Outcomes of Adipose Derived Mesenchymal Stem Cells on Sexual Hormone Deficiency

Last updated: June 3, 2024
Sponsor: Vinmec Research Institute of Stem Cell and Gene Technology
Overall Status: Completed

Phase

1/2

Condition

N/A

Treatment

adipose-derived mesenchymal stem cells

Clinical Study ID

NCT03346967
VinmecRISCGT72
  • Ages 35-70
  • All Genders

Study Summary

The purpose of this study is to evaluate the safety and effectiveness of adipose derived mesenchymal stem cells (AD-MSCs) therapy on sexual hormone deficiency in the middle-aged patients

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age: 35 years to 70 years (Male) and from 35 years to menopause age (Female)

  • Male: decrease in libido, decrease in intercourse frequency, erectile dysfunction,Difficulty in concentration, testosterone level ≤ 12 nMol/dL

  • Female: reduced or absent menstruation after radiation exposure or chemotherapy; Hotflushes, excessive sweating, and anxiety, together with other symptoms associatedwith the menopause, AMH level ≤ 2 ng/ml and/or FSH level ≥ 10 mIU/ml.

  • Patients signed the informed consent form

Exclusion

Exclusion Criteria:

  • Surgery removal of endocrine glands

  • Abnormalities in the endrocrine glands

  • Hormone deficiency due to diabetes and other metabolic disorders

  • Active autoimmune diseases

  • Current usage of immunosuppressive drugs

  • Coagulation disorders

  • Allergy to anesthetic agents

  • Severe health conditions such as cancer, failure of heart, lung, liver or kidney

  • Active infections

Study Design

Total Participants: 30
Treatment Group(s): 1
Primary Treatment: adipose-derived mesenchymal stem cells
Phase: 1/2
Study Start date:
November 01, 2017
Estimated Completion Date:
March 30, 2020

Study Description

The purpose of this study is to evaluate the safety and efficiency of adipose-derived mesenchymal stem cells in 30 patients with sexual hormone deficiency at Vinmec International Hospital, Hanoi, Vietnam

Connect with a study center

  • Vinmec Research Institute of Stem Cell and Gene Technology

    Hanoi, 10000
    Vietnam

    Site Not Available

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