Stem Cells for Erectile Dysfunction Post RALP

Официальное название

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

Обзор

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.

Подробное описание

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.

Arm 3 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.

Arm 4 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 Placebo via IV in clinic at week 12.

Study Medication:

1. Stem cells locally injected in the penis: subjects will receive 1.00x 10⁸ HB-adMSCs injection into the corpora cavernosa of the penis and 5.0x10⁷ HB-adMSCs along the right neurovascular bundle and 5.0x10⁷ HB-adMSCs along the left neurovascular bundle during surgery in the Operating Room (OR) 2. Stem cells delivered intravenous: Subject will receive 2.00x10⁸ HB-adMSCs IV at the doctor's office.

The treatment duration will be 2 cycles. Treatment will be administered on Week 1 (in the OR) and on week 12 in the Urology Clinic.

The study duration will be 24 weeks post-surgery.

Вмешательства

• Препарат Allogeneic adipose-derived mesenchymal stem cells (HB-adMSCs) at the doctor's office
  2.00x10⁸ HB-adMSCs IV at the doctor's office.
• Препарат Allogeneic adipose-derived mesenchymal stem cells (HB-adMSCs) in the OR
  100 million stem cells (1.00x10⁸ HB-adMSCs) in the corpora cavernosa of the penis suspended in a 4 cc of sterile saline. 50 million stem cells (5.0x 10⁷ HB-adMSCs) along the right neurovascular bundle and 50 million cell (5.0x 10⁷ HB-adMSCs) along the left neurovascular bundle of the penis suspended in a 4 cc of sterile saline during the surgery
• Препарат Placebo in the OR
  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 during the surgery .
• Препарат Placebo in clinic
  30 mL syringe of the product should be mixed into a 250cc bag of sodium chloride solution 0.9% for infusion. should be administered intravenously, with a dosing rate of 4-5mL/min.

Первичные конечные точки

• Change in erectile function by IIEF [Срок оценки: from baseline to 6 months post treatment]
• Change in erectile function by Epic 26 [Срок оценки: from baseline to 6 months post treatment]
• 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) [Срок оценки: 6 months]

Вторичные конечные точки (1)

• Change in urinary function [Срок оценки: from baseline to 6 months post treatment]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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 .

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Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Факторный дизайн

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Houston Methodist — Houston

Идентификаторы

NCT: NCT07048314 · Pro00039638

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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