Outcomes of Adipose Derived Mesenchymal Stem Cells on Sexual Hormone Deficiency

Study Overview
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Brief Summary
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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
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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

Official Title
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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

Conditions
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Hormone Deficiency

Intervention / Treatment
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* Combination Product: adipose-derived mesenchymal stem cells


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: 30 patients with sexual hormone deficiency will be injected AD-MSCs
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stem cell Administration for female patients<br>Single Intravenous Administration of Autologous Adipose-derived Mesenchymal Stem Cells with Dosage at 1 million cells per body-weight kilogram for female patients | Combination Product: adipose-derived mesenchymal stem cells<br>* 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<br>|
| Experimental: Stem cell Administration for male patients<br>Single Intravenous Administration of Autologous Adipose-derived Mesenchymal Stem Cells with Dosage at 1 million cells per body-weight kilogram for male patients | Combination Product: adipose-derived mesenchymal stem cells<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum levels of follicle-stimulating hormone (FSH), Anti-Mullerian Hormone (AMH) and estradiol (E2) for female and testosterone level for male | 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 | up to the 12-month period following treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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AD mesenchymal stem cells;sexual hormone deficiency