Efficacy and Safety of BMSCs (CG-BM1) for ACLF Patients
NCT ID: NCT06740149
Last Updated: 2024-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
90 participants
INTERVENTIONAL
2023-03-01
2026-01-31
Brief Summary
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* To evaluate the safety and tolerability of CG-BM1 for the treatment of adult patients with ACLF.
* To observe the preliminary effectiveness of CG-BM1 in treating adult ACLF patients, and to provide a basis for subsequent clinical trial protocol design.
Detailed Description
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The study was divided into 2 phases, the first with an open-labeled, dose-escalation design; the second with a multicenter, randomized, double-blind, placebo-controlled design. Phase I: Patients was divided into three dose groups using a traditional "3+3" design. 3-6 subjects were enrolled in each dose. Phase II: Multiple-dose, randomized, double-blind, placebo-controlled trial. Based on the results of the phase I trial, two dose groups were selected for phase II.
A total of 90 subjects were enrolled and randomized 1:1:1. The experiment group received CG-BM1 + conventional treatment regimen, and the control group received placebo + conventional treatment regimen.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Phase 2: Placebo Control
The control group received placebo + conventional treatment. Placebo was solubilizer of CG-BM1. Conventional treatment included hepatoprotection, antiviral therapy or other etiologic treatments, supplementation of plasma and albumin, supplementation of coagulation factors, treatment of complications, and nutritional support.
Solvent of CG-BM1
Administered intravenously, once a week for a total of 4 doses.
Phase 2: Low Dose Group
Patients in low dose group receive CG-BM1 + conventional treatment. Administration procedure of CG-BM1 is 1.0×10\^6 cells/kg CG-BM1 once a week for a total of 4 administrations.
Bone marrow mesenchymal stem cells (low dose)
Administered intravenously. For phase I: single infusion, 1.0×10\^6 cells/kg. For phase II: 1.0×10\^6 cells /kg once a week for a total of 4 times.
Phase 2: Medium Dose Group
Patients in medium dose group receive CG-BM1 + conventional treatment. Administration procedure of CG-BM1 is 2.0×10\^6 cells/kg CG-BM1 once a week for a total of 4 administrations.
Bone marrow mesenchymal stem cells (medium dose)
Administered intravenously. For phase I: single infusion, 2.0×10\^6 cells /kg. For phase II: 2.0×10\^6 cells /kg once a week for a total of 4 times.
Phase 1: Low Dose Group
The trial group with a low dose (1.0×10\^6 cells/kg) will first enroll one subject, who will be infused with single dose CG-BM1 and then observed for at least 28 days. The clinical data of the first subject will be reviewed by the SRC.
* If the first subject in the low-dose trial group experiences DLT, enrollment will be suspended. After discussion, recommendations will be made. If the trial is to continue, two additional subjects will be enrolled for observation. If no DLT occurs, the dose trial group will need to enroll three more subjects.
* If the first subject in the dose trial group does not experience DLT after 28 days, - the remaining two subjects in that dose trial group will be enrolled.
Once all subjects in the dose trial group have completed the infusion and have been observed for 28 days, the clinical data of all subjects will be submitted to the SRC. After a comprehensive evaluation, the SRC will provide recommendations for dose escalation.
Bone marrow mesenchymal stem cells (low dose)
Administered intravenously. For phase I: single infusion, 1.0×10\^6 cells/kg. For phase II: 1.0×10\^6 cells /kg once a week for a total of 4 times.
Phase 1: Medium Dose Group
The trial group with a low dose (2.0×10\^6 cells/kg) will first enroll one subject, who will be infused with single dose CG-BM1 and then observed for at least 28 days. The clinical data of the first subject will be reviewed by the SRC.
* If the first subject in the low-dose trial group experiences DLT, enrollment will be suspended. After discussion, recommendations will be made. If the trial is to continue, two additional subjects will be enrolled for observation. If no DLT occurs, the dose trial group will need to enroll three more subjects.
* If the first subject in the dose trial group does not experience DLT after 28 days, - the remaining two subjects in that dose trial group will be enrolled.
Once all subjects in the dose trial group have completed the infusion and have been observed for 28 days, the clinical data of all subjects will be submitted to the SRC. After a comprehensive evaluation, the SRC will provide recommendations for dose escalation.
Bone marrow mesenchymal stem cells (medium dose)
Administered intravenously. For phase I: single infusion, 2.0×10\^6 cells /kg. For phase II: 2.0×10\^6 cells /kg once a week for a total of 4 times.
Phase 1: High Dose Group
The trial group with a low dose (4.0×10\^6 cells/kg) will first enroll one subject, who will be infused with single dose CG-BM1 and then observed for at least 28 days. The clinical data of the first subject will be reviewed by the SRC.
* If the first subject in the low-dose trial group experiences DLT, enrollment will be suspended. After discussion, recommendations will be made. If the trial is to continue, two additional subjects will be enrolled for observation. If no DLT occurs, the dose trial group will need to enroll three more subjects.
* If the first subject in the dose trial group does not experience DLT after 28 days, - the remaining two subjects in that dose trial group will be enrolled.
Once all subjects in the dose trial group have completed the infusion and have been observed for 28 days, the clinical data of all subjects will be submitted to the SRC. After a comprehensive evaluation, the SRC will provide recommendations for dose escalation.
Bone marrow mesenchymal stem cells (high dose)
Administered intravenously. For phase I: single infusion, 4×10\^6 cells /kg.
Interventions
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Bone marrow mesenchymal stem cells (low dose)
Administered intravenously. For phase I: single infusion, 1.0×10\^6 cells/kg. For phase II: 1.0×10\^6 cells /kg once a week for a total of 4 times.
Solvent of CG-BM1
Administered intravenously, once a week for a total of 4 doses.
Bone marrow mesenchymal stem cells (medium dose)
Administered intravenously. For phase I: single infusion, 2.0×10\^6 cells /kg. For phase II: 2.0×10\^6 cells /kg once a week for a total of 4 times.
Bone marrow mesenchymal stem cells (high dose)
Administered intravenously. For phase I: single infusion, 4×10\^6 cells /kg.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Age ≥18 years old, male or female.
3. Diagnostic criteria in accordance with the Guidelines for Diagnosis and Treatment of Liver Failure (2018 edition) issued by the Liver Failure and Artificial Liver Group of the Infectious Diseases Branch of the Chinese Medical Association and the Liver Disease Branch of the Chinese Medical Association Diagnostic criteria, specific indicators include 1) Suffering from the basis of chronic liver disease; 2) Serum TBIL 171 μ mol/l or mean daily rise ≥17.1 μmol/L; 3) Meeting any of the following three: i. Having a bleeding tendency; ii. Comorbid hepatic encephalopathy; iii. Comorbid hepatorenal syndrome.
4. The cause of liver failure is unlimited.
5. Model for End Stage Liver Disease (MELD) score under 30.
6. No conception (or conception of sexual partner) during the study period (from signing of informed consent to the last visit) and within 6 months after the last cell infusion; and childbearing, or breastfeeding potential, including:
* Female subject with persistent spontaneous menopause \>12 months or who have undergone sterilization (e.g., tubal ligation or bilateral oophorectomy or hysterectomy).
* Non-menopausal female subject with a negative serum pregnancy test within 7 days prior to the first cellular infusion. Sign an informed consent and willingness to use one of the following effective methods of contraception, including intrauterine device (IUD), tubal ligation, double barrier method (condom, vaginal diaphragm, spermicide) and spermicide for the male partner, but does not include oral contraceptives, for a period of 6 months after the last cellular infusion.
* Male subjects who are willing to use one or more effective methods of contraception, including vasectomy, double-barrier methods, use of the pill by the female partner, intrauterine devices or tubal ligation from the time of the first infusion until 6 months after the last infusion.
* Male or non-menopausal female subjects who do not have, or are willing to not have sexual intercourse during the study and for 6 months after the last cell infusion.
1. Voluntarily participate in the clinical study. The patient or legal guardian fully understands and is informed about the study and signs an informed consent form. Willing to follow and be able to complete all trial procedures.
2. Age ≥18 years old, male or female.
3. Diagnostic criteria in accordance with the Guidelines for Diagnosis and Treatment of Liver Failure (2018 edition) issued by the Liver Failure and Artificial Liver Group of the Infectious Diseases Branch of the Chinese Medical Association and the Liver Disease Branch of the Chinese Medical Association Diagnostic criteria, specific indicators include 1) Suffering from the basis of chronic liver disease; 2) Serum TBIL 171 μ mol/l or mean daily rise ≥17.1 μmol/L; 3) Meeting any of the following three: i. Having a bleeding tendency; ii. Comorbid hepatic encephalopathy; iii. Comorbid hepatorenal syndrome.
4. The cause of liver failure is Hepatitis B.
5. Model for End Stage Liver Disease (MELD) score under 30.
6. No conception (or conception of sexual partner) during the study period (from signing of informed consent to the last visit) and within 6 months after the last cell infusion; and childbearing, or breastfeeding potential, including:
* Female subject with persistent spontaneous menopause \>12 months or who have undergone sterilization (e.g., tubal ligation or bilateral oophorectomy or hysterectomy).
* Non-menopausal female subject with a negative serum pregnancy test within 7 days prior to the first cellular infusion. Sign an informed consent and willingness to use one of the following effective methods of contraception, including intrauterine device (IUD), tubal ligation, double barrier method (condom, vaginal diaphragm, spermicide) and spermicide for the male partner, but does not include oral contraceptives, for a period of 6 months after the last cellular infusion.
* Male subjects who are willing to use one or more effective methods of contraception, including vasectomy, double-barrier methods, use of the pill by the female partner, intrauterine devices or tubal ligation from the time of the first infusion until 6 months after the last infusion.
* Male or non-menopausal female subjects who do not have, or are willing to not have sexual intercourse during the study and for 6 months after the last cell infusion.
Exclusion Criteria
2. Patients with severe infections such as septic shock.
3. Patients with gastrointestinal bleeding at the time of screening.
4. Hepatic encephalopathy grade 4.
5. Concurrent failure of 3 or more organs (liver failure defined as TBiL ≥12 mg/dl, renal failure defined as creatinine ≥2.0 mg/dl, coagulation failure defined as INR ≥2.5, cerebral failure defined as hepatic encephalopathy grades 3-4, circulatory failure defined by use of vasoactive drugs, and respiratory failure was defined as PaO2 /FiO2 ≤200 or SpO2 /FiO2 ≤214 or mechanical ventilation)
6. Pregnancy or breastfeeding.
7. Previous history of malignant tumors.
8. Imaging suggestive of intrahepatic nodular space-occupying lesions.
9. A history of immunodeficiency, including HIV-positive, or other acquired or congenital immunodeficiency diseases.
10. Patients with previous liver transplantation.
11. Deep vein thrombosis at screening or history of pulmonary embolism within 3 months prior to screening.
12. Patients with pulmonary hypertension.
13. History of myocardial infarction within 6 months.
14. Previous stem cell therapy.
15. Participation in another interventional clinical trial within 3 months or 5 half-lives (for experimental drug interventions only, whichever is longer) prior to infusion.
16. Any other factors that, in the judgment of the investigator, make the subject inappropriate for participation in this trial.
Phase II:
1. Be allergic to known components of the drug (the main component of the product is bone marrow mesenchymal stem cells, excipients include dimethyl sulfoxide, human albumin) or other history of severe allergy.
2. Patients with severe infections such as septic shock.
3. Patients with gastrointestinal bleeding at the time of screening.
4. Hepatic encephalopathy grade 4.
5. Concurrent failure of 3 or more organs (liver failure defined as TBiL ≥12 mg/dl, renal failure defined as creatinine ≥2.0 mg/dl, coagulation failure defined as INR ≥2.5, cerebral failure defined as hepatic encephalopathy grades 3-4, circulatory failure defined by use of vasoactive drugs, and respiratory failure was defined as PaO2 /FiO2 ≤200 or SpO2 /FiO2 ≤214 or mechanical ventilation)
6. Pregnancy or breastfeeding.
7. Previous history of malignant tumors.
8. Imaging suggestive of intrahepatic solid nodal space-occupying lesions and which the investigator determines may compromise subject safety.
9. Received artificial liver therapy within 7 days prior to first dose.
10. A history of immunodeficiency, including HIV-positive, or other acquired or congenital immunodeficiency diseases.
11. Patients with previous liver transplantation.
12. Deep vein thrombosis at screening or history of pulmonary embolism within 3 months prior to screening.
13. Patients with pulmonary hypertension.
14. History of myocardial infarction within 6 months.
15. Previous stem cell therapy.
16. Participation in another interventional clinical trial within 3 months or 5 half-lives (for experimental drug interventions only, whichever is longer) prior to infusion.
17. Any other factors that, in the judgment of the investigator, make the subject inappropriate for participation in this trial.
18 Years
ALL
No
Sponsors
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Guangzhou Cellgenes Biotechnology Co.,Ltd
UNKNOWN
Sun Yat-sen University
OTHER
Responsible Party
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Lin Bingliang
professor
Locations
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Third Affliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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Bingliang Lin, MD
Role: primary
References
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Klopp AH, Gupta A, Spaeth E, Andreeff M, Marini F 3rd. Concise review: Dissecting a discrepancy in the literature: do mesenchymal stem cells support or suppress tumor growth? Stem Cells. 2011 Jan;29(1):11-9. doi: 10.1002/stem.559.
Kaipe H, Carlson LM, Erkers T, Nava S, Mollden P, Gustafsson B, Qian H, Li X, Hashimoto T, Sadeghi B, Alheim M, Ringden O. Immunogenicity of decidual stromal cells in an epidermolysis bullosa patient and in allogeneic hematopoietic stem cell transplantation patients. Stem Cells Dev. 2015 Jun 15;24(12):1471-82. doi: 10.1089/scd.2014.0568. Epub 2015 Mar 13.
Hare JM, Fishman JE, Gerstenblith G, DiFede Velazquez DL, Zambrano JP, Suncion VY, Tracy M, Ghersin E, Johnston PV, Brinker JA, Breton E, Davis-Sproul J, Schulman IH, Byrnes J, Mendizabal AM, Lowery MH, Rouy D, Altman P, Wong Po Foo C, Ruiz P, Amador A, Da Silva J, McNiece IK, Heldman AW, George R, Lardo A. Comparison of allogeneic vs autologous bone marrow-derived mesenchymal stem cells delivered by transendocardial injection in patients with ischemic cardiomyopathy: the POSEIDON randomized trial. JAMA. 2012 Dec 12;308(22):2369-79. doi: 10.1001/jama.2012.25321.
Poncelet AJ, Vercruysse J, Saliez A, Gianello P. Although pig allogeneic mesenchymal stem cells are not immunogenic in vitro, intracardiac injection elicits an immune response in vivo. Transplantation. 2007 Mar 27;83(6):783-90. doi: 10.1097/01.tp.0000258649.23081.a3.
Ra JC, Shin IS, Kim SH, Kang SK, Kang BC, Lee HY, Kim YJ, Jo JY, Yoon EJ, Choi HJ, Kwon E. Safety of intravenous infusion of human adipose tissue-derived mesenchymal stem cells in animals and humans. Stem Cells Dev. 2011 Aug;20(8):1297-308. doi: 10.1089/scd.2010.0466. Epub 2011 Mar 17.
Zhang K, Sun H, Cao H, Jia Y, Shu X, Cao H, Zhang Y, Yang X. The impact of recipient age on the effects of umbilical cord mesenchymal stem cells on HBV-related acute-on-chronic liver failure and liver cirrhosis. Stem Cell Res Ther. 2021 Aug 20;12(1):466. doi: 10.1186/s13287-021-02544-x.
Xu WX, He HL, Pan SW, Chen YL, Zhang ML, Zhu S, Gao ZL, Peng L, Li JG. Combination Treatments of Plasma Exchange and Umbilical Cord-Derived Mesenchymal Stem Cell Transplantation for Patients with Hepatitis B Virus-Related Acute-on-Chronic Liver Failure: A Clinical Trial in China. Stem Cells Int. 2019 Feb 4;2019:4130757. doi: 10.1155/2019/4130757. eCollection 2019.
Li YH, Xu Y, Wu HM, Yang J, Yang LH, Yue-Meng W. Umbilical Cord-Derived Mesenchymal Stem Cell Transplantation in Hepatitis B Virus Related Acute-on-Chronic Liver Failure Treated with Plasma Exchange and Entecavir: a 24-Month Prospective Study. Stem Cell Rev Rep. 2016 Dec;12(6):645-653. doi: 10.1007/s12015-016-9683-3.
Shi M, Zhang Z, Xu R, Lin H, Fu J, Zou Z, Zhang A, Shi J, Chen L, Lv S, He W, Geng H, Jin L, Liu Z, Wang FS. Human mesenchymal stem cell transfusion is safe and improves liver function in acute-on-chronic liver failure patients. Stem Cells Transl Med. 2012 Oct;1(10):725-31. doi: 10.5966/sctm.2012-0034. Epub 2012 Oct 11.
Schacher FC, Martins Pezzi da Silva A, Silla LMDR, Alvares-da-Silva MR. Bone Marrow Mesenchymal Stem Cells in Acute-on-Chronic Liver Failure Grades 2 and 3: A Phase I-II Randomized Clinical Trial. Can J Gastroenterol Hepatol. 2021 Aug 4;2021:3662776. doi: 10.1155/2021/3662776. eCollection 2021.
Peng L, Xie DY, Lin BL, Liu J, Zhu HP, Xie C, Zheng YB, Gao ZL. Autologous bone marrow mesenchymal stem cell transplantation in liver failure patients caused by hepatitis B: short-term and long-term outcomes. Hepatology. 2011 Sep 2;54(3):820-8. doi: 10.1002/hep.24434. Epub 2011 Jul 14.
Lin BL, Chen JF, Qiu WH, Wang KW, Xie DY, Chen XY, Liu QL, Peng L, Li JG, Mei YY, Weng WZ, Peng YW, Cao HJ, Xie JQ, Xie SB, Xiang AP, Gao ZL. Allogeneic bone marrow-derived mesenchymal stromal cells for hepatitis B virus-related acute-on-chronic liver failure: A randomized controlled trial. Hepatology. 2017 Jul;66(1):209-219. doi: 10.1002/hep.29189. Epub 2017 May 27.
Zheng J, Chen L, Lu T, Zhang Y, Sui X, Li Y, Huang X, He L, Cai J, Zhou C, Liang J, Chen G, Yao J, Yang Y. MSCs ameliorate hepatocellular apoptosis mediated by PINK1-dependent mitophagy in liver ischemia/reperfusion injury through AMPKalpha activation. Cell Death Dis. 2020 Apr 20;11(4):256. doi: 10.1038/s41419-020-2424-1.
Zhao S, Liu Y, Pu Z. Bone marrow mesenchymal stem cell-derived exosomes attenuate D-GaIN/LPS-induced hepatocyte apoptosis by activating autophagy in vitro. Drug Des Devel Ther. 2019 Aug 19;13:2887-2897. doi: 10.2147/DDDT.S220190. eCollection 2019.
Naji A, Eitoku M, Favier B, Deschaseaux F, Rouas-Freiss N, Suganuma N. Biological functions of mesenchymal stem cells and clinical implications. Cell Mol Life Sci. 2019 Sep;76(17):3323-3348. doi: 10.1007/s00018-019-03125-1. Epub 2019 May 4.
Le Blanc K, Tammik C, Rosendahl K, Zetterberg E, Ringden O. HLA expression and immunologic properties of differentiated and undifferentiated mesenchymal stem cells. Exp Hematol. 2003 Oct;31(10):890-6. doi: 10.1016/s0301-472x(03)00110-3.
Horwitz EM, Le Blanc K, Dominici M, Mueller I, Slaper-Cortenbach I, Marini FC, Deans RJ, Krause DS, Keating A; International Society for Cellular Therapy. Clarification of the nomenclature for MSC: The International Society for Cellular Therapy position statement. Cytotherapy. 2005;7(5):393-5. doi: 10.1080/14653240500319234.
Li J, Liang X, Jiang J, Yang L, Xin J, Shi D, Lu Y, Li J, Ren K, Hassan HM, Zhang J, Chen P, Yao H, Li J, Wu T, Jin L, Ye P, Li T, Zhang H, Sun S, Guo B, Zhou X, Cai Q, Chen J, Xu X, Huang J, Hao S, He J, Xin S, Wang D, Trebicka J, Chen X, Li J; Chinese Group on the Study of Severe Hepatitis B (COSSH). PBMC transcriptomics identifies immune-metabolism disorder during the development of HBV-ACLF. Gut. 2022 Jan;71(1):163-175. doi: 10.1136/gutjnl-2020-323395. Epub 2021 Jan 11.
Wu T, Li J, Shao L, Xin J, Jiang L, Zhou Q, Shi D, Jiang J, Sun S, Jin L, Ye P, Yang L, Lu Y, Li T, Huang J, Xu X, Chen J, Hao S, Chen Y, Xin S, Gao Z, Duan Z, Han T, Wang Y, Gan J, Feng T, Pan C, Chen Y, Li H, Huang Y, Xie Q, Lin S, Li L, Li J; Chinese Group on the Study of Severe Hepatitis B (COSSH).. Development of diagnostic criteria and a prognostic score for hepatitis B virus-related acute-on-chronic liver failure. Gut. 2018 Dec;67(12):2181-2191. doi: 10.1136/gutjnl-2017-314641. Epub 2017 Sep 19.
Shi Y, Yang Y, Hu Y, Wu W, Yang Q, Zheng M, Zhang S, Xu Z, Wu Y, Yan H, Chen Z. Acute-on-chronic liver failure precipitated by hepatic injury is distinct from that precipitated by extrahepatic insults. Hepatology. 2015 Jul;62(1):232-42. doi: 10.1002/hep.27795. Epub 2015 Apr 25.
Lin B, Pan CQ, Xie D, Xie J, Xie S, Zhang X, Wu B, Lin C, Gao Z. Entecavir improves the outcome of acute-on-chronic liver failure due to the acute exacerbation of chronic hepatitis B. Hepatol Int. 2013 Jun;7(2):460-7. doi: 10.1007/s12072-012-9415-y. Epub 2013 Feb 11.
Mezzano G, Juanola A, Cardenas A, Mezey E, Hamilton JP, Pose E, Graupera I, Gines P, Sola E, Hernaez R. Global burden of disease: acute-on-chronic liver failure, a systematic review and meta-analysis. Gut. 2022 Jan;71(1):148-155. doi: 10.1136/gutjnl-2020-322161. Epub 2021 Jan 12.
Sarin SK, Choudhury A, Sharma MK, Maiwall R, Al Mahtab M, Rahman S, Saigal S, Saraf N, Soin AS, Devarbhavi H, Kim DJ, Dhiman RK, Duseja A, Taneja S, Eapen CE, Goel A, Ning Q, Chen T, Ma K, Duan Z, Yu C, Treeprasertsuk S, Hamid SS, Butt AS, Jafri W, Shukla A, Saraswat V, Tan SS, Sood A, Midha V, Goyal O, Ghazinyan H, Arora A, Hu J, Sahu M, Rao PN, Lee GH, Lim SG, Lesmana LA, Lesmana CR, Shah S, Prasad VGM, Payawal DA, Abbas Z, Dokmeci AK, Sollano JD, Carpio G, Shresta A, Lau GK, Fazal Karim M, Shiha G, Gani R, Kalista KF, Yuen MF, Alam S, Khanna R, Sood V, Lal BB, Pamecha V, Jindal A, Rajan V, Arora V, Yokosuka O, Niriella MA, Li H, Qi X, Tanaka A, Mochida S, Chaudhuri DR, Gane E, Win KM, Chen WT, Rela M, Kapoor D, Rastogi A, Kale P, Rastogi A, Sharma CB, Bajpai M, Singh V, Premkumar M, Maharashi S, Olithselvan A, Philips CA, Srivastava A, Yachha SK, Wani ZA, Thapa BR, Saraya A, Shalimar, Kumar A, Wadhawan M, Gupta S, Madan K, Sakhuja P, Vij V, Sharma BC, Garg H, Garg V, Kalal C, Anand L, Vyas T, Mathur RP, Kumar G, Jain P, Pasupuleti SSR, Chawla YK, Chowdhury A, Alam S, Song DS, Yang JM, Yoon EL; APASL ACLF Research Consortium (AARC) for APASL ACLF working Party.. Acute-on-chronic liver failure: consensus recommendations of the Asian Pacific association for the study of the liver (APASL): an update. Hepatol Int. 2019 Jul;13(4):353-390. doi: 10.1007/s12072-019-09946-3. Epub 2019 Jun 6.
Other Identifiers
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CGBM1-ACLF
Identifier Type: -
Identifier Source: org_study_id