Stem Cells for Erectile Dysfunction Post RALP

NCT07048314 | Not Yet Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: Pro00039638
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer; Erectile Dysfunction

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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

  6 months

Secondary Outcomes (1)

• Change in urinary function

  from baseline to 6 months post treatment

Study Arms (4)

1: allogeneic adipose-derived mesnchymal stem cells plus saline solution

EXPERIMENTAL

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.

Drug: Allogeneic adipose-derived mesenchymal stem cells (HB-adMSCs) in the OR; Drug: Placebo in clinic

2: Placebo plus allogeneic adipose-derived mesnchymal stem cells

EXPERIMENTAL

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 in the OR at week 1 plus 2.00x 10⁸ HB-adMSCs via IV in clinic at week 12.

Drug: Allogeneic adipose-derived mesenchymal stem cells (HB-adMSCs) at the doctor's office; Drug: Placebo in the OR

3: allogeneic adipose-derived mesnchymal stem cells intra op and at week 12 in clinic

EXPERIMENTAL

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.

Drug: Allogeneic adipose-derived mesenchymal stem cells (HB-adMSCs) at the doctor's office; Drug: Allogeneic adipose-derived mesenchymal stem cells (HB-adMSCs) in the OR

4: placebo plus placebo

PLACEBO COMPARATOR

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 in the OR at week 1 plus saline solutin via IV in clinic at week 12.

Drug: Placebo in the OR; Drug: Placebo in clinic

Interventions

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

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

Also known as: HB-adMSCs

2: Placebo plus allogeneic adipose-derived mesnchymal stem cells; 3: allogeneic adipose-derived mesnchymal stem cells intra op and at week 12 in clinic

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

Also known as: HB-adMSCs

1: allogeneic adipose-derived mesnchymal stem cells plus saline solution; 3: allogeneic adipose-derived mesnchymal stem cells intra op and at week 12 in clinic

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 .

Also known as: Saline solution in the OR

2: Placebo plus allogeneic adipose-derived mesnchymal stem cells; 4: placebo plus placebo

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.

Also known as: Saline solution in clinic

1: allogeneic adipose-derived mesnchymal stem cells plus saline solution; 4: placebo plus placebo

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Pre-op IIEF-5 \>20 (Appendix A)
• Testosterone serum: \> 300ng/dl with normal Free Testosterone
• Life expectancy of at least 10 years
• Performance status of ≤ 2 (Zubrod scale). (Appendix B)
• 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
• Patient is willing to attempt intercourse at least 5 times per month following urinary control after surgery
• Supportive partner willing to complete sexual survey questionnaire (Appendix D)
• 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.
• Patient need cardiac clearance by the cardiologist

You may not qualify if:

• 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
• Previous or current hormonal treatment, chemotherapy, radiation therapy, immunotherapy or another investigational drug.
• Any previous penile implant or penile vascular surgery
• Injections of Trimix (combination of alprostadil, papaverine and phentolamine) pre and post-surgery .

Sponsors & Collaborators

• The Methodist Hospital Research Institute: lead

Study Sites (1)

Houston Methodist

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Erectile Dysfunction; Prostatic Neoplasms

Interventions

Saline Solution; Ambulatory Care Facilities

Condition Hierarchy (Ancestors)

Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Prostatic Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Health Facilities; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: June 24, 2025
• First Posted: July 2, 2025
• Study Start: March 10, 2026
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: March 19, 2026

Record last verified: 2026-03

Locations

US (1)