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

Vinmec Research Institute of Stem Cell and Gene Technology

Status and phase: Completed; Phase 2; Phase 1

Conditions: Hormone Deficiency

Treatments: Combination Product: adipose-derived mesenchymal stem cells

Study type: Interventional

Funder types: Other

Identifiers

NCT03346967

VinmecRISCGT72

Details and patient eligibility

About

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

Full 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

Enrollment: 30 patients

Sex: All

Ages: 35 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Stem cell Administration for female patients

Experimental group

Description:

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

Treatment:

Combination Product: adipose-derived mesenchymal stem cells

Stem cell Administration for male patients

Experimental group

Description:

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

Treatment:

Combination Product: adipose-derived mesenchymal stem cells