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NCT05517317: ABMNCBA
Autologous BMNC Infusion for Liver Cirrhosis in Children With BA
Phase 1 trial testing Autologous BMMC transplantation in Biliary Atresia in 12 participants. Completed in 30 May 2022.
30 May 2022
Quick facts
| Lead sponsor | Vinmec Research Institute of Stem Cell and Gene Technology |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 12 |
| Start date | 1 January 2015 |
| Primary completion | 30 May 2022 |
| Estimated completion | 30 May 2022 |
| Sites | 1 location across Vietnam |
Drugs / interventions tested
- Autologous BMMC transplantation
Conditions studied
- Biliary Atresia — all drugs for Biliary Atresia →
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):
-
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 -
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 -
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 -
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:
- PubMed search for NCT05517317
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Autologous BMMC transplantation
Trials testing the same drug.
- NCT03468699 — Autologous Bone Marrow Mononuclear Stem Cell for Children Suffering From Liver Cirrhosis Due to Biliary Atresia · Phase 2 · completed
Other recruiting trials for Biliary Atresia
Currently open trials in the same condition.
- NCT06764082 — Nutritional Intervention for Biliary Atresia · NA · recruiting
- NCT06564740 — Stem Cell Applications in Biliary Atresia Patients · NA · recruiting
- NCT05925309 — Preventive Effect of Prophylactic Oral Antibiotics Against Cholangitis After Kasai Portoenterostomy · NA · recruiting
- NCT05072626 — High Medium-chain Triglyceride Nutritional Support in Infants With Biliary Atresia · recruiting
- NCT04272515 — Molecular Characterization for Understanding Biliary Atresia · NA · recruiting
Other Vinmec Research Institute of Stem Cell and Gene Technology trials
Trials by the same sponsor.
- NCT07472270 — Safety Evaluation of MSC-based Therapy for Liver Cihcrosis Treatment · Phase 1 · not yet recruiting
- NCT06629324 — Evaluating Bone Marrow Cell Transplant for Treating Cerebral Palsy From Brain Hypoxia · Phase 2 · recruiting
- NCT06726538 — Investigating the Efficacy of Autologous, Adipose-derived Mesenchymal Stem Cell Therapy for the Treatment of Sexual Func · Phase 1, PHASE2 · completed
- NCT06027957 — CD19 CAR T-Cell Therapy for R/R Non-Hodgkin Lymphoma and Acute Lymphoblastic Leukemia · Phase 1 · completed
- NCT05329662 — Adipose Tissue-derived Mesenchymal Stem Cell (AD-MSC) Therapy for the Treatment of Sexual Function Impairment in Female · Phase 2 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05517317 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Vinmec Research Institute of Stem Cell and Gene Technology
- Last refreshed: 26 August 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05517317.
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