Erectile DysfunctionPhase 1/2NCT07048314

Stem Cells for Erectile Dysfunction Post RALP

A Phase 1/2 study testing Allogeneic adipose-derived mesenchymal stem cells (HB-adMSCs) at the doctor's office and Allogeneic adipose-derived mesenchymal stem cells (HB-adMSCs) in the OR in people with Erectile Dysfunction and Prostate Cancer, run by The Methodist Hospital Research Institute at 1 site in United States.

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Sites and contacts

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 40 to 70 years, men only
Conditions the study is for: Erectile Dysfunction, Prostate Cancer
What is being tested?: Allogeneic adipose-derived mesenchymal stem cells (HB-adMSCs) at the doctor's office and Allogeneic adipose-derived mesenchymal stem cells (HB-adMSCs) in the OR
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 40 participants
Where: 1 siteUnited States
Study dates: 7 Jul 2026to 30 Jun 2027
Phase: Phase 1/2

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 to 70 years
Men only
No healthy volunteers
Adult, Older adult

Who may be able to join

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

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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

Who cannot join

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 .
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Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site, 1 recruiting

Houston Methodist
Houston, Texas, 77030
Vivian MacDonnell, CCRP, 713-441-8113, vmmacdonnell@houstonmethodist.org
Brian Miles, MD
Recruiting

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About this study

Official title: 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

Read the 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:

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)
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.

Conditions: Erectile Dysfunction, Prostate Cancer
Being tested: 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
Medical subject headings: Erectile Dysfunction, Prostatic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Allogeneic adipose-derived mesenchymal stem cells (HB-adMSCs) at the doctor's officeDrug
Also called HB-adMSCs
2.00x10⁸ HB-adMSCs IV at the doctor's office.
Allogeneic adipose-derived mesenchymal stem cells (HB-adMSCs) in the ORDrug
Also called HB-adMSCs
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 ORDrug
Also called Saline solution 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 clinicDrug
Also called Saline solution 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.

Study groups in NCT07048314
Study group	Role	What they receive
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. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: Placebo in the OR; Drug: Placebo in clinic

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: 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
Measured: 6 months

Secondary outcomes (1)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 Jul 202630 Jun 2027

First posted2 Jul 2025
Study start7 Jul 2026
Primary completion30 Jun 2027 (estimated)
Study completion30 Jun 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Erectile DysfunctionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 40 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07048314
Sponsor's protocol ID: Pro00039638
Status last verified: Jul 2026
First submitted: 24 Jun 2025
Last updated: 10 Jul 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

Interested in taking part?

Each site lists its own contact. Pick the site nearest to you.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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