Study: NCT04876326

Intervention type: BIOLOGICAL
Group type: ACTIVE_COMPARATOR
Intervention: Autologous Adipose Mesenchymal Stem Cell Implantation
Description: Before taking adipose tissue, each subject was screened including HbSAg, Anti HbS, Anti HCV, HIC, MCV and syphilis tests.~Adipose tissue was taken through 5 grams of subcutaneous fat biopsy from the abdomen of each subject and put into a transport medium and then sent to the RSCM-FKUI cGMP IPT Stem Cells Laboratory for immediate isolation of mesenchymal stem cells.~MSC that has been isolated will be cultured using the appropriate medium until it reaches the desired passage and the number of cells.~The viability and proliferation ability of cultured cells were evaluated, then characterization of cell antigen expression was carried out using flow cytometry to confirm the success of MSC culture.~The MSC to be injected into the subject will be prepared in 2cc physiological NaCl transport medium just before implantation.~The adipose secretion used is prepared in whole form as much as 10cc in a 10cc syringe.

Intervention type: BIOLOGICAL
Group type: ACTIVE_COMPARATOR
Intervention: Allogeneic Umbilical Cord Mesenchymal Stem Cell Implantation
Description: Before taking the umbilical cord tissue, a pregnant woman's donor was screened including HbSAg, Anti HbS, Anti HCV, HIC, MCV and syphilis tests.~Immediately after delivery, the umbilical cord was collected and stored in a sterile specimen plate containing 0.9% NaCl at 4⁰C.~The umbilical cord is transported to the GMP standard culture laboratory at the UPT TK Stem Cells RSCM-FKUI for isolation process of mesenchymal stem cells. Sample processing was carried out within 8 hours of delivery to maintain cell viability.~MSC that has been isolated will be cultured using the appropriate medium until it reaches the desired passage and the number of cells.~The viability and proliferation ability of cultured cells were evaluated, then characterization of cell antigen expression was carried out using flow cytometry to confirm the success of MSC culture.~The MSC to be injected into the subject will be prepared in a suitable transport medium just prior to implantation.

Intervention type: BIOLOGICAL
Group type: ACTIVE_COMPARATOR
Intervention: Allogeneic Umbilical Cord Mesenchymal Stem Cell and Adipose Secretome Implantation
Description: Before taking adipose and umbilical cord tissue, each subject was screened. -For Adipose tissue : The adipose secretion used is prepared in whole form as much as 10cc in a 10cc syringe.~-Uc-MSC : Immediately after delivery, the umbilical cord was collected and stored in a sterile specimen plate containing 0.9% NaCl at 4⁰C.~The umbilical cord is transported to the GMP standard culture laboratory to have isolation process of mesenchymal stem cells. Sample processing was carried out within 8 hours of delivery to maintain cell viability.~Later it will be cultured using the appropriate medium until it reaches the desired passage and the number of cells.The viability and proliferation ability of cultured cells were evaluated, then characterization of cell antigen expression was carried out using flow cytometry to confirm the success of MSC culture.