Stem Cells for Erectile Dysfunction Post RALP

Not Applicable

Not yet recruiting

• Conditions: Erectile Dysfunction; Prostate Cancer

• Registration Number: NCT07048314
• Lead Sponsor: The Methodist Hospital Research Institute

Brief Summary

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.

Detailed Description

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 Timeline

• Status Verified: 2025-06
• Study First Submitted: 2025-06-24
• Study First Submitted QC: 2025-06-24
• Last Update Submitted: 2025-06-24
• Study Start: 2025-07-01
• Study First Posted: 2025-07-02
• Last Update Posted: 2025-07-02
• Primary Completion: 2027-06-30
• Study Completion: 2027-06-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Male
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Primary Outcome Measures

Name	Time	Method
Change in erectile function by IIEF	from baseline to 6 months post treatment	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.
Change in erectile function by Epic 26	from baseline to 6 months post treatment	This questionnaire is designated to measure Quality of Life issues.Clinical relevance (\>12 points) for sexual function domain score as measured by EPIC-26.
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)	6 months	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

Secondary Outcome Measures

Name	Time	Method
Change in urinary function	from baseline to 6 months post treatment	This questionnaire is designated to measure Quality of Life issues.Clinically relevant (≥9 points) difference in the EPIC-26 urinary incontinence domain score

Trial Locations

Locations (1)

Houston Methodist; 🇺🇸 Houston, Texas, United States