Treatment With Stromal Vascular Fraction of Peyronie´s Disease in Humans
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Change in the bend of the erect penis
研究概览
简要总结
Purpose of the project is to investigate if a single injection of autologous stromal vascular fraction into and around plaque is a safe and suitable treatment.
Twentythree men > 18 years with Peyronie´s Disease in the chronic phase will be recruited.
The operative same-day procedure will be performed in general anaesthesia by a plastic surgeon. Before the patient wake, local anaesthesia is put around the penis. Processed stem cells are injected into the plaque/fibrosis subcutaneously.
There will be a follow up at 1, 3, 6, 12 months. It is a pilot study with no randomisation. The group will be compared to a historical control group.
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 80 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Acquired penile curvature >30 and <90 degrees associated with a palpable penile plaque on physical examination.
- •One or several plaques at ultrasound screening.
- •Willingness to attend follow-up at 1, 3, 6 and 12 months.
- •Understand and speak Danish.
- •Men > 18 years of age
排除标准
- •Patients may not be:
- •Taking the medication Coumadin, Warfarin or NOAK (new oral anticoagulant).
- •Unable to achieve adequate erection with penile injection to access degree of curvature.
- •Undergoing definitive treatment for prostate cancer, bladder cancer, or other pelvic malignancies including surgery, external beam radiation therapy, brachytherapy, and cryotherapy.
- •With 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 disorders including but not limited to major depression, schizophrenia, bipolar disease.
- •With a history of cerebrovascular incidents, a history of deep venous thrombosis within the past 5 years or a history of untreated or severe sleep apnoea.
- •With a clinically significant abnormal, results that would put the subject at increased risk or compromise the integrity of the study data, in the opinion of the investigator. Blood tests will be analysed for HIV, Hepatitis B and C and syphilis and those applicable within guidelines of the department.
- •Involved with any other projects with an investigational drug within 30 days.
- •In treatment for alcohol or drug abuse within six months.
- •With congenital deviation of penis.
- •Within six months treated with Collagenase, ESWT and/or other therapeutic injection in the plaque treatment for PD.
研究组 & 干预措施
Stromal vascular fraction injection
Intervention:
Single injection with autologous adipose tissue-derived stromal vascular fraction cells in and around the plaque.
干预措施: Stromal vascular fraction (Drug)
结局指标
主要结局
Change in the bend of the erect penis
时间窗: [measured at baseline, 1, 3, 6, 12 months]
Changes in degrees measured with a goniometer compared to baseline
次要结局
- Change in Peyronie´s disease questionnaire bother symptoms([measured at baseline, 1, 3, 6, 12 months])
- Change in stretched Penile Length from symphysis to meatus of the glans (cm)([measured at baseline, 1, and 12 months])
- Change in International Index of Erectile Function score,([measured at baseline, 1, 3, 6, 12 months].)
- Change in penile Plaque size (mm3)([measured at baseline, 1, and 12 months])