgery, are not always effective and may have undesirable side effects.
Sirls博士，“我们希望注射细胞增强肌肉 - 让括约肌保留尿液。如果成功，肌肉衍生的细胞疗法可以为寻求无泌尿泄漏的人们提供另一种治疗选择。“
要了解更多about participant eligibility and study criteria, contactBeaumont Urology Research at 248-551-3355 orerica.zagaja@beaumont.org.
包括Beaumont Royal Oak，Cellebrate学习是在全国范围内的22个地点进行，由Cook Myositial Inc.赞助，一部分的厨师组。ClinicalTrials.gov标识符：nct03104517..
Beaumont神经学博士博士迈克尔大学博士是该肌肉衍生的细胞过程中的发明人之一。虽然没有参与这项特定的研究，但总理博士博士收到肌肉衍生的细胞流程和付款的特许权使用费和咨询烹饪Myosity Inc.