A Randomized Clinical Trial to Assess Safety and Efficacy of Allogeneic Adipose-derived Mesenchymal Stem Cells in Promoting the Recovery of Erectile Function Post Radical Retropubic Prostatectomy of Localized Prostate Cancer
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Change in erectile function by IIEF
研究概览
简要总结
This is a phase 1/2 single center, pilot study to assess safety and efficacy of allogeneic adipose-derived mesenchymal stem cells (HB-adMSCs) and to evaluate the timing and combination effects of active treatment versus placebo in promoting the recovery of erectile function in patients undergoing radical retropubic prostatectomy (RALP) of localized prostate cancer.
详细描述
This is a prospective, single-center, double blind, four-arm, pilot study to evaluate safety and effectiveness of allogeneic stem cells promoting the recovery of erectile function in patients undergoing radical retropubic prostatectomy (RALP) of localized prostate cancer.
All participants will be assessed for eligibility Participants will be randomized in a 1:1:1:1 ratio to Arm 1, Arm 2, Arm 3 or Arm 4 using a validated system that automates the random assignment of participant numbers to randomization numbers.
Study participants will be randomized to receive either:
Arm 1 2.00x 10⁸ HB-adMSCCs locally injected into the corpora cavernosa of the penis and along the right and left neurovascular bundle of the penis in the OR at week 1 plus Placebo via IV in clinic at week 12.
Arm 2 Placebo locally injected into the corpora cavernosa of the penis and along the right and left neurovascular bundle of the penis in the OR at week 1 plus 2.00x 10⁸ HB-adMSCs via IV in clinic at week 12.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •Patients scheduled for RALP with Dr. B. Miles at Houston Methodist.
- •Men aged between 40 and 70 (inclusive) years old
- •Localized prostate cancer: Clinical stage T1-T2, N0, M0
- •Gleason score < 7
- •Pre-op IIEF-5 >20 (Appendix A)
- •Testosterone serum: > 300ng/dl with normal Free Testosterone
- •Life expectancy of at least 10 years
- •Performance status of ≤ 2 (Zubrod scale). (Appendix B)
- •Patients must sign an informed consent indicating that they are aware of the investigational nature of the study, in keeping with the policies of the institution
- •Patient is willing to attempt intercourse at least 5 times per month following urinary control after surgery
- •Supportive partner willing to complete sexual survey questionnaire (Appendix D)
- •PDE5 inhibitors like sildenafil, tadalafil, vardenafil and avanafil are permitted pre and post-surgery if participant was taking this for ED at least 6 months before surgery.
- •Patient need cardiac clearance by the cardiologist
排除标准
- •Penile anatomical abnormalities (Peyronie's disease)
- •Hypogonadism
- •Any medication used for androgen ablation (e.g., LHRH agonist or antagonist, anti-androgens, etc.)
- •Patients with AST levels above 40U/L ; ALT levels above 33 U/L and Glucose levels above 180 mg/dl and psychiatric disorders that require medication
- •Previous or current hormonal treatment, chemotherapy, radiation therapy, immunotherapy or another investigational drug.
- •Any previous penile implant or penile vascular surgery
- •Injections of Trimix (combination of alprostadil, papaverine and phentolamine) pre and post-surgery .
研究组 & 干预措施
2: Placebo plus allogeneic adipose-derived mesnchymal stem cells
4 cc of saline solution in the corpora cavernosa of the penis and 4 cc of saline solution along the right and left neurovascular bundles of the penis in the OR at week 1 plus 2.00x 10⁸ HB-adMSCs via IV in clinic at week 12.
干预措施: Allogeneic adipose-derived mesenchymal stem cells (HB-adMSCs) at the doctor's office (Drug)
1: allogeneic adipose-derived mesnchymal stem cells plus saline solution
2.00x 10⁸ HB-adMSCCs locally injected into the corpora cavernosa of the penis and along the right and left neurovascular bundle of the penis in the OR at week 1 plus Placebo via IV in clinic at week 12.
干预措施: Allogeneic adipose-derived mesenchymal stem cells (HB-adMSCs) in the OR (Drug)
2: Placebo plus allogeneic adipose-derived mesnchymal stem cells
4 cc of saline solution in the corpora cavernosa of the penis and 4 cc of saline solution along the right and left neurovascular bundles of the penis in the OR at week 1 plus 2.00x 10⁸ HB-adMSCs via IV in clinic at week 12.
干预措施: Placebo in the OR (Drug)
3: allogeneic adipose-derived mesnchymal stem cells intra op and at week 12 in clinic
2.00x 10⁸ HB-adMSCs locally injected into the corpora cavernosa of the penis and along the right and left neurovascular bundle of the penis in the OR at week 1 plus 2.00x 10⁸ HB-adMSCs via IV in clinic at week 12.
干预措施: Allogeneic adipose-derived mesenchymal stem cells (HB-adMSCs) at the doctor's office (Drug)
3: allogeneic adipose-derived mesnchymal stem cells intra op and at week 12 in clinic
2.00x 10⁸ HB-adMSCs locally injected into the corpora cavernosa of the penis and along the right and left neurovascular bundle of the penis in the OR at week 1 plus 2.00x 10⁸ HB-adMSCs via IV in clinic at week 12.
干预措施: Allogeneic adipose-derived mesenchymal stem cells (HB-adMSCs) in the OR (Drug)
4: placebo plus placebo
4 cc of saline solution in the corpora cavernosa of the penis and 4 cc of saline solution along the right and left neurovascular bundles of the penis in the OR at week 1 plus saline solutin via IV in clinic at week 12.
干预措施: Placebo in the OR (Drug)
4: placebo plus placebo
4 cc of saline solution in the corpora cavernosa of the penis and 4 cc of saline solution along the right and left neurovascular bundles of the penis in the OR at week 1 plus saline solutin via IV in clinic at week 12.
干预措施: Placebo in clinic (Drug)
1: allogeneic adipose-derived mesnchymal stem cells plus saline solution
2.00x 10⁸ HB-adMSCCs locally injected into the corpora cavernosa of the penis and along the right and left neurovascular bundle of the penis in the OR at week 1 plus Placebo via IV in clinic at week 12.
干预措施: Placebo in clinic (Drug)
结局指标
主要结局
Change in erectile function by IIEF
时间窗: from baseline to 6 months post treatment
IIEF-5 is a tool to asses erectile dysfunction base on five questions about confidence, hardness, maintenance and satisfaction of erections. Score: 1 to 25.
Change in erectile function by Epic 26
时间窗: from baseline to 6 months post treatment
This questionnaire is designated to measure Quality of Life issues.Clinical relevance (\>12 points) for sexual function domain score as measured by EPIC-26.
Number of Participants With Severe Adverse Events (AEs), Serious Adverse Events (SAEs), Treatment-Related AEs, Deaths, Discontinuation of Study Drug Due to AEs, Immune-Related Adverse Events (irAE)
时间窗: 6 months
AE=any new unfavorable symptom, sign or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity or drug dependency/abuse; is life-threatening, an important medical event or a congenital anomaly/birth defect; or requires or prolongs hospitalization. Treatment-related=having certain, probable, possible or missing relationship to study drug. Death=during study and up to 70 days after last dose. IrAEs=AEs potentially associated with inflammation and considered to be causally related to study drug
Change in erectile function by Epic 26
时间窗: from baseline to 6 months post treatment
This questionnaire is designated to measure Quality of Life issues.Clinical relevance (\>12 points) for sexual function domain score as measured by EPIC-26.
次要结局
- Change in urinary function(from baseline to 6 months post treatment)
- Change in urinary function(from baseline to 6 months post treatment)
研究者
Brian Miles
MD
The Methodist Hospital Research Institute