Hormone Deficiency
Conditions
Keywords
AD mesenchymal stem cells;sexual hormone deficiency
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
Interventions
COMBINATION_PRODUCTadipose-derived mesenchymal stem cells
Collect adipose-derived mesenchymal stem cells from the patients. Adipose-derived mesenchymal stem cells will be isolated, expanded and characterized in vitro under the GMP- grade procedure
Sponsors
Vinmec Research Institute of Stem Cell and Gene Technology
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
30 patients with sexual hormone deficiency will be injected AD-MSCs
Eligibility
Sex/Gender
ALL
Age
35 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Serum levels of follicle-stimulating hormone (FSH), Anti-Mullerian Hormone (AMH) and estradiol (E2) for female and testosterone level for male | 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 |
Countries
Vietnam
Outcome results
None listed