Health TrialsbyHealthPanel

Stem Cells for Erectile Dysfunction Post RALP

ConditionsErectile DysfunctionProstate Cancer
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexMale
Age40-70
SponsorThe Methodist Hospital Research Institute

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Factorial

Treatments tested in this trial

  • Allogeneic adipose-derived mesenchymal stem cells (HB-adMSCs) at the doctor's office

    Drug

    2.00x10⁸ HB-adMSCs IV at the doctor's office.

  • Allogeneic adipose-derived mesenchymal stem cells (HB-adMSCs) in the OR

    Drug

    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

  • Placebo in the OR

    Drug

    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 .

  • Placebo in clinic

    Drug

    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.

Treatment groups

40 Participants
are divided into 4 treatment groups
Group A: 1: allogeneic adipose-derived mesnchymal stem cells plus saline solutionExperimental treatment 2 interventions
Group B: 2: Placebo plus allogeneic adipose-derived mesnchymal stem cellsExperimental treatment 2 interventions
Group C: 3: allogeneic adipose-derived mesnchymal stem cells intra op and at week 12 in clinicExperimental treatment 2 interventions
Group D: 4: placebo plus placeboPlacebo comparator 2 interventions

Trial outcomes

Primary outcomes

1

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
2

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
3

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

Secondary outcomes

1

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The Methodist Hospital Research Institute

Lead sponsor

Source ClinicalTrials.gov
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