Prospective Observational Study on Intracavernosal Injection of Autologous Adipose Tissue-Derived Stem Cells (ADSC) or Stem Cell-derived Exosomes for the Treatment of Erectile Dysfunction
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
- Change in Erectile Function as Measured by the International Index of Erectile Function (IIEF) Score
研究概览
简要总结
The goal of this prospective observational study is to evaluate whether injections of stem cells derived from the patient's own fat tissue (adipose tissue) can improve erectile function in men aged 30 to 75 who have erectile dysfunction (ED) and have not responded well to standard treatments like PDE-5 inhibitors (e.g., Viagra).
The main questions the study aims to answer are:
Will the stem cell injections improve erectile function, as measured by the International Index of Erectile Function (IIEF) score? Are there any changes in blood flow to the penis, which will be measured using a Doppler ultrasound?
Participants will:
Receive injections of their own stem cells (obtained from a biopsy of fat) directly into the penis.
Undergo assessments to check erectile function before and after treatment. Have follow-up visits at 3, 6, 9, and 12 months to monitor long-term effects. The study will also look for any possible side effects or complications and evaluate biological markers in the penis that may indicate the effectiveness of the treatment.
Participants will be recruited from clinic where they are already receiving care for ED. To take part, they must be in good overall health, with no severe heart disease, uncontrolled diabetes, cancer, or other conditions that could make stem cell therapy unsafe for them.
详细描述
Detailed Description:
This prospective observational study is designed to evaluate the safety and preliminary efficacy of intracavernosal injections of autologous adipose tissue-derived stem cells (ADSCs) or stem cell-derived exosomes for treating erectile dysfunction (ED) in men unresponsive to conventional therapies, such as phosphodiesterase type 5 (PDE-5) inhibitors. The primary focus will be on improvements in erectile function, as measured by changes in the International Index of Erectile Function (IIEF) score. Additionally, the study will assess penile hemodynamics, monitor adverse events, and explore biomarkers that may predict therapeutic outcomes.
Background and Rationale:
Erectile dysfunction affects a significant proportion of the male population, particularly with advancing age, and can result from various causes, including vascular, neurogenic, and psychogenic factors. Current standard treatments, such as PDE-5 inhibitors, are effective for many, but a substantial subset of patients-especially those with underlying vascular or nerve-related pathologies-experience inadequate therapeutic responses.
Regenerative medicine has emerged as a promising approach for addressing ED through tissue repair and vascular regeneration. Both ADSCs and stem cell-derived exosomes are potential therapies due to their ability to promote angiogenesis, tissue regeneration, and anti-inflammatory effects. ADSCs can be harvested from the patient's adipose tissue, minimizing the risk of immunogenicity or rejection. Exosomes derived from stem cells, on the other hand, offer a cell-free approach, delivering growth factors and signaling molecules to the target tissues. Preclinical studies have demonstrated the potential of these therapies to restore erectile function through tissue remodeling and enhanced penile blood flow following intracavernosal injection.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 30 Years 至 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Age: Adult males aged 30 to 75 years.
- •Diagnosis: Confirmed diagnosis of erectile dysfunction (ED) of mild to moderate severity, as defined by an International Index of Erectile Function (IIEF) score.
- •Treatment Response: Failure or suboptimal response to conventional ED treatments, such as PDE-5 inhibitors.
- •General Health: Overall good health without contraindications to stem cell therapy.
- •Informed Consent: Ability and willingness to provide written informed consent to participate in the study.
排除标准
- •Severe Cardiovascular Disease: Presence of severe cardiovascular conditions, including uncontrolled hypertension or significant heart disease.
- •Active Infections: Ongoing infections that could interfere with treatment or pose a risk to the participant.
- •Malignancies: History of or current cancer, including malignancies that could affect safety or treatment outcomes.
- •Contraindications to Stem Cell Therapy: Any medical conditions or treatments that contraindicate the use of stem cell therapy.
- •Uncontrolled Diabetes: Poorly controlled diabetes or other metabolic disorders that could impact treatment efficacy or safety.
- •Psychiatric or Cognitive Impairments: Significant psychiatric or cognitive disorders that may affect the participant's ability to comply with study protocols or provide informed consent.
- •Recent Surgery or Trauma: Recent major surgeries or physical trauma that could impact the study or interfere with the intervention.
- •Participation in Other Studies: Participation in other clinical trials or studies that may affect the outcomes or safety of this study.
结局指标
主要结局
Change in Erectile Function as Measured by the International Index of Erectile Function (IIEF) Score
时间窗: 12 months
The primary outcome measure for this study is the change in erectile function as assessed by the International Index of Erectile Function (IIEF) score. The IIEF is a validated questionnaire designed to evaluate various aspects of sexual health, including erectile function, sexual satisfaction, and overall sexual performance. Participants will complete the IIEF questionnaire at baseline and at follow-up visits to track changes in erectile function over time. The goal is to determine whether the intracavernosal injection of autologous adipose tissue-derived stem cells leads to significant improvements in erectile function compared to pre-treatment levels. The IIEF score will provide a comprehensive measure of treatment effectiveness and help assess the impact of the intervention on participants\' sexual health and quality of life.
次要结局
- Penile Hemodynamics as Measured by Doppler Ultrasound(12 months)
研究者
Ranjith Ramasamy
Consultant Urologist
Jumeirah American Clinic