50
Participants
Start Date
October 1, 2023
Primary Completion Date
February 28, 2025
Study Completion Date
June 30, 2025
Intravenous administration of Autologous, adipose-derived mesenchymal stem cells
"Patients in group A will receive two infusions of autologous, adipose-derived mesenchymal stem cells at day 0 and day 90 ± 14 at a dose of 10\^6 cells/kg.~Autologous, adipose-derived mesenchymal stem cells used in this study were harvested from autologous fat tissue through an enzyme method and expanded using our in-house optimized serum-free and xeno-free culture under a physiological oxygen concentration of 5%. For clinical use, cells at passage 3 will be harvested in 100 mL Ringer's lactate. Therapeutic ASC products must pass the following releasing criteria: (1) negative for bacteria, fungi and mycoplasma; (2) more than 90% viability; (3) expression of more than 95% positivity for CD105, CD73, and CD90 and less than 2% positivity for CD45, CD34, CD11b, CD19, and HLA-DR; and (4) endotoxin \<5 EU/kg. The patient will be infused with 1x106 cells/kg body weight within 60 minutes via the intravenous route."
RECRUITING
Vinmec Research Institute of Stem Cell and Gene Technology, Hanoi
RECRUITING
Vinmec Times City International Hospital, Hanoi
Vinmec Research Institute of Stem Cell and Gene Technology
OTHER