Evaluation of Autologous Adipose Derived Mesenchymal Stem Cells (AD-MSCs) Therapy on Sexual Hormone Deficiency in the Middle-aged Patients: an Open-label, Single-group Clinical Trial
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Hormone Deficiency
- Sponsor
- Vinmec Research Institute of Stem Cell and Gene Technology
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Serum levels of follicle-stimulating hormone (FSH), Anti-Mullerian Hormone (AMH) and estradiol (E2) for female and testosterone level for male
- Status
- Completed
- Last Updated
- last year
Overview
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, Vietnam
Investigators
Eligibility Criteria
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; 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 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
Outcomes
Primary Outcomes
Serum levels of follicle-stimulating hormone (FSH), Anti-Mullerian Hormone (AMH) and estradiol (E2) for female and testosterone level for male
Time Frame: up to the 12-month period following treatment
Comparison between Serum levels of follicle-stimulating hormone (FSH), Anti-Mullerian Hormone (AMH) and estradiol (E2) for female and testosterone level for male at pre and post AD-MSCs therapy