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

Primary Purpose

Hormone Deficiency

Status
Unknown status
Phase
Phase 1
Locations
Vietnam
Study Type
Interventional
Intervention
adipose-derived mesenchymal stem cells
Sponsored by
Vinmec Research Institute of Stem Cell and Gene Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hormone Deficiency focused on measuring AD mesenchymal stem cells;sexual hormone deficiency

Eligibility Criteria

35 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Vinmec Research Institute of Stem Cell and Gene TechnologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Stem cell Administration for female patients

Stem cell Administration for male patients

Arm Description

Single Intravenous Administration of Autologous Adipose-derived Mesenchymal Stem Cells with Dosage at 1 million cells per body-weight kilogram for female patients

Single Intravenous Administration of Autologous Adipose-derived Mesenchymal Stem Cells with Dosage at 1 million cells per body-weight kilogram for male patients

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
November 14, 2017
Last Updated
November 21, 2018
Sponsor
Vinmec Research Institute of Stem Cell and Gene Technology
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1. Study Identification

Unique Protocol Identification Number
NCT03346967
Brief Title
Outcomes of Adipose Derived Mesenchymal Stem Cells on Sexual Hormone Deficiency
Acronym
MSCSHD
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2018
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2017 (Actual)
Primary Completion Date
February 28, 2020 (Anticipated)
Study Completion Date
March 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vinmec Research Institute of Stem Cell and Gene Technology

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hormone Deficiency
Keywords
AD mesenchymal stem cells;sexual hormone deficiency

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Model Description
30 patients with sexual hormone deficiency will be injected AD-MSCs
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Stem cell Administration for female patients
Arm Type
Experimental
Arm Description
Single Intravenous Administration of Autologous Adipose-derived Mesenchymal Stem Cells with Dosage at 1 million cells per body-weight kilogram for female patients
Arm Title
Stem cell Administration for male patients
Arm Type
Experimental
Arm Description
Single Intravenous Administration of Autologous Adipose-derived Mesenchymal Stem Cells with Dosage at 1 million cells per body-weight kilogram for male patients
Intervention Type
Combination Product
Intervention Name(s)
adipose-derived mesenchymal stem cells
Intervention Description
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 Outcome Measure Information:
Title
Serum levels of follicle-stimulating hormone (FSH), Anti-Mullerian Hormone (AMH) and estradiol (E2) for female and testosterone level for male
Description
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
Time Frame
up to the 12-month period following treatment

10. Eligibility

Sex
All
Gender Based
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.
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Liem Nguyen, PhD
Phone
(+84 4) 3 974 3556
Ext
1420
Email
v.liemnt@vinmec.com
First Name & Middle Initial & Last Name or Official Title & Degree
Phuong Nguyen, MPH
Phone
(+84) 914740683
Email
hoangphuonghsph@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liem Nguyen, PhD
Organizational Affiliation
Vinmec Healthcare System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vinmec Research Institute of Stem Cell and Gene Technology
City
Hanoi
ZIP/Postal Code
10000
Country
Vietnam
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Phuong Nguyen, MPH
Phone
(+84)914740683
Email
hoangphuonghsph@gmail.com
First Name & Middle Initial & Last Name & Degree
Liem Nguyen, Prof

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28053944
Citation
Reed-Maldonado AB, Lue TF. The Current Status of Stem-Cell Therapy in Erectile Dysfunction: A Review. World J Mens Health. 2016 Dec;34(3):155-164. doi: 10.5534/wjmh.2016.34.3.155. Epub 2016 Dec 22.
Results Reference
result
PubMed Identifier
27077129
Citation
Haahr MK, Jensen CH, Toyserkani NM, Andersen DC, Damkier P, Sorensen JA, Lund L, Sheikh SP. Safety and Potential Effect of a Single Intracavernous Injection of Autologous Adipose-Derived Regenerative Cells in Patients with Erectile Dysfunction Following Radical Prostatectomy: An Open-Label Phase I Clinical Trial. EBioMedicine. 2016 Jan 19;5:204-10. doi: 10.1016/j.ebiom.2016.01.024. eCollection 2016 Mar.
Results Reference
result
PubMed Identifier
25811565
Citation
Charles-de-Sa L, Gontijo-de-Amorim NF, Maeda Takiya C, Borojevic R, Benati D, Bernardi P, Sbarbati A, Rigotti G. Antiaging treatment of the facial skin by fat graft and adipose-derived stem cells. Plast Reconstr Surg. 2015 Apr;135(4):999-1009. doi: 10.1097/PRS.0000000000001123.
Results Reference
result
PubMed Identifier
34129158
Citation
Nguyen Thanh L, Dam PTM, Nguyen HP, Nguyen TT, To HM, Nguyen HB, Luu NA, Hoang DM. Can Autologous Adipose-Derived Mesenchymal Stem Cell Transplantation Improve Sexual Function in People with Sexual Functional Deficiency? Stem Cell Rev Rep. 2021 Dec;17(6):2153-2163. doi: 10.1007/s12015-021-10196-w. Epub 2021 Jun 15.
Results Reference
derived

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Outcomes of Adipose Derived Mesenchymal Stem Cells on Sexual Hormone Deficiency

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