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Outcomes of Adipose Derived Mesenchymal Stem Cells on Sexual Hormone Deficiency (MSCSHD)

This study is currently recruiting participants.
Verified November 2017 by Vinmec Research Institute of Stem Cell and Gene Technology
Sponsor:
ClinicalTrials.gov Identifier:
NCT03346967
First Posted: November 20, 2017
Last Update Posted: November 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Vinmec Research Institute of Stem Cell and Gene Technology
  Purpose
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

Condition Intervention Phase
Hormone Deficiency Combination Product: adipose-derived mesenchymal stem cells Phase 2

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

Resource links provided by NLM:


Further study details as provided by Vinmec Research Institute of Stem Cell and Gene Technology:

Primary Outcome Measures:
  • 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


Estimated Enrollment: 30
Actual Study Start Date: November 1, 2017
Estimated Study Completion Date: December 30, 2018
Estimated Primary Completion Date: December 30, 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Stem cell Administration for female patients
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
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
Experimental: Stem cell Administration for male patients
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
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

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

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Gender Based Eligibility:   Yes
Gender Eligibility Description:  
  • 40 years to 65 years (Male) and from 40 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.
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age: 40 years to 65 years (Male) and from 40 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03346967


Contacts
Contact: Liem Nguyen, PhD (+84 4) 3 974 3556 ext 1420 v.liemnt@vinmec.com
Contact: Phuong Nguyen, MPH (+84) 914740683 hoangphuonghsph@gmail.com

Locations
Vietnam
Vinmec Research Institute of Stem Cell and Gene Technology Recruiting
Hanoi, Vietnam, 10000
Contact: Phuong Nguyen, MPH    (+84)914740683    hoangphuonghsph@gmail.com   
Principal Investigator: Liem Nguyen, Prof         
Sponsors and Collaborators
Vinmec Research Institute of Stem Cell and Gene Technology
Investigators
Principal Investigator: Liem Nguyen, PhD Vinmec International Hospital
  More Information

Publications:
Responsible Party: Vinmec Research Institute of Stem Cell and Gene Technology
ClinicalTrials.gov Identifier: NCT03346967     History of Changes
Other Study ID Numbers: VinmecRISCGT72
First Submitted: November 14, 2017
First Posted: November 20, 2017
Last Update Posted: November 20, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Vinmec Research Institute of Stem Cell and Gene Technology:
AD mesenchymal stem cells;sexual hormone deficiency

Additional relevant MeSH terms:
Endocrine System Diseases
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs