Stem Cells for Erectile Dysfunction Post RALP
Trial statusNot yet recruiting
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
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
Treatments tested in this trial
- Allogeneic adipose-derived mesenchymal stem cells (HB-adMSCs) at the doctor's office
- Allogeneic adipose-derived mesenchymal stem cells (HB-adMSCs) in the OR
- Placebo in the OR
- Placebo in clinic
Treatment groups
40 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov