Umbilical Cord-Derived Mesenchymal Stem Cell (VCELL 1) for Male Patients With Sexual Deficiency

PHASE1/PHASE2RecruitingINTERVENTIONAL
Enrollment

158

Participants

Timeline

Start Date

April 1, 2022

Primary Completion Date

June 1, 2025

Study Completion Date

December 30, 2025

Conditions
Sexual Dysfunction Male
Interventions
BIOLOGICAL

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.

Trial Locations (1)

100000

RECRUITING

Vinmec Research Institute of Stem Cell and Gene Technology, Hanoi

All Listed Sponsors
lead

Vinmec Research Institute of Stem Cell and Gene Technology

OTHER