RightFit
RecruitingPhase 1 / Phase 2

Stem Cells for Erectile Dysfunction Post RALP

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
40 Years to 70 Years
Sex
Male only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Injections

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This early study tests whether stem cells from a donor’s fat are safe and help men regain erections after surgery to remove the prostate for cancer. It is for men ages 40–70 whose cancer has not spread beyond the prostate. The study compares stem cell treatment with a placebo (an inactive treatment) and tests treatment timing and combinations.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Men ages 40–70 scheduled for prostate removal surgery with Dr. B. Miles at Houston Methodist.
  • Prostate cancer that has not spread (stage T1–T2, N0, M0), with a Gleason score below 7, a measure of how the cancer cells look.
  • An erection survey score (IIEF-5) above 20 before surgery.
  • Total testosterone, a male sex hormone, above 300 ng/dL and a normal free testosterone level.
  • Expected to live at least 10 years, with a Zubrod activity score of 2 or less, meaning able to care for yourself and be up most of the day.
  • Must sign a consent form and get approval from a heart doctor.
  • Willing to try intercourse at least 5 times a month after bladder control returns, with a supportive partner willing to fill out a sex survey.
  • Erection pills such as sildenafil or tadalafil are allowed before and after surgery if used for erection problems for at least 6 months before surgery.

Who can't join

  • Problems with the shape of the penis, such as Peyronie’s disease, which causes a bend.
  • Low testosterone caused by a condition called hypogonadism.
  • Use of medicines that lower or block male sex hormones.
  • Liver blood test levels above the listed limits: AST above 40 U/L or ALT above 33 U/L; blood sugar above 180 mg/dL; or mental health conditions that need medicine.
  • Past or current hormone treatment, chemotherapy, radiation, treatment that uses the immune system, or another study drug.
  • A past penile implant or surgery on blood vessels in the penis.
  • Use of Trimix injections, a three-drug treatment for erection problems, before or after surgery.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: 1. Patients scheduled for RALP with Dr. B. Miles at Houston Methodist. 2. Men aged between 40 and 70 (inclusive) years old 3. Localized prostate cancer: Clinical stage T1-T2, N0, M0 4. Gleason score \< 7 5. Pre-op IIEF-5 \>20 (Appendix A) 6. Testosterone serum: \> 300ng/dl with normal Free Testosterone 7. Life expectancy of at least 10 years 8. Performance status of ≤ 2 (Zubrod scale). (Appendix B) 9. 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 10. Patient is willing to attempt intercourse at least 5 times per month following urinary control after surgery 11. Supportive partner willing to complete sexual survey questionnaire (Appendix D) 12. 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. 13. Patient need cardiac clearance by the cardiologist Exclusion Criteria: 1. Penile anatomical abnormalities (Peyronie's disease) 2. Hypogonadism 3. Any medication used for androgen ablation (e.g., LHRH agonist or antagonist, anti-androgens, etc.) 4. 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 5. Previous or current hormonal treatment, chemotherapy, radiation therapy, immunotherapy or another investigational drug. 6. Any previous penile implant or penile vascular surgery 7. Injections of Trimix (combination of alprostadil, papaverine and phentolamine) pre and post-surgery . \-

Study sites (1)

TX