Clinical trial
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
Name
VinmecRISCGT72
Description
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
Trial arms
Trial start
2017-11-01
Estimated PCD
2020-02-28
Trial end
2020-03-30
Status
Completed
Phase
Early phase I
Treatment
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
Arms:
Stem cell Administration for female patients, Stem cell Administration for male patients
Size
30
Primary endpoint
Serum levels of follicle-stimulating hormone (FSH), Anti-Mullerian Hormone (AMH) and estradiol (E2) for female and testosterone level for male
up to the 12-month period following treatment
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1', 'PHASE2'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': '30 patients with sexual hormone deficiency will be injected AD-MSCs', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 30, 'type': 'ACTUAL'}}
Updated at
2024-06-04
1 organization
1 product
1 indication
Indication
Hormone Deficiency