Stem Cells for Erectile Dysfunction Post RALP

NCT ID: NCT07048314

Last Updated: 2025-07-02

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-01
• Study Completion Date: 2027-06-30

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.

Conditions

Erectile Dysfunction; Prostate Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

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

Intervention Type: 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

Placebo in clinic

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

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

Placebo in the OR

Intervention Type: 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 .

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.

Group Type: EXPERIMENTAL

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

Intervention Type: DRUG

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

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

Intervention Type: 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

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.

Group Type: PLACEBO_COMPARATOR

Placebo in the OR

Intervention Type: 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 .

Placebo in clinic

Intervention Type: 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.

Interventions

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

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

Intervention Type: DRUG

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

Intervention Type: DRUG

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 .

Intervention Type: DRUG

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.

Intervention Type: DRUG

Other Intervention Names

HB-adMSCs; HB-adMSCs; Saline solution in the OR; Saline solution in clinic

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 .

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• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

The Methodist Hospital Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Brian Miles

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Houston Methodist

Houston, Texas, United States

Countries

United States

Other Identifiers

Pro00039638

Identifier Type: -

Identifier Source: org_study_id