Platelet Rich Plasma - Derived Exosomes Therapy for Erectile Dysfunction: A Feasibility Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- The % of patients in each group who attain Minimal Clinically Important Difference (MCID) in the International Index for Erectile Function- Erectile Function (IIEF-EF) domain
研究概览
简要总结
It will be a Single-arm, single-center, feasibility clinical trial with Primary Objective to investigate the treatment efficacy of PRP-derived exosomes injection in men with mild-moderate vasculogenic ED, as measured by the International Index of Erectile Function (IIEF). Also secondary objectives will be to study the adverse events and safety of the PRP-derived exosomes injection treatment in vasculogenic ED patients Study Centers The study will be carried out at Saint Lucas Hospital, Thessaloniki, Greece. Laboratory tests of all patients will be performed at the hospital's microbiology laboratory. PRP-derived exosomes preparation and application will take place at the Regenerative Clinic.
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
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Consent to participate.
- •Age 40-70 years.
- •Sexually active in a stable, heterosexual relationship of more than three months duration.
- •Presence of ED for at least 6 months.
- •IIEF-ED: 17-25 at visit
- •The IIEF classifies the severity of ED into five categories stratified by score: No ED: 26-30, Mild ED: 22-25, Mild to moderate ED: 17-21, Moderate ED: 11-16 and Severe ED: 6-
- •Patients will be PDE5i users for at least 6 months and report some/good response to PDE5i in the last month before screening (at visit 1
- •Agree to suspend all ED therapy for the duration of the study.
- •Agree to attempt sexual intercourse at least 4 times every 3 weeks for the duration of the study without being under the influence of alcohol or recreational drugs.
- •Agree to document the outcome using IIEF questionnaire during every visit and the Sexual Encounter Profile (SEP) diary, as needed (months 1 and 3 post treatment).
排除标准
- •Previous major pelvic surgery or pelvic trauma that could impact EF, such as radical prostatectomy, radical cystectomy, or rectal surgery. 19
- •Patients with previous transurethral resection of the prostate (TURP) surgery without sequelae of iatrogenic ED may be included.
- •Previous penile surgery of any kind except circumcision and condyloma removal, such as penile lengthening, penile cancer surgery, penile plication, and grafting.
- •Previous history of priapism or penile fracture
- •Previous radiation therapy to the pelvis.
- •Abnormal morning serum testosterone level, defined as a value lower than 300 ng/dL (indicative of untreated hypogonadism) or greater than1197 ng/dL.
- •Current or previous hormone use, other than prescribed testosterone, clomiphene or thyroid medication. Subjects with prior or current use of hormonal treatment for prostate cancer are also excluded.
- •Psychogenic ED.
- •Peyronie's Disease or penile curvature that negatively influences sexual activity.
- •Anatomical or neurological abnormalities in the treatment area.
- •Any untreated medical condition (based on medical history)
- •Patients with generalized polyneuropathy or neurological conditions irrespective of cause, such as severe diabetes, multiple sclerosis, or Parkinson's Disease.
- •Refusal to suspend ED therapy for the duration of the study. Subjects who are using Tadalafil as a treatment for benign prostatic hyperplasia (BPH) will also be excluded.
- •Men deemed not healthy enough to participate in sexual activity.
- •Any condition or behavior that indicates to the Principal Investigator that the subject is unlikely to be compliant with study procedures and visits.
- •Any health history or laboratory result that indicates to the Principal Investigator that the subject has a significant medical condition and should not participate in the study.
- •History of consistent treatment failure with PDE5 inhibitors for therapy of ED.
- •Any history of significant psychiatric diseases, such as bipolar disorder or psychosis, greater than one lifetime episode of major depression, current depression of moderate or greater severity.
- •Patients who are currently using SSRI or psychotropic medications.
- •Partners who are < 18 years of age, who are nursing, who wish to become pregnant during the study period, and who have any gynecologic problems, sexual dysfunction, or major medical conditions that would limit participation in sexual intercourse.
- •Patients with any hematological disorder
研究组 & 干预措施
Study Arm
All patients will be regular PDE5I users/responders. After one one-month washout period, ED patients will be screened by the IIEF-EF domain, and 30 eligible patients will be enrolled. subjects will receive three sessions of PRP-derived exosomes injection with 21± 3 days treatment interval.
干预措施: PRP-derived exosomes injection (Biological)
结局指标
主要结局
The % of patients in each group who attain Minimal Clinically Important Difference (MCID) in the International Index for Erectile Function- Erectile Function (IIEF-EF) domain
时间窗: From baseline to 12 weeks after final treatment
The IIEF classifies the severity of ED into five categories stratified by score: No ED: 26-30, Mild ED: 22-25, Mild to moderate ED: 17-21, Moderate ED: 11-16 and Severe ED: 6-10. MCID values for the IIEF-EF (Erectile Function) domain are 2-point increase for mild ED, a 5-point increase for moderate ED and a 7-point increase for severe ED In IIEF-EF score higher values mean better outcome
次要结局
- The % of patients who attain Minimal Clinically Important Difference(MCID) in the International Index for Erectile Function- Erectile Function (IIEF-EF) domain .(From baseline to 4 weeks after final treatment)
- The change of the International Index for Erectile Function- Erectile Function (IIEF-EF) domain from baseline to 12 weeks after final treatment.(From baseline to 12 weeks after final treatment.)
- Adverse events in all patients(Periprocedural)