Status:
RECRUITING
Umbilical Cord-Derived Mesenchymal Stem Cell (VCELL 1) for Male Patients With Sexual Deficiency
Lead Sponsor:
Vinmec Research Institute of Stem Cell and Gene Technology
Conditions:
Sexual Dysfunction Male
Eligibility:
MALE
50-70 years
Phase:
PHASE1
PHASE2
Brief Summary
Sexual functional deficiency affects largely the physical conditions, life and sexual quality of the patients. Hypogonadism affects about 4 to 5 million men in the US, and the incidence increases with...
Detailed Description
Sexual functional deficiency occurs at some point in life and becomes a problematic issue in middle-aged adulthood. Regenerative medicine, especially mesenchymal stem cell (MSC) transplantation, has d...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2025
Estimated Enrollment :
158 Patients enrolled
Trial Details
Trial ID
NCT05345418
Start Date
April 1 2022
End Date
December 30 2025
Last Update
June 4 2024
Active Locations (1)
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1
Vinmec Research Institute of Stem Cell and Gene Technology
Hanoi, Vietnam, 100000