Acute-On-Chronic Liver FailurePhase 1/2NCT06740149

Efficacy and Safety of BMSCs (CG-BM1) for ACLF Patients

A Phase 1/2 study testing Bone marrow mesenchymal stem cells (low dose), Solvent of CG-BM1 and Bone marrow mesenchymal stem cells (medium dose) in people with Acute-On-Chronic Liver Failure, run by GuangZhou Cellgenes Biotechnology Co., Ltd. at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

The goal of this clinical trial is to learn if CG-BM1 Allogeneic Human Bone Marrow Mesenchymal Stem Cell Injection (hereinafter referred to as CG-BM1) can treat acute-on-chronic liver failure (ACLF) patients. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Acute-On-Chronic Liver Failure
What is being tested?: Bone marrow mesenchymal stem cells (low dose), Solvent of CG-BM1 and Bone marrow mesenchymal stem cells (medium dose)
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 100 participants
Where: 1 siteChina
Study dates: 1 Mar 2023to 31 May 2026
Phase: Phase 1/2
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.
Age ≥18 years old, male or female.
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.
The cause of liver failure is unlimited.
Model for End Stage Liver Disease (MELD) score under 30.
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:

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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.
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.
Age ≥18 years old, male or female.
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.
The cause of liver failure is Hepatitis B.
Model for End Stage Liver Disease (MELD) score under 30.
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.

Who cannot join

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.
Patients with severe infections such as septic shock.
Patients with gastrointestinal bleeding at the time of screening.
Hepatic encephalopathy grade 4.
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)
Pregnancy or breastfeeding.

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Previous history of malignant tumors.
Imaging suggestive of intrahepatic nodular space-occupying lesions.
A history of immunodeficiency, including HIV-positive, or other acquired or congenital immunodeficiency diseases.
Patients with previous liver transplantation.
Deep vein thrombosis at screening or history of pulmonary embolism within 3 months prior to screening.
Patients with pulmonary hypertension.
History of myocardial infarction within 6 months.
Previous stem cell therapy.
Participation in another interventional clinical trial within 3 months or 5 half-lives (for experimental drug interventions only, whichever is longer) prior to infusion.
Any other factors that, in the judgment of the investigator, make the subject inappropriate for participation in this trial.
Phase II:
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.
Patients with severe infections such as septic shock.
Patients with gastrointestinal bleeding at the time of screening.
Hepatic encephalopathy grade 4.
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)
Pregnancy or breastfeeding.
Previous history of malignant tumors.
Imaging suggestive of intrahepatic solid nodal space-occupying lesions and which the investigator determines may compromise subject safety.
Received artificial liver therapy within 7 days prior to first dose.
A history of immunodeficiency, including HIV-positive, or other acquired or congenital immunodeficiency diseases.
Patients with previous liver transplantation.
Deep vein thrombosis at screening or history of pulmonary embolism within 3 months prior to screening.
Patients with pulmonary hypertension.
History of myocardial infarction within 6 months.
Previous stem cell therapy.
Participation in another interventional clinical trial within 3 months or 5 half-lives (for experimental drug interventions only, whichever is longer) prior to infusion.
Any other factors that, in the judgment of the investigator, make the subject inappropriate for participation in this trial.

Trial locations and contacts

1 site in 1 country.

China1 site

Third Affliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510630

Other trials in China

About this study

Official title: Efficacy and Safety of Allogeneic Human Bone Marrow Mesenchymal Stem Cells for the Treatment of Patients With Acute-on-chronic Liver Failure

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.

Read the detailed description

CG-BM1 is a bone marrow mesenchymal stem cell product independently developed by Guangzhou Cellgenes Biotechnology Co., Ltd. The active ingredient of CG-BM1 is human bone marrow mesenchymal stem cell, which is derived from bone marrow donated by healthy adults and prepared into stem cell injection under aseptic conditions. CG-BM1 is the first bone marrow mesenchymal stem cell (BMSC) therapeutic drug for the treatment of ACLF in China. Preclinical data showed that CG-BM1 has the ability to immunomodulate, inhibit the secretion of pro-inflammatory factors by immune cells, and up-regulate the level of anti-inflammatory factors, which can significantly improve the liver function, reduce the inflammatory response, and reverse hepatic fibrosis in ACLF animal models, and the results of the study suggest that it is safe and effective, supporting its further clinical development. The purpose of this study was to evaluate the safety and tolerability of CG-BM1 for the treatment of patients with ACLF, as well as to evaluate the preliminary efficacy of CG-BM1 for the treatment of patients with ACLF.

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: Acute-On-Chronic Liver Failure
Being tested: Bone marrow mesenchymal stem cells (low dose), Solvent of CG-BM1, Bone marrow mesenchymal stem cells (medium dose), Bone marrow mesenchymal stem cells (high dose)
Keywords: bone marrow mesenchymal stem cells, acute-on-chronic liver failure
Medical subject headings: Acute-On-Chronic Liver Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Bone marrow mesenchymal stem cells (low dose)Drug
Also called CG-BM1
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-BM1Drug
Administered intravenously, once a week for a total of 4 doses.
Bone marrow mesenchymal stem cells (medium dose)Drug
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)Drug
Administered intravenously. For phase I: single infusion, 4×10^6 cells /kg.

Study groups in NCT06740149
Study group	Role	What they receive
Phase 2: Placebo Control	Placebo comparator	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. Receives: Drug: Solvent of CG-BM1
Phase 2: Low Dose Group	Experimental	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. Receives: Drug: Bone marrow mesenchymal stem cells (low dose)
Phase 2: Medium Dose Group	Experimental	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. Receives: Drug: Bone marrow mesenchymal stem cells (medium dose)
Phase 1: Low Dose Group	Experimental	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. Receives: Drug: Bone marrow mesenchymal stem cells (low dose)
Phase 1: Medium Dose Group	Experimental	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. Receives: Drug: Bone marrow mesenchymal stem cells (medium dose)
Phase 1: High Dose Group	Experimental	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. Receives: Drug: Bone marrow mesenchymal stem cells (high dose)

What is being measured

The primary outcome is the main question the study is designed to answer.

Phase I: Incidence of CG-BM1-related dose-limiting toxicity (DLT) events
Incidence of CG-BM1-related DLT events.
Measured: From first dose to 180 days after the first dose.
Phase I: Adverse event related to CG-BM1 treatment
Any adverse event related to CG-BM1 treatment that occurred during the study period.
Measured: From first dose to 180 days after the first dose.
Phase II: Liver transplant-free survival
90-day liver transplant-free survival.
Measured: 90 day after the first dose.

Secondary outcomes (34)

Phase I: Liver transplant-free survival
28-day, 90-day, and 180-day liver transplant-free survival.
Measured: 28 day, 90 day, and 180 days after the first dose.
Phase I: Changes of aspartate aminotransferase (AST)
Amount of increase or decrease in serum AST.
Measured: Pre-treatment, 3 days, 7 days, 14 days, 21 days, 28 days, 90 days after the first dose.
Phase I: Changes of alanine aminotransferase (ALT)
Amount of increase or decrease in serum ALT.
Measured: Pre-treatment, 3 days, 7 days, 14 days, 21 days, 28 days, 90 days after the first dose.
Phase I: Changes of albumin
Amount of increase or decrease in serum albumin.
Measured: Pre-treatment, 3 days, 7 days, 14 days, 21 days, 28 days, 90 days after the first dose.
Phase I: Changes of alkaline phosphatase (ALP)
Amount of increase or decrease in serum ALP.
Measured: Pre-treatment, 3 days, 7 days, 14 days, 21 days, 28 days, 90 days after the first dose.
Phase I: Changes of γ-glutamyl transpeptidase (GGT)
Amount of increase or decrease in serum GGT.
Measured: Pre-treatment, 3 days, 7 days, 14 days, 21 days, 28 days, 90 days after the first dose.
Phase I: Changes of total bilirubin (TBil)
Amount of increase or decrease in serum TBil.
Measured: Pre-treatment, 3 days, 7 days, 14 days, 21 days, 28 days, 90 days after the first dose.
Phase I: Changes of international normalized ratio (INR)
Amount of increase or decrease in INR.
Measured: Pre-treatment, 3 days, 7 days, 14 days, 21 days, 28 days, 90 days after the first dose.
Phase I: Changes in liver stiffness measurement (LSM) values
Changes in LSM values measured by transient elastography (TE).
Measured: Pre-treatment, 14 days, 28 days, 60 days, 90 days after the first dose.
Phase I: Changes of 15-minute retention rate obtained by indocyanine green (ICG) retention test
Changes of 15-minute retention rate obtained by indocyanine green (ICG) retention test. Inject indocyanine green (ICG) rapidly into a peripheral vein on one side of the patient at a dose of 0.5mg/kg body weight, and start timing immediately after the injection. After 15 minutes, draw 2ml of blood from the opposite side peripheral vein, separate the serum, and measure the concentration of indocyanine green using a spectrophotometer. Calculate the indocyanine green retention rate at 15 minutes using the following formula: ICG Retention Rate (%) = (C15 mg% ÷ 1 mg%) × 100%.
Measured: Pre-treatment, 7 days, 14 days, 28 days, 60 days, 90 days after the first dose.
Phase I: Complication rate
Complication rate within 180 days.
Measured: 180 days after the first dose.
Phase I: Changes in chronic liver failure consortium organ failure score (CLIF-C OFs)
Changes in CLIF-C OFs. Each organ system is scored on a scale to generate the overall CLIF-C OF score, ranging from 0 to 18. The higher the CLIF C OF score, the poorer the prognosis for the patient, which means a higher short-term mortality rate.
Measured: Pre-treatment, 3 days, 7 days, 14 days, 28 days, 60 days, 90 days after the first dose.
Phase I: Changes in Model for end-stage liver disease (MELD) score
MELDScore = 10 * ((0.957 * ln(Creatinine)) + (0.378 * ln(Bilirubin)) + (1.12 * ln(INR))) + 6.43. An increase in the MELD score indicates worse liver function, poorer prognosis, and a higher urgency for liver transplantation.
Measured: Pre-treatment, 3 days, 7 days, 14 days, 28 days, 60 days, 90 days after the first dose.
Phase I: Anti-human histocompatibility antigen antibody (HLA-Ab) positivity rate
Serum HLA-Ab positivity rate.
Measured: Pre-treatment, 28 days, 60 days after the first dose.
Phase I: Serum Interleukin-6 (IL-6) levels
Serum IL-6 levels.
Measured: Pre-treatment, 3 days, 7 days, 14 days, 21 days, 28 days after the first dose.
Phase I: Serum tumor necrosis factor-α (TNF-α) levels
Serum TNF-α levels.
Measured: Pre-treatment, 3 days, 7 days, 14 days, 21 days, 28 days after the first dose.
Phase II: Adverse event related to CG-BM1 treatment
Any adverse event related to CG-BM1 treatment that occurred during the study period.
Measured: From first dose to 180 days after the first dose.
Phase II: Liver transplant-free survival
28-day, 180-day liver transplant-free survival.
Measured: 28 days, 180 days after the first dose.
Phase II: Changes in Model for end-stage liver disease (MELD) score
MELDScore = 10 * ((0.957 * ln(Creatinine)) + (0.378 * ln(Bilirubin)) + (1.12 * ln(INR))) + 6.43. An increase in the MELD score indicates worse liver function, poorer prognosis, and a higher urgency for liver transplantation.
Measured: Pre-treatment, 28 days, 60 days, 90 days, 180 days after the first dose.
Phase II: Changes in chronic liver failure consortium organ failure score (CLIF-C OFs)
Changes in CLIF-C OFs. Each organ system is scored on a scale to generate the overall CLIF-C OF score, ranging from 0 to 18. The higher the CLIF-C OF score, the poorer the prognosis for the patient, which means a higher short-term mortality rate.
Measured: Pre-treatment, 28 days, 60 days, 90 days, 180 days after the first dose.
Phase II: Complication rate
Complication rate within 180 days. Including: cerebral edema, hepatic encephalopathy, infection, hyponatremia, refractory ascites, acute kidney injury, hepatorenal syndrome, hemorrhage, hepatopulmonary syndrome.
Measured: 180 days after the first dose.
Phase II: Changes of aspartate aminotransferase (AST)
Amount of increase or decrease in serum AST.
Measured: Pre-treatment, 28 days, 60 days, 90 days, 180 days after the first dose.
Phase II: Changes of alanine aminotransferase (ALT)
Amount of increase or decrease in serum ALT.
Measured: Pre-treatment, 28 days, 60 days, 90 days, 180 days after the first dose.
Phase II: Changes of albumin
Amount of increase or decrease in serum albumin.
Measured: Pre-treatment, 28 days, 60 days, 90 days, 180 days after the first dose.
Phase II: Changes of alkaline phosphatase (ALP)
Amount of increase or decrease in serum ALP.
Measured: Pre-treatment, 28 days, 60 days, 90 days, 180 days after the first dose.
Phase II: Changes of γ-glutamyl transpeptidase (GGT)
Amount of increase or decrease in serum GGT.
Measured: Pre-treatment, 28 days, 60 days, 90 days, 180 days after the first dose.
Phase II: Changes of total bilirubin (TBil)
Amount of increase or decrease in serum TBil.
Measured: Pre-treatment, 28 days, 60 days, 90 days, 180 days after the first dose.
Phase II: Changes of international normalized ratio (INR)
Amount of increase or decrease in INR.
Measured: Pre-treatment, 28 days, 60 days, 90 days, 180 days after the first dose.
Phase II: Changes in liver stiffness measurement (LSM) values
Changes in LSM values measured by transient elastography (TE).
Measured: Pre-treatment, 28 days, 60 days, 90 days, 180 days after the first dose.
Phase II: Changes of 15-minute retention rate obtained by indocyanine green (ICG) retention test
Changes of 15-minute retention rate obtained by indocyanine green (ICG) retention test. Inject indocyanine green (ICG) rapidly into a peripheral vein on one side of the patient at a dose of 0.5mg/kg body weight, and start timing immediately after the injection. After 15 minutes, draw 2ml of blood from the opposite side peripheral vein, separate the serum, and measure the concentration of indocyanine green using a spectrophotometer. Calculate the indocyanine green retention rate at 15 minutes using the following formula: ICG Retention Rate (%) = (C15 mg% ÷ 1 mg%) × 100%.
Measured: Pre-treatment, 28 days, 60 days, 90 days, 180 days after the first dose.
Phase II: Anti-human histocompatibility antigen antibody (HLA-Ab) positivity rate
Serum HLA-Ab positivity rate.
Measured: Pre-treatment, 28 days, 90 days after the first dose.
Phase II: Serum Interleukin-6 (IL-6) levels
Serum IL-6 levels.
Measured: Pre-treatment, 28 days, 60 days, 90 days, 180 days after the first dose.
Phase II: Serum tumor necrosis factor-α (TNF-α) levels
Serum TNF-α levels.
Measured: Pre-treatment, 28 days, 60 days, 90 days, 180 days after the first dose.
Phase II: Serum hepatocyte growth factor (HGF) levels
Serum HGF levels.
Measured: Pre-treatment, 28 days, 60 days, 90 days, 180 days after the first dose.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Mar 202331 May 2026

First posted18 Dec 2024
Study start1 Mar 2023
Primary completion31 Mar 2026
Study completion31 May 2026

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (23)Papers the sponsor has linked to this study.
Other trials for Acute-On-Chronic Liver FailureStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1/2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06740149
Sponsor's protocol ID: CGBM1-ACLF-I01
Status last verified: Oct 2026
First submitted: 11 Dec 2024
Last updated: 21 Oct 2026
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 21280155
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.
PubMed 25658253
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.
PubMed 23117550
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.
PubMed 17414713
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.
PubMed 21303266
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.
PubMed 34416908
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.
PubMed 30863450
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.
PubMed 27687792
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.
PubMed 23197664
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.
PubMed 34395335
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.
PubMed 21608000
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.
PubMed 28370357
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.
PubMed 32312955
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.
PubMed 31695322
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.
PubMed 31055643

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What is the study trying to find out?
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See locations

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All Acute-On-Chronic Liver Failure trials

Study at a glance

From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Efficacy and Safety of Allogeneic Human Bone Marrow Mesenchymal Stem Cells for the Treatment of Patients With Acute-on-chronic Liver Failure
ClinicalTrials.gov ID: NCT06740149
Acronym / sponsor ID: CGBM1-ACLF-I01
Conditions: Acute-On-Chronic Liver Failure
Keywords: bone marrow mesenchymal stem cells, acute-on-chronic liver failure
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 100 participants (actual)
Lead sponsor: GuangZhou Cellgenes Biotechnology Co., Ltd.Industry (pharma, biotech, devices)
Collaborators: West China Hospital, Ruijin Hospital, First Affiliated Hospital Xi'an Jiaotong University, First Affiliated Hospital of Zhejiang University
Study start: 1 Mar 2023 (actual)
Primary completion: 31 Mar 2026 (actual)
Study completion: 31 May 2026 (actual)
First posted: 18 Dec 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 6

Arm	Type	Receives
Phase 2: Placebo Control	Placebo comparator	Drug: Solvent of CG-BM1The 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.
Phase 2: Low Dose Group	Experimental	Drug: Bone marrow mesenchymal stem cells (low dose)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.
Phase 2: Medium Dose Group	Experimental	Drug: Bone marrow mesenchymal stem cells (medium dose)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.
Phase 1: Low Dose Group	Experimental	Drug: Bone marrow mesenchymal stem cells (low dose)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.
Phase 1: Medium Dose Group	Experimental	Drug: Bone marrow mesenchymal stem cells (medium dose)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.
Phase 1: High Dose Group	Experimental	Drug: Bone marrow mesenchymal stem cells (high dose)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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (20 listed)

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.
Age ≥18 years old, male or female.
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.
The cause of liver failure is unlimited.
Model for End Stage Liver Disease (MELD) score under 30.

Key exclusion criteria (34 listed)

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.
Patients with severe infections such as septic shock.
Patients with gastrointestinal bleeding at the time of screening.
Hepatic encephalopathy grade 4.
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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Bone marrow mesenchymal stem cells (low dose)Also: CG-BM1Administered 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.	Drug	Phase 1: Low Dose Group, Phase 2: Low Dose Group
Solvent of CG-BM1Administered intravenously, once a week for a total of 4 doses.	Drug	Phase 2: Placebo Control
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.	Drug	Phase 1: Medium Dose Group, Phase 2: Medium Dose Group
Bone marrow mesenchymal stem cells (high dose)Administered intravenously. For phase I: single infusion, 4×10^6 cells /kg.	Drug	Phase 1: High Dose Group

Primary outcome

Phase I: Incidence of CG-BM1-related dose-limiting toxicity (DLT) events
Time frame: From first dose to 180 days after the first dose.
Incidence of CG-BM1-related DLT events.
Phase I: Adverse event related to CG-BM1 treatment
Time frame: From first dose to 180 days after the first dose.
Any adverse event related to CG-BM1 treatment that occurred during the study period.
Phase II: Liver transplant-free survival
Time frame: 90 day after the first dose.
90-day liver transplant-free survival.

34 secondary outcomes

Phase I: Liver transplant-free survival
Time frame: 28 day, 90 day, and 180 days after the first dose.
Phase I: Changes of aspartate aminotransferase (AST)
Time frame: Pre-treatment, 3 days, 7 days, 14 days, 21 days, 28 days, 90 days after the first dose.
Phase I: Changes of alanine aminotransferase (ALT)
Time frame: Pre-treatment, 3 days, 7 days, 14 days, 21 days, 28 days, 90 days after the first dose.
Phase I: Changes of albumin
Time frame: Pre-treatment, 3 days, 7 days, 14 days, 21 days, 28 days, 90 days after the first dose.
Phase I: Changes of alkaline phosphatase (ALP)
Time frame: Pre-treatment, 3 days, 7 days, 14 days, 21 days, 28 days, 90 days after the first dose.
Phase I: Changes of γ-glutamyl transpeptidase (GGT)
Time frame: Pre-treatment, 3 days, 7 days, 14 days, 21 days, 28 days, 90 days after the first dose.
Phase I: Changes of total bilirubin (TBil)
Time frame: Pre-treatment, 3 days, 7 days, 14 days, 21 days, 28 days, 90 days after the first dose.
Phase I: Changes of international normalized ratio (INR)
Time frame: Pre-treatment, 3 days, 7 days, 14 days, 21 days, 28 days, 90 days after the first dose.
Phase I: Changes in liver stiffness measurement (LSM) values
Time frame: Pre-treatment, 14 days, 28 days, 60 days, 90 days after the first dose.
Phase I: Changes of 15-minute retention rate obtained by indocyanine green (ICG) retention test
Time frame: Pre-treatment, 7 days, 14 days, 28 days, 60 days, 90 days after the first dose.
Phase I: Complication rate
Time frame: 180 days after the first dose.
Phase I: Changes in chronic liver failure consortium organ failure score (CLIF-C OFs)
Time frame: Pre-treatment, 3 days, 7 days, 14 days, 28 days, 60 days, 90 days after the first dose.
Phase I: Changes in Model for end-stage liver disease (MELD) score
Time frame: Pre-treatment, 3 days, 7 days, 14 days, 28 days, 60 days, 90 days after the first dose.
Phase I: Anti-human histocompatibility antigen antibody (HLA-Ab) positivity rate
Time frame: Pre-treatment, 28 days, 60 days after the first dose.
Phase I: Serum Interleukin-6 (IL-6) levels
Time frame: Pre-treatment, 3 days, 7 days, 14 days, 21 days, 28 days after the first dose.
Phase I: Serum tumor necrosis factor-α (TNF-α) levels
Time frame: Pre-treatment, 3 days, 7 days, 14 days, 21 days, 28 days after the first dose.
Phase II: Adverse event related to CG-BM1 treatment
Time frame: From first dose to 180 days after the first dose.
Phase II: Liver transplant-free survival
Time frame: 28 days, 180 days after the first dose.
Phase II: Changes in Model for end-stage liver disease (MELD) score
Time frame: Pre-treatment, 28 days, 60 days, 90 days, 180 days after the first dose.
Phase II: Changes in chronic liver failure consortium organ failure score (CLIF-C OFs)
Time frame: Pre-treatment, 28 days, 60 days, 90 days, 180 days after the first dose.
Phase II: Complication rate
Time frame: 180 days after the first dose.
Phase II: Changes of aspartate aminotransferase (AST)
Time frame: Pre-treatment, 28 days, 60 days, 90 days, 180 days after the first dose.
Phase II: Changes of alanine aminotransferase (ALT)
Time frame: Pre-treatment, 28 days, 60 days, 90 days, 180 days after the first dose.
Phase II: Changes of albumin
Time frame: Pre-treatment, 28 days, 60 days, 90 days, 180 days after the first dose.
Phase II: Changes of alkaline phosphatase (ALP)
Time frame: Pre-treatment, 28 days, 60 days, 90 days, 180 days after the first dose.
Phase II: Changes of γ-glutamyl transpeptidase (GGT)
Time frame: Pre-treatment, 28 days, 60 days, 90 days, 180 days after the first dose.
Phase II: Changes of total bilirubin (TBil)
Time frame: Pre-treatment, 28 days, 60 days, 90 days, 180 days after the first dose.
Phase II: Changes of international normalized ratio (INR)
Time frame: Pre-treatment, 28 days, 60 days, 90 days, 180 days after the first dose.
Phase II: Changes in liver stiffness measurement (LSM) values
Time frame: Pre-treatment, 28 days, 60 days, 90 days, 180 days after the first dose.
Phase II: Changes of 15-minute retention rate obtained by indocyanine green (ICG) retention test
Time frame: Pre-treatment, 28 days, 60 days, 90 days, 180 days after the first dose.
Phase II: Anti-human histocompatibility antigen antibody (HLA-Ab) positivity rate
Time frame: Pre-treatment, 28 days, 90 days after the first dose.
Phase II: Serum Interleukin-6 (IL-6) levels
Time frame: Pre-treatment, 28 days, 60 days, 90 days, 180 days after the first dose.
Phase II: Serum tumor necrosis factor-α (TNF-α) levels
Time frame: Pre-treatment, 28 days, 60 days, 90 days, 180 days after the first dose.
Phase II: Serum hepatocyte growth factor (HGF) levels
Time frame: Pre-treatment, 28 days, 60 days, 90 days, 180 days after the first dose.

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
Background: PubMed 21280155Klopp 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.
Background: PubMed 25658253Kaipe 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.
Background: PubMed 23117550Hare 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.
Background: PubMed 17414713Poncelet 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.
Background: PubMed 21303266Ra 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.
Background: PubMed 34416908Zhang 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.
Background: PubMed 30863450Xu 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.
Background: PubMed 27687792Li 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.
Background: PubMed 23197664Shi 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.
Background: PubMed 34395335Schacher 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.
Background: PubMed 21608000Peng 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.
Background: PubMed 28370357Lin 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 34 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase I: Incidence of CG-BM1-related dose-limiting toxicity (DLT) events (time frame: From first dose to 180 days after the first dose.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06740149, which also lists 23 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.