Outcomes of Adipose Derived Mesenchymal Stem Cells on Sexual Hormone Deficiency

Phase 1

Completed

• Conditions: Hormone Deficiency
• Interventions: Combination Product: adipose-derived mesenchymal stem cells

• Registration Number: NCT03346967
• Lead Sponsor: Vinmec Research Institute of Stem Cell and Gene Technology

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

Study Timeline

• Study Start: 2017-11-01
• Study First Submitted: 2017-11-14
• Study First Submitted QC: 2017-11-14
• Study First Posted: 2017-11-20
• Primary Completion: 2020-02-28
• Study Completion: 2020-03-30
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-03
• Last Update Posted: 2024-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Stem cell Administration for female patients	adipose-derived mesenchymal stem cells	Single Intravenous Administration of Autologous Adipose-derived Mesenchymal Stem Cells with Dosage at 1 million cells per body-weight kilogram for female patients
Stem cell Administration for male patients	adipose-derived mesenchymal stem cells	Single Intravenous Administration of Autologous Adipose-derived Mesenchymal Stem Cells with Dosage at 1 million cells per body-weight kilogram for male patients

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Vinmec Research Institute of Stem Cell and Gene Technology; 🇻🇳 Hanoi, Vietnam