A Phase 2 interventional study of Autologous BMMC transplantation in Liver Cirrhosis, Biliary, sponsored by Vinmec Research Institute of Stem Cell and Gene Technology. Completed at 2 sites in Vietnam. Open to participants aged 1 Year to 15 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-06-04.
Sponsored by Vinmec Research Institute of Stem Cell and Gene Technology · Phase 2, Interventional, and Treatment
The aim of this study was to evaluate the safety and effectiveness of autologous bone marrow mononuclear stem cell transplantation for Children Suffering from Liver Cirrhosis Due to Biliary Atresia
This study is ferformed to evaluate the safety and effectiveness of autologous bone marrow mononuclear stem cell transplantation in the management of Liver Cirrhosis Due to Biliary Atresia after Kasai's operation of 20 patients at Vinmec Research Institute of Stem Cell and Gene Technology, Hanoi, Vietnam from January 2017 to December 2018
214 studies on the registry are indexed under Liver Cirrhosis, Biliary; 48 are open to participants now.
This study's enrollment of 17 is below the median of 60 across 151 interventional studies indexed under Liver Cirrhosis, Biliary.
Browse Liver Cirrhosis, Biliary studies →Vinmec Research Institute of Stem Cell and Gene Technology is the lead sponsor of 28 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Stem cell transplantations include 2 administrations of autologous bone marrow mononuclear cells via the hepatic artery at baseline and 6 months afterward
Combination Product: Autologous BMMC transplantation
Stem cell transplantation
Assess the changes in cholestasis
Using Bilirubin (total, direct and indirect) (units: mg/dL) to measure the changes in cholestasis
Time frame: Baseline, 3, 6 months and 12 months after transplantation
Assess the changes in Liver function
Using AST (Aspart transaminase) and ALT (Alanin transaminase) (units: U/L), GGT (Gamma GT) (units: UI/L), and Bilirubin (units: mg/dL) to measure the changes in Liver function
Time frame: Baseline, 3, 6 months and 12 months after transplantation
Assess the changes in level of cirrhosis
Using PELD score (according to the suggestion of The Liver and Intestinal Organ Transplantation Committee in 2009). PELD is calculated based on three indicators: albumin (g / dL), bilirubin (units: mg / dL) and INR (international normalized ratio). Formula: PELD = 10 \* (0.48 \* ln(Serum Bilirubin) + 1.857 \* ln(INR) - 0.687 \* ln(Albumin) + (0.436 if patient is less than 1 year old) + (0.667 if patient has growth failure)). Evaluate the result: * If PELD \<10: good results * If 10 \<PELD \<15: average results * If PELD\> 15: bad results Albumin (Unit: g / dL), bilirubin (units: mg / dL) and INR (international normalized ratio).
Time frame: Baseline, 3, 6 months and 12 months after transplantation
Assess the changes in liver biopsy
Liver biopsy, in combination with history and physical examination data, is a powerful clinical tool for diagnosing and treating liver disease to evaluate the changes in liver biopsy
Time frame: Baseline, 3, 6 months and 12 months after transplantation
This study is completed, as verified in Jun 2024. You cannot join it, but the record below documents what was studied.
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Vinmec Research Institute of Stem Cell and Gene Technology