Recruiting
Phase 1
Phase 2

HB-adMSCs

Sponsor:

The Methodist Hospital Research Institute

Code:

NCT07048314

Conditions

Erectile Dysfunction

Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 40 - 70

Healthy Volunteers: Not accepted

Interventions

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

Study Details

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

Erectile Dysfunction

Prostate Cancer

Study ID

NCT07048314

Start date

Jul 7, 2026

Status verified date

Jul, 2026

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 40 - 70

Healthy Volunteers: Not accepted

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 .

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Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Factorial

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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

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.

experimental: 2: Placebo plus allogeneic adipose-derived mesnchymal stem cells

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.

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

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.

placebo comparator: 4: placebo plus placebo

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.

Interventions

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

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

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

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

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

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.

Primary outcome measure

  • Change in erectile function by IIEF [ Time Frame: from baseline to 6 months post treatment ]
  • Change in erectile function by Epic 26 [ Time Frame: 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) [ Time Frame: 6 months ]

Central Contacts and Locations

Locations

Houston Methodist

Recruiting

Houston, Texas, United States, 77030

Contacts

Vivian MacDonnell, CCRP

713-441-8113vmmacdonnell@houstonmethodist.org

Principal Investigator:

Brian Miles, MD

More Information

Sponsor

The Methodist Hospital Research Institute

Last update posted

Jul 10, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The Methodist Hospital Research Institute on 2026-07-10.