Umbilical Cord-Derived Mesenchymal Stem Cell (VCELL 1) for Male Patients With Sexual Deficiency

Launched by VINMEC RESEARCH INSTITUTE OF STEM CELL AND GENE TECHNOLOGY · Apr 20, 2022

Keywords

ClinConnect Summary

This clinical trial, called VCELL 1, is studying the use of special cells derived from umbilical cords, known as mesenchymal stem cells (MSCs), to help men aged 50 to 70 who have sexual hormone deficiencies. Sexual dysfunction can greatly affect a man's quality of life, and this trial aims to see if these stem cells can improve sexual function and hormone levels safely. The researchers have already seen positive results in earlier studies, where patients reported increased sexual satisfaction and higher testosterone levels after receiving these cells.

To participate in this trial, you need to be a man between 50 and 70 years old with specific symptoms of hormone deficiency, such as a low score on sexual health questionnaires and low testosterone levels. You also need to be generally healthy, without serious conditions like cancer or severe heart issues. If you qualify and decide to join, you'll receive the stem cell treatment and be monitored over time to assess its effects on your sexual function and hormone levels. It's important to note that you cannot be taking certain medications or have specific health issues to ensure your safety during the trial.

Gender

MALE

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.