Vinmec Research Institute of Stem Cell and Gene Technology
Hanoi, 100000, Vietnam
NCT Number: NCT05517317
To evaluate the safety and early outcomes of autologous bone marrow mononuclear cell (BMMNC) infusion for liver cirrhosis due to biliary atresia (BA) after Kasai operation. An open-label clinical trial was performed from January 2015 to December 2021. 12 children with liver cirrhosis due to BA at the time of Kasai or after Kasai were included. Bone marrow was harvested through anterior iliac crest puncture under general anesthesia. Mononuclear cells (MNCs) were isolated by Ficoll gradient centrifugation and then infused into the hepatic artery.
Looking for future studies?
Notify Me2 month–15 year
All sexes
Interventional
Phase 1
Hanoi, 100000, Vietnam
Biliary atresia (BA) is a progressive fibro-obliterative cholangiopathy and a fatal disease. Without surgery, children with BA rarely survive beyond three years of age. The reported prevalence of BA ranges from 1 in 9640 to 1 in 19,500 live births. In the past, most children with a "non-correctable" type of BA died without adequate treatment. Recently, stem cell administration has been applied in adults with liver cirrhosis and has shown promising outcomes. An open-label clinical trial was performed from January 2015 to December 2021. 12 children with liver cirrhosis due to BA at the time of Kasai or after Kasai were included. Bone marrow was harvested through anterior iliac crest puncture under general anesthesia. Mononuclear cells (MNCs) were isolated by Ficoll gradient centrifugation and then infused into the hepatic artery. Serum bilirubin, albumin, alanine aminotransferase, aspartate aminotransferase, gamma-glutamyl transferase, and prothrombin time were monitored at baseline, three months, six months and 12 months after the transplantation. Esophagoscopies and liver biopsies were performed in patients whose parents provided consent. This study aimed to evaluate both safety and hepatic function after BMMNC administration in these children.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
One administration of autologous bone marrow mononuclear cells via the hepatic artery
Time frame: up to the 12-month period following treatment
To assess safety, the number of AEs or SAEs during stem cell administration (72 h) at 1 month, 3 months, 6 months, and 9 months after discharge will be evaluated
Time frame: up to the 12-month period following treatment
Using Total Bilirubin (units: mg/dL) to measure the changes in cholestasis
Time frame: up to the 12-month period following treatment
Using AST (Aspart transaminase) (units: U/L) to measure the changes in liver function.
Time frame: up to the 12-month period following treatment
Using ALT (Alanine transaminase) (units: U/L) to measure the changes in liver function.
Time frame: up to the 12-month period following treatment
Using GGT (Gamma GT) (units: U/L) to measure the changes in liver function.
Time frame: up to the 12-month period following treatment
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
Time frame: up to the 12-month period following treatment
Liver biopsy is a powerful clinical tool to evaluate the changes in the level of cirrhosis.
Vinmec Research Institute of Stem Cell and Gene Technology
Other
Autologous Bone Marrow Mononuclear Cell Infusion for Liver Cirrhosis in Children With Biliary Atresia
Acronym: ABMNCBA
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT04336722
Bile Duct Diseases, Biliary Atresia
Los Angeles, California, United States
View Trial DetailsNCT06184971
Bile Duct Diseases, Biliary Atresia
Hartford, Connecticut, United States
View Trial DetailsNCT07328204
Bile Duct Diseases, Biliary Atresia
Hangzhou, China
View Trial DetailsNCT04524390
Bile Duct Diseases, Biliary Atresia
Phoenix, Arizona, United States
View Trial Details