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NCT05517317: ABMNCBA

Autologous BMNC Infusion for Liver Cirrhosis in Children With BA

Completed Phase 1 Last updated 26 August 2022
What this trial tests

Phase 1 trial testing Autologous BMMC transplantation in Biliary Atresia in 12 participants. Completed in 30 May 2022.

Timeline
1 January 2015
Primary endpoint
30 May 2022
30 May 2022

Quick facts

Lead sponsorVinmec Research Institute of Stem Cell and Gene Technology
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment12
Start date1 January 2015
Primary completion30 May 2022
Estimated completion30 May 2022
Sites1 location across Vietnam

Drugs / interventions tested

Conditions studied

Sponsor

Vinmec Research Institute of Stem Cell and Gene Technology

Who can join

Adults 2 Months to 15, any sex, with Biliary Atresia. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

4 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Biliary fibrosis is an important but neglected pathological feature in hepatobiliary disorders: from molecular mechanisms to clinical implications.
    Zhao J, Yue P, Mi N, Li M, et al · · 2024 · cited 5× · PMID 39135601 · DOI 10.1515/mr-2024-0029
  2. Modified Kasai operation combined with autologous bone marrow mononuclear cell infusion for biliary atresia.
    Thanh LN, Nguyen HP, Kieu TPT, Duy MN, et al · · 2024 · cited 3× · PMID 39568009 · DOI 10.1186/s12893-024-02669-9
  3. Magnetic Nanostructures and Stem Cells for Regenerative Medicine, Application in Liver Diseases.
    Barreto da Silva T, Dias EA, Cardoso LMDF, Gama JFG, et al · · 2023 · cited 1× · PMID 37298243 · DOI 10.3390/ijms24119293
  4. Modified Kasai operation combined with autologous bone marrow mononuclear cell infusion for biliary atresia
    Nguyen T, Nguyen H-P, Phan TKT, Ngo DM, et al · · 2023 · DOI 10.21203/rs.3.rs-3357053/v1

Verify or expand the search:

Other trials of Autologous BMMC transplantation

Trials testing the same drug.

Other recruiting trials for Biliary Atresia

Currently open trials in the same condition.

Other Vinmec Research Institute of Stem Cell and Gene Technology trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing