---
title: Outcomes of Adipose Derived Mesenchymal Stem Cells on Sexual Hormone Deficiency
nct_id: NCT03346967
overall_status: COMPLETED
phase: PHASE1, PHASE2
sponsor: Vinmec Research Institute of Stem Cell and Gene Technology
study_type: INTERVENTIONAL
primary_condition: Hormone Deficiency
countries: Vietnam
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT03346967.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT03346967"
ct_last_update_post_date: 2024-06-04
last_seen_at: "2026-05-12T06:32:03.713Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Outcomes of Adipose Derived Mesenchymal Stem Cells on Sexual Hormone Deficiency

**Official Title:** 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

**NCT ID:** [NCT03346967](https://clinicaltrials.gov/study/NCT03346967)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE1, PHASE2
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 30
- **Lead Sponsor:** Vinmec Research Institute of Stem Cell and Gene Technology
- **Conditions:** Hormone Deficiency
- **Start Date:** 2017-11-01
- **Completion Date:** 2020-03-30
- **CT.gov Last Update:** 2024-06-04

## 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

## Eligibility

- **Minimum age:** 35 Years
- **Maximum age:** 70 Years
- **Sex:** ALL
- **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
```

## Arms

- **Stem cell Administration for female patients** (EXPERIMENTAL) — 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** (EXPERIMENTAL) — Single Intravenous Administration of Autologous Adipose-derived Mesenchymal Stem Cells with Dosage at 1 million cells per body-weight kilogram for male patients

## Interventions

- **adipose-derived mesenchymal stem cells** (COMBINATION_PRODUCT) — 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

## 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

## Locations (1)

- Vinmec Research Institute of Stem Cell and Gene Technology, Hanoi, Vietnam

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.vinmec research institute of stem cell and gene technology|hanoi||vietnam` — added _(2026-05-12)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT03346967*  
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