Umbilical Cord-Derived Mesenchymal Stem Cell (VCELL 1) for Male Patients With Sexual Deficiency
Evaluation of the Safety and Efficacy of Umbilical Cord-Derived Mesenchymal Stem Cell (VCELL 1) for Male Patients With Sexual Deficiency: A Phase I/IIa Randomised Crossover Trial
Vinmec Research Institute of Stem Cell and Gene Technology
158 participants
Apr 1, 2022
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria9
- Males with sexual hormone deficiency aged 50 to 70 years
- AMS score ≥ 27
- IIEF < 14
- SQoL-M ≤ 87
- and Testosterone ≤ 12 nMol/L
- Normal liver function (ALT, AST and Bilirubin are normal according to biological index of Vietnamese people).
- Normal kidney function is usually according to the biological index of Vietnamese people.
- No infection, HIV, HBV, active syphilis.
- Must provide written informed consent.
Exclusion Criteria13
- The patient had surgery to remove the gonads.
- Patients with a history of cancer, or undergoing cancer treatment, or are positive for cancer screening tests including: PSA, AFP, Pepsinogen I, Pepsinogen II and erythrocyte smear test.
- The patient is taking anti-rejection drugs.
- Patients with malformations, malformations or tumors of the endocrine glands.
- Endocrine impairment due to diabetes (HBA1c > 7) and other metabolic diseases.
- Patients with active autoimmune disease or positive for antinuclear antibodies.
- Patients with severe heart failure, severe renal failure, severe liver failure, severe respiratory failure, history of cerebral infarction, myocardial infarction, Alzeimer.
- Patients with hypothyroidism.
- The patient has an acute infection.
- Patients with clinically significant coagulopathy or other hematological diseases.
- History of allergy to anesthetics, anesthetics, antibiotics.
- Patients who are using other hormone-improving drugs or supplements (including Sildenafil) in the last 2 weeks or want to continue using these drugs during the study period.
- The patient is a smoker.
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Interventions
Patients will receive two administrations at a dose of 1.5 million cells/kg patient bodyweight via the IV route with a 3-month intervening interval. A validated umbilical cord blood mesenchymal stem cells (UC-MSC) line was selected from the Vinmec Tissue Bank and cultured under xeno-free, serum-free and antibiotic-free conditions as previously described. To prepare UC-MSCs for therapy, aliquots of Passage 3 (P3) UC-MSCs will be thawed and cultured to P5 to get approximately 500 million cells and dispensed to 10 million UC-MSCs/ml/vial for cryopreservation. Upon request from the clinical team, aliquots of P5 UC-MSCs will be thawed in a temperature control water bath or incubator on the infusion day. The UC-MSCs will be washed and suspended in Ringer Lactate.
Locations(1)
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NCT05345418