Clinical trial NCT03346967: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Hormone Deficiency
Keywords: AD mesenchymal stem cells;sexual hormone deficiency
Lead sponsor: Vinmec Research Institute of Stem Cell and Gene Technology
Sponsor class: OTHER
First posted: 2017-11-20
Enrollment: 30
Sex: ALL
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: 30 patients with sexual hormone deficiency will be injected AD-MSCs
Primary purpose: TREATMENT

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 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

Primary outcomes:
measure: Serum levels of follicle-stimulating hormone (FSH), Anti-Mullerian Hormone (AMH) and estradiol (E2) for female and testosterone level for male
timeFrame: up to the 12-month period following treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Hanoi
country: Vietnam
facility: Vinmec Research Institute of Stem Cell and Gene Technology
Study officials:
affiliation: Vinmec Healthcare System
name: Liem Nguyen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.