Status:

COMPLETED

Outcomes of Adipose Derived Mesenchymal Stem Cells on Sexual Hormone Deficiency

Lead Sponsor:

Vinmec Research Institute of Stem Cell and Gene Technology

Conditions:

Hormone Deficiency

Eligibility:

All Genders

35-70 years

Phase:

PHASE1

PHASE2

Brief 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

Detailed 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, Viet...

Eligibility Criteria

Inclusion

  • 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; Hot flushes, excessive sweating, and anxiety, together with other symptoms associated with the menopause, AMH level ≤ 2 ng/ml and/or FSH level ≥ 10 mIU/ml.
  • Patients signed the informed consent form

Exclusion

  • 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

Key Trial Info

Start Date :

November 1 2017

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

March 30 2020

Estimated Enrollment :

30 Patients enrolled

Trial Details

Trial ID

NCT03346967

Start Date

November 1 2017

End Date

March 30 2020

Last Update

June 4 2024

Active Locations (1)

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Vinmec Research Institute of Stem Cell and Gene Technology

Hanoi, Vietnam, 10000