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

  • STATUS
    Recruiting
  • End date
    Jun 30, 2024
  • participants needed
    158
  • sponsor
    Vinmec Research Institute of Stem Cell and Gene Technology
Updated on 4 October 2022

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 age. In our recent phase I clinical trial, we have shown that intravenous adipose - derived MSC administration was safe in female and male patients with hormone deficiency. Post-transplantation sexual satisfaction was observed in all patients enrolled in this study. Testosterone levels in males increased significantly after transplantation and were maintained at high levels for up to 6 months before decreasing again at the 12-month follow-up. The aim of this clinical trial was to assess the safety and effectiveness of allogeneic administration of MSCs in middle-aged people with sexual functional deficiency.

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 developed extensively, with preclinical and clinical trials emphasizing the benefits of stem cell therapy for restoration of sexual deficiency. n our recent phase I clinical trial, we have shown that intravenous adipose - derived MSC administration was safe in female and male patients with hormone deficiency. Post-transplantation sexual satisfaction was observed in all patients enrolled in this study. Testosterone levels in males increased significantly after transplantation and were maintained at high levels for up to 6 months before decreasing again at the 12-month follow-up. The aim of this clinical trial was to assess the safety and effectiveness of allogeneic administration of MSCs in middle-aged people with sexual functional deficiency. In phase II, 40 males with hormone deficiency will be recruited and divided randomly into two groups (n=23 each). The group A will receive UC-MSCs intravenously at day 0 and day 90 ± 7, while the group B will be infused with UC-MSCs at day 180 ± 14 and day 270 ± 14. Each group will be monitored for 365 ± 14 days after the first infusion. The phase II is to investigate safety and efficacy of UC-MSC infusion for the treatment of sexual hormone deficiency in males.

The primary outcome are: (1) numbers of AEs or SAEs during UC-MSC infusion and 365 ± 14 days after the first infusion; (2) Testosterone levels and sexual life quality through quantification of Aging Men Symptom (AMS), International Index of Erectile Function (IIEF), and Sexual Quality of Life Questionnaire (SQoL-M) at day 90 ± 7 and day 180 ± 14 of the group A compared to those of the group B.

The secondary outcome are: (1) Testosterone levels and (2) sexual life quality through quantification of AMS, IIEF, and SQoL-M at day 90 ± 7, day 180 ± 14, and day 365 ± 14 after the first UC-MSC infusion of each group compared to the baseline; (3) cytokine concentration (TNFa, IFN-γ, IL1, IL-6, IL-8, IL-4, IL-10, IDO) in serum of the participants and their T cell immunophenotype at day 90 ± 7, day 180 ± 14, and day 365 ± 14 after the first UC-MSC infusion.

Details
Condition Sexual Dysfunction Male
Treatment Umbilical Cord-Derived Mesenchymal Stem Cell for Male Patients with Sexual Deficiency
Clinical Study IdentifierNCT05345418
SponsorVinmec Research Institute of Stem Cell and Gene Technology
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

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
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