Actively Recruiting
Umbilical Cord-Derived Mesenchymal Stem Cell (VCELL 1) for Male Patients With Sexual Deficiency
Led by Vinmec Research Institute of Stem Cell and Gene Technology · Updated on 2024-06-04
158
Participants Needed
1
Research Sites
195 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Sexual functional deficiency affects largely the physical conditions, life and sexual quality of the patients. Hypogonadism affects about 4 to 5 million men in the US, and the incidence increases with age. In our recent phase I clinical trial, we have shown that intravenous adipose - derived MSC administration was safe in female and male patients with hormone deficiency. Post-transplantation sexual satisfaction was observed in all patients enrolled in this study. Testosterone levels in males increased significantly after transplantation and were maintained at high levels for up to 6 months before decreasing again at the 12-month follow-up. The aim of this clinical trial was to assess the safety and effectiveness of allogeneic administration of MSCs in middle-aged people with sexual functional deficiency.
CONDITIONS
Official Title
Umbilical Cord-Derived Mesenchymal Stem Cell (VCELL 1) for Male Patients With Sexual Deficiency
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male patients aged 50 to 70 years with sexual hormone deficiency
- AMS score of 27 or higher
- IIEF score less than 14
- SQoL-M score of 87 or less
- Testosterone level of 12 nMol/L or lower
- Normal liver function (ALT, AST, and Bilirubin within normal range)
- Normal kidney function according to Vietnamese biological indexes
- No infection with HIV, HBV, or active syphilis
- Able to provide written informed consent
You will not qualify if you...
- Previous surgery to remove gonads
- History of cancer, current cancer treatment, or positive cancer screening tests (PSA, AFP, Pepsinogen I and II, erythrocyte smear)
- Taking anti-rejection drugs
- Malformations or tumors of endocrine glands
- Endocrine problems from diabetes (HbA1c over 7) or other metabolic diseases
- Active autoimmune disease or positive antinuclear antibodies
- Severe heart, kidney, liver, or respiratory failure; history of stroke, heart attack, or Alzheimer’s disease
- Hypothyroidism
- Acute infection
- Significant blood clotting problems or other blood diseases
- Allergy to anesthetics, antibiotics, or related drugs
- Use of hormone-improving drugs or supplements (including Sildenafil) within last 2 weeks or planned use during study
- Current smoker
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Vinmec Research Institute of Stem Cell and Gene Technology
Hanoi, Vietnam, 100000
Actively Recruiting
Research Team
P
Phuong Nguyen, MSC
CONTACT
L
Liem Nguyen, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
OTHER
Number of Arms
2
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