Outcomes of Adipose Derived Mesenchymal Stem Cells on Sexual Hormone Deficiency

Hormone Deficiency Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03346967
• Other study ID #: VinmecRISCGT72
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: November 1, 2017
• Est. completion date: March 30, 2020

Study information

• Verified date: June 2024
• Source: Vinmec Research Institute of Stem Cell and Gene Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: March 30, 2020
• Est. primary completion date: February 28, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Endocrine System Diseases
• Hormone Deficiency

Intervention

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

Locations

Country	Name	City	State
Vietnam	Vinmec Research Institute of Stem Cell and Gene Technology	Hanoi

Sponsors (1)

Lead Sponsor	Collaborator
Vinmec Research Institute of Stem Cell and Gene Technology

Country where clinical trial is conducted

Vietnam, 

References & Publications (3)

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: 10.109 — View 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 R — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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