Using stem cells from umbilical cords to treat sexual dysfunction in men

Evaluation of the Safety and Efficacy of Umbilical Cord-Derived Mesenchymal Stem Cell (VCELL 1) for Male Patients With Sexual Deficiency: A Phase I/IIa Randomised Crossover Trial

This study is testing if stem cells from umbilical cords can help middle-aged men with sexual dysfunction feel better and improve their hormone levels.

Quick facts

• Phase: Phase1; Phase2
• Study type: Interventional
• Enrollment: 158 (estimated)
• Ages: 50 Years to 70 Years
• Sex: Male
• Sponsor: Vinmec Research Institute of Stem Cell and Gene Technology (Academic / other)
• Locations: 1 site (Hanoi)
• Trial ID: NCT05345418 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the safety and effectiveness of umbilical cord-derived mesenchymal stem cells (UC-MSCs) in treating sexual hormone deficiency in middle-aged men. Participants aged 50 to 70 with confirmed sexual dysfunction will be randomly assigned to receive UC-MSC infusions at different intervals. The study will monitor the participants for a year to assess changes in sexual satisfaction and testosterone levels. Previous trials have indicated that stem cell therapy can improve hormone levels and sexual satisfaction in patients with similar conditions.

Who should consider this trial

Good fit: Ideal candidates are males aged 50 to 70 with diagnosed sexual hormone deficiency and specific scoring criteria.

Not a fit: Patients with a history of cancer, autoimmune diseases, or those who have undergone gonad removal may not benefit from this treatment.

Why it matters

Potential benefit: If successful, this treatment could significantly improve sexual function and quality of life for men suffering from hormone deficiencies.

How similar studies have performed: Previous studies have shown promising results with stem cell therapies for hormone deficiencies, indicating potential for success in this approach.

Eligibility criteria

Inclusion Criteria:

* Males with sexual hormone deficiency aged 50 to 70 years
* AMS score ≥ 27
* IIEF \< 14
* SQoL-M ≤ 87
* and Testosterone ≤ 12 nMol/L
* Normal liver function (ALT, AST and Bilirubin are normal according to biological index of Vietnamese people).
* Normal kidney function is usually according to the biological index of Vietnamese people.
* No infection, HIV, HBV, active syphilis.
* Must provide written informed consent.

Exclusion Criteria:

* The patient had surgery to remove the gonads.
* Patients with a history of cancer, or undergoing cancer treatment, or are positive for cancer screening tests including: PSA, AFP, Pepsinogen I, Pepsinogen II and erythrocyte smear test.

The patient is taking anti-rejection drugs.

* Patients with malformations, malformations or tumors of the endocrine glands.
* Endocrine impairment due to diabetes (HBA1c \> 7) and other metabolic diseases.
* Patients with active autoimmune disease or positive for antinuclear antibodies.
* Patients with severe heart failure, severe renal failure, severe liver failure, severe respiratory failure, history of cerebral infarction, myocardial infarction, Alzeimer.
* Patients with hypothyroidism.
* The patient has an acute infection.
* Patients with clinically significant coagulopathy or other hematological diseases.
* History of allergy to anesthetics, anesthetics, antibiotics.
* Patients who are using other hormone-improving drugs or supplements (including Sildenafil) in the last 2 weeks or want to continue using these drugs during the study period.
* The patient is a smoker.

Where this trial is running

Hanoi

• Vinmec Research Institute of Stem Cell and Gene Technology — Hanoi, Vietnam (Recruiting)

Study contacts

• Principal investigator: Tan Sinh Nguyen, Dr — Vinmec Times City International Hospitalme
• Study coordinator: Phuong Nguyen, MSC

Conditions Sexual Dysfunction Male; reproductive hormones; mesenchymal stem Cell