Stem Cells for Erectile Dysfunction Post RALP

Part of paid clinical trials in Houston, Texas.

Sponsor
The Methodist Hospital Research Institute
Study ID
NCT07048314
Phase
PHASE1/PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
MALE
Age
40 Years - 70 Years
Healthy Volunteers
Not accepted

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.
  • 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
  • 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 .
  • 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.

Study Details

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.

Key Dates

Start date
Mar 10, 2026
Status verified
Mar 2026
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

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

Locations (1)

FacilityCityStateZIPSite coordinators
Houston MethodistHoustonTexas77030-

Find similar trials in Houston, TX

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
Houston Methodist· Houston, TX

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