158
Participants
Start Date
April 1, 2022
Primary Completion Date
June 1, 2025
Study Completion Date
December 30, 2025
Umbilical Cord-Derived Mesenchymal Stem Cell for Male Patients with Sexual Deficiency
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.
RECRUITING
Vinmec Research Institute of Stem Cell and Gene Technology, Hanoi
Vinmec Research Institute of Stem Cell and Gene Technology
OTHER