Bone Marrow Mononuclear Cells or Human Umbilical Cord-derived Mesenchymal Stem Cells Combined With NeuroRegen Scaffold™ Transplantation for the Improvement of Erectile Function in Men After Rectal Cancer Surgery
试验速览
- 阶段
- 1 期
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Safety and Tolerability assessed by Adverse Events
研究概览
简要总结
Erectile dysfunction (ED) is one of the commonest complications in men after rectal cancer treatment. The purpose of this study is to assess the safety and efficacy of autologous bone marrow mononuclear cells (BMMCs) or allogeneic human umbilical cord-derived mesenchymal stem cells (HUC-MSCs) combined with NeuroRegen scaffold transplantation in men with erectile dysfunction after rectal cancer treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with local rectal cancer, which is within 12cm from anus.
- •Male, 20-65 years old.
- •IIEF-5 score>
- •No obvious abnormal in external genitalia, testis, epididymis and spermatic cord.
- •Have a consistent partner who is willing to engage in sexual activity more than twice per month during the study.
- •Signed informed consent.
- •Recently take no drugs affecting sexual function (such as androgen replacement drugs, PDE5i and Chinese patent medicine, etc.).
排除标准
- •Suffering hypertension or diabetes.
- •In the investigators judgment, with clinical significance of penis abnormalities, or has received penile prosthesis implantation surgery.
- •Patient's partner is trying to conceive during the trial period.
- •Exposure to any investigational drug or procedure within 1 month prior to study entry or enrolled in a concurrent study that may confound results of this study.
- •Geographically inaccessible for follow-up visits required by protocol or want to other treatment.
研究组 & 干预措施
Laparoscopic surgery
Patients receive no interventions after rectal cancer treatment.
干预措施: Laparoscopic surgery (Procedure)
NeuroRegen scaffold transplantation
Patients receive NeuroRegen scaffold transplantation after rectal cancer treatment.
干预措施: NeuroRegen scaffold transplantation (Device)
NeuroRegen scaffold/BMMCs transplantation
Patients receive autologous bone marrow mononuclear cells with NeuroRegen scaffold transplantation after rectal cancer treatment.
干预措施: NeuroRegen scaffold/BMMCs transplantation (Biological)
NeuroRegen scaffold/HUC-MSCs transplantation
Patients receive allogeneic human umbilical cord mesenchymal stem cells with NeuroRegen scaffold transplantation after rectal cancer treatment.
干预措施: NeuroRegen scaffold/HUC-MSCs transplantation (Biological)
结局指标
主要结局
Safety and Tolerability assessed by Adverse Events
时间窗: Up to 6 months
次要结局
- Nocturnal penile tumescence (NPT)(1, 3, 6, 12 months)
- Maximum Flow Rate (Qmax)(1, 3, 6, 12 months)
- IIEF-5 (International Index of Erectile Function)(1, 3, 6, 12 months)
- Penile cavernosal artery peak systolic velocity (PSV)(1, 3, 6, 12 months)
- Mean scores of the Sexual Encounter Profile (SEP) Question 2, 3(1, 3, 6, 12 months)
- The change of results of Nerve electrophysiological examination(1, 3, 6, 12 months)
研究者
Jianwu Dai
Principal Investigator of Regenerative Medicine Laboratory, Institute of Genetics and Developmental Biology, CAS
Chinese Academy of Sciences