Evaluate the Safety and Feasibility of Injecting Placental Matrix-Derived Mesenchymal Stem Cells Into the Penis to Treat the Symptoms of Peyronie's Disease
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Peak Systolic Velocity without trimix (cm/s)
研究概览
简要总结
Prospective, open labeled, non-randomized, study to be conducted at a single center. Ten subjects will undergo an injection of Placental Matrix-Derived Mesenchymal Stem Cells (PMD-MSCs) into the penis for the treatment of Peyronie's Disease. Follow up visits will be conducted at 6 weeks, 3 months, 6 months, and 12 months. Subjects will be eligible for re-injection at 3 months and/or 6 months as determined by the clinician based on patient reported treatment satisfaction.
详细描述
Symptoms of Peyronie's disease include penile pain and curvature of the penis that prevents penetration and/or causes erectile dysfunction (ED). It is characterized by plaques that form along the top or bottom side of the penis inside the tunica albuginea; the plaque begins as a localized inflammation then develops into a hardened scar. Cases can range from mild to severe. In several cases, the hardened plaque reduces flexibility, causing the penis to curve during erection. The sexual problems as a result can lower a man's self-esteem and interfere with a couple's physical and emotional relationship.
The cause is unknown; however, possibilities include trauma, inherited conditions, Vitamin E deficiency, diabetes, and vascular disease.
Conservative treatments used in the acute phase (initial onset of symptoms) include oral therapies. Vitamin E and antioxidants can decrease the build-up of harmful chemicals that can cause injury to tissue. It is often used as the traditional treatment; it is inexpensive and with proper dosing, there are minimal side effects. Other oral agents include Potaba (aminobenzoates potassium); however, it is expensive ($1000 per year) and has associated gastrointestinal side effects.
Other therapies involve injections directly in the plaques (intralesional) with chemicals such as collagenase or calcium-channel blockers.
Surgical therapies are offered once the disease is stable (symptoms present for one year). Invasive surgical options consist of correction of the penile curvature or the placement of a penile prosthesis to straighten the penis to allow for erections.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •acquired penile curvature >15 and <90 degrees associated with palpable penile plaque on physical examination
- •1 or 2 penile plaque at screening
排除标准
- •taking the medication Coumadin
- •unable to achieve adequate erection with penile injection to access degree of curvature
- •undergone definitive treatment for prostate cancer, bladder cancer, or other pelvic malignancies including surgery, external beam radiation therapy, brachytherapy, cryotherapy
- •prior history of prostate cancer, hematologic disorders, chronic liver disease including cirrhosis and hepatitis C, disorders affecting the immune system, including infection with the human immunodeficiency virus, or psychiatric disorder including major depression, schizophrenia, bipolar disease
- •history of cerebrovascular accident, history of deep venous thrombosis within the past 5 years or history of untreated or severe sleep apnea
- •clinically significant abnormal lab results that would put the subject at increased risk or compromise the integrity of the study data, in the opinion of the investigator
- •received any other investigational drug within 30 days
研究组 & 干预措施
Injection of PMD-MSCs into the penis
Subjects will receive an initial injection of 1.0cc of Placental Matrix-Derived Mesenchymal Stem Cells (PMD-MSCs). Subjects will be eligible for re-injection at 3 months and/or 6 months as determined by the clinician based on ultrasound guided measurements of penile plaque(s) post treatment and on patient reported treatment satisfaction.
干预措施: Placental Matrix-Derived Mesenchymal Stem Cells (PMD-MSCs) (Biological)
结局指标
主要结局
Peak Systolic Velocity without trimix (cm/s)
时间窗: 12 months
Peak Systolic Velocity without trimix (cm/s)
时间窗: Baseline
Peak Systolic Velocity without trimix (cm/s)
时间窗: 6 weeks
Peak Systolic Velocity without trimix (cm/s)
时间窗: 3 months
Peak Systolic Velocity without trimix (cm/s)
时间窗: 6 months
次要结局
- End Diastolic Velocity without trimix (cm/s)(12 months)
- End Diastolic Velocity without trimix (cm/s)(3 months)
- End Diastolic Velocity without trimix (cm/s)(Baseline)
- End Diastolic Velocity without trimix (cm/s)(6 weeks)
- End Diastolic Velocity without trimix (cm/s)(6 months)
研究者
Melissa Marchand
PA-C
Z Urology