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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
40
2.00x10⁸ HB-adMSCs IV at the doctor's office.
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
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 .
Houston Methodist
Houston, Texas, United States
Change in erectile function by IIEF
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.
Time frame: from baseline to 6 months post treatment
Change in erectile function by Epic 26
This questionnaire is designated to measure Quality of Life issues.Clinical relevance (\>12 points) for sexual function domain score as measured by EPIC-26.
Time frame: 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)
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
Time frame: 6 months
Change in urinary function
This questionnaire is designated to measure Quality of Life issues.Clinically relevant (≥9 points) difference in the EPIC-26 urinary incontinence domain score
Time frame: from baseline to 6 months post treatment
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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.