Cirrhosis Due to Hepatitis BPhase 1/2NCT05507762
Study of Human Umbilical Cord Mesenchymal Stem Cell in Patients With Cirrhosis Due to Hepatitis B (Compensation Stage)
A Phase 1/2 study testing UC-MSCs and Saline solution in people with Cirrhosis Due to Hepatitis B, run by Renmin Hospital of Wuhan University at 1 site in China.
Trial summary
There are about 240 million chronic hepatitis B virus (HBV) infected people in the world, and about 2%-5% of compensated cirrhosis patients progress to decompensated cirrhosis patients every year. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cirrhosis Due to Hepatitis B
- What is being tested?
- UC-MSCs and Saline solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 20 Jul 2021to 20 Aug 2023
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The age is between 18 and 65 years old (including 18 and 65 years old), regardless of gender;
- The hardness of liver was detected by transient elastography, and liver cells were detected by imaging and laboratory examination There were no severe complications such as esophageal varices bleeding, ascites, or hepatic encephalopathy;
- Plasma albumin ≥ 35g / L, total bilirubin < 35μThe activity of prothrombin was more than 60%, The child Pugh score was Grade A;
- Willing to participate in this clinical study, will cooperate with doctors to carry out research, and sign informed consent.
Who cannot join
- Spontaneous peritonitis or other severe infections were found;
- Patients with hepatorenal syndrome;
- Severe hepatic encephalopathy, massive hemorrhage of digestive tract or variceal hemorrhage occurred;
- Combined with serious heart, lung, kidney, blood, endocrine system diseases; There were portal vein thrombosis;
- Patients with positive serum HIV antibody;
- The etiology of liver cirrhosis is not chronic HBV infection (HCV, EBV, CMC, autoimmune liver disease, primary biliary cirrhosis, parasitic, alcoholic, drug-related, genetic metabolic, genetic metabolic diseases), or other factors besides chronic HBV infection;
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- Malignant tumor of liver or other organs;
- Pregnant women, lactating women, or those with recent birth planning;
- Those who have a history of alcoholism and drug abuse and fail to give up effectively;
- Participated in other clinical trials within 3 months before enrollment;
- Participated in stem cell clinical research before;
- Not willing to sign informed consent form;
- Those who have neurological or mental disorders and are unable to cooperate or are unwilling to cooperate;
- Other situations in which the researcher considered that the patient should not participate in the study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Renmin Hospital of Wuhan University
Wuhan, Hubei
YINGAN JIANG, +86 13720389866, jiangya_cn@aliyun.com
About this study
Official title: A Randomized, Double-blind, Controlled Clinical Study of Human Umbilical Cord Mesenchymal Stem Cell in Patients With Cirrhosis Due to Hepatitis B (Compensation Stage)
There are about 240 million chronic hepatitis B virus (HBV) infected people in the world, and about 2%-5% of compensated cirrhosis patients progress to decompensated cirrhosis patients every year. Studies have shown that the 5-year survival rate of decompensated cirrhosis is only 14-35%, and the quality of life and prognosis of patients are poor. Reversing or delaying the process of cirrhosis and reducing the development of compensated cirrhosis to decompensated cirrhosis is one of the effective methods for liver disease treatment. MSCs are mainly derived from bone marrow, but bone marrow mesenchymal stem cells have some shortcomings, such as cumbersome sampling, and the proliferation and differentiation ability of bone marrow mesenchymal stem cells decrease obviously with the age of donors, which is not conducive to cell therapy. Umbilical cord has many advantages, such as wide source, convenient collection, small immune rejection, and small ethical controversy, which makes it a hot spot in stem cell research and has a wider prospect in cell therapy. This clinical study will explore the efficacy and safety of human umbilical cord-derived mesenchymal stem cells in the treatment of hepatitis B virus-infected patients with compensated cirrhosis.
Read the detailed description
There are about 1.7 billion people with different types of chronic liver diseases in the world, of which about 240 million are infected with chronic hepatitis B virus (HBV), and about 15%-40% of chronic hepatitis B can develop into liver cirrhosis and die of liver hardness every year There are hundreds of thousands of patients. There are about 90 million hepatitis B carriers in China, including about 20 million chronic hepatitis B carriers. Every year, about 2%-5% of compensated cirrhosis patients progress to decompensated cirrhosis patients. Studies have shown that the 5-year survival rate of decompensated liver cirrhosis is only 14-35%, and the quality of life and prognosis of patients are poor. From the progression of liver fibrosis to the decompensation of liver cirrhosis, liver failure often occurs. Statistics show that slow increase The 28-day mortality rate of patients with acute liver failure of grade 1, 2 and 3 is as high as 22%, 32% and 77%. The 90-day mortality rate was 41%, 73%, 95%. Orthotopic liver transplantation is the most effective means to treat decompensated liver failure due to liver cirrhosis, However, the shortage of donor liver, immune rejection and high cost have become treatment obstacles. Application of artificial liver support system for blood flow Plasma replacement can remove toxic substances from blood, but it can't supplement albumin and coagulation factors, and it is important to whether reducing the mortality rate is still controversial. Therefore, it reverses or delays the process of liver cirrhosis and reduces the compensatory stage of liver cirrhosis It is an important link in the treatment of liver diseases that the patients develop into decompensated stage The curative effect of medical treatment on hepatitis B cirrhosis (compensatory period) is very limited; Liver transplantation is difficult to popularize in clinical application due to the lack of donors and high cost. Mesenchymal Stem Cells (MSCs) are derived from mesoderm in early development, is a high degree of self-renewal ability, Pluripotent stem cells with high proliferation ability and multidirectional differentiation potential widely exist in bone marrow, fat, umbilical cord blood, umbilical cord, and other tissues. They can be cultured and expanded in vitro, and can differentiate into adipocytes, osteoblasts, cartilage tissues, nerve cells, hepatocytes and so on under the control of specific conditions, which has great application value in cell therapy and tissue engineering. The purpose of this study was to investigate the efficacy and safety of umbilical cord mesenchymal stem cells in the treatment of hepatitis B cirrhosis (compensatory stage). The subjects were randomly divided into two groups: umbilical cord mesenchymal stem cells injected through peripheral vein group and control group, with 10 cases in each group, a total of 20 cases. The subjects were randomly divided into two groups, namely, umbilical cord mesenchymal stem cells injected through peripheral vein group and control group. Patients in the treatment group were treated with stem cells based on conventional medical treatment. The efficacy and adverse reactions of patients were observed in detail within 24 weeks after treatment, and the long-term effect of stem cell therapy was observed after 96 weeks of treatment.
- Conditions
- Cirrhosis Due to Hepatitis B
- Being tested
- UC-MSCs, Saline solution
- Keywords
- cirrhosis, compensatory stage, human umbilical cord derived mesenchymal stem cells, Cirrhosis Due to Hepatitis B
- Medical subject headings
- Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UC-MSCsBiological
Usage: The stem cell preparation in this study is used intravenously in the elbow.
Dose: The dose of stem cell injection in this clinical study is set at 1×10^6/Kg/time per injection Duration: 5 injections per trial group for the entire duration of the course, at 1st treatment, 2-week, 4-week, 16-week, and 24-week respectively
Saline solutionBiological
Usage: The saline solution in this study is used intravenously in the elbow. Dose: The dose of saline solution in this clinical study is set at 250ml/time per injection Duration: 5 injections per person for the entire duration of the course, at 1st treatment, 2-week, 4-week, 16-week, and 24-week respectively
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | MSCs Participants will receive antiviral drug, anti-fibrotic drugs and UC-MSCs Receives: Biological: UC-MSCs |
| Comparator | Placebo comparator | Comparator participants will receive antiviral drug, anti-fibrotic drugs and saline solution Receives: Biological: Saline solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
FibroScan
Parameters of liver stiffness
Measured: Change from Baseline Liver stiffness at week 24
IV-C
Change of Serum hepatic fibrosis indexes
Measured: Change from Baseline at week 24
HA
Change of Serum hepatic fibrosis indexes
Measured: Change from Baseline at week 24
LN
Change of Serum hepatic fibrosis indexes
Measured: Change from Baseline at week 24
PC-III
Change of Serum hepatic fibrosis indexes
Measured: Change from Baseline at week 24
Hepatic histopathologic examination
Status of the liver
Measured: Change from Baseline at week 24
IgG
Change of humoral immunity
Measured: Change from Baseline at week 24
IgA
Change of humoral immunity
Measured: Change from Baseline at week 24
IgM
Change of humoral immunity
Measured: Change from Baseline at week 24
IgE
Change of humoral immunity
Measured: Change from Baseline at week 24
C3
Change of humoral immunity
Measured: Change from Baseline at week 24
C4
Change of humoral immunity
Measured: Change from Baseline at week 24
CD3
Change of cellular immunity
Measured: Change from Baseline at week 24
CD4
Change of cellular immunity
Measured: Change from Baseline at week 24
CD8
Change of cellular immunity
Measured: Change from Baseline at week 24
CD19
Change of cellular immunity
Measured: Change from Baseline at week 24
CD16+56
Change of cellular immunity
Measured: Change from Baseline at week 24
Secondary outcomes (7)
ALB
Change of Liver function
Measured: Change from Baseline at week 24
ALT
Change of Liver function
Measured: Change from Baseline at week 24
AST
Change of Liver function
Measured: Change from Baseline at week 24
TBIL
Change of Liver function
Measured: Change from Baseline at week 24
DBIL
Change of Liver function
Measured: Change from Baseline at week 24
HBV-DNA
Status of HBV infection
Measured: Change from Baseline at week 24
Change of ultrasound examination of liver
Status of the liver
Measured: Change from Baseline at week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2022
- Study start20 Jul 2021
- Primary completion20 Jul 2023 (estimated)
- Study completion20 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cirrhosis Due to Hepatitis BStudies 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Renmin Hospital of Wuhan University
- Sponsor type
- University, hospital or other
- Collaborators
- Vcanbio Cell and Gene Engineering Corp., Ltd., Wuhan Optics Valley Zhongyuan Pharmaceutical Co., Ltd., Hubei, China
- Responsible party
- Principal investigator, Jiang Yingan, Renmin Hospital of Wuhan University
- Investigators
- YINGAN JIANG, Principal investigator, Renmin Hospital of Wuhan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05507762
- Sponsor's protocol ID
- RenminHJiangYingan
- Status last verified
- Aug 2022
- First submitted
- 15 Aug 2022
- Last updated
- 19 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: After approval from the steering committee and the Human Genetic Resources Administration of China, this trial data can be shared with qualifying researchers who submit a proposal with a valuable research question. A contract should besigned.
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Controlled Clinical Study of Human Umbilical Cord Mesenchymal Stem Cell in Patients With Cirrhosis Due to Hepatitis B (Compensation Stage)
- ClinicalTrials.gov ID
- NCT05507762
- Acronym / sponsor ID
- RenminHJiangYingan
- Conditions
- Cirrhosis Due to Hepatitis B
- Keywords
- cirrhosis, compensatory stage, human umbilical cord derived mesenchymal stem cells, Cirrhosis Due to Hepatitis B
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Renmin Hospital of Wuhan UniversityUniversity, hospital or other
- Collaborators
- Vcanbio Cell and Gene Engineering Corp., Ltd., Wuhan Optics Valley Zhongyuan Pharmaceutical Co., Ltd., Hubei, China
- Study start
- 20 Jul 2021 (actual)
- Primary completion
- 20 Jul 2023 (estimated)
- Study completion
- 20 Aug 2023 (estimated)
- First posted
- 19 Aug 2022 (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.
There are about 240 million chronic hepatitis B virus (HBV) infected people in the world, and about 2%-5% of compensated cirrhosis patients progress to decompensated cirrhosis patients every year. Studies have shown that the 5-year survival rate of decompensated cirrhosis is only 14-35%, and the quality of life and prognosis of patients are poor. Reversing or delaying the process of cirrhosis and reducing the development of compensated cirrhosis to decompensated cirrhosis is one of the effective methods for liver disease treatment. MSCs are mainly derived from bone marrow, but bone marrow mesenchymal stem cells have some shortcomings, such as cumbersome sampling, and the proliferation and differentiation ability of bone marrow mesenchymal stem cells decrease obviously with the age of donors, which is not conducive to cell therapy. Umbilical cord has many advantages, such as wide source, convenient collection, small immune rejection, and small ethical controversy, which makes it a hot spot in stem cell research and has a wider prospect in cell therapy. This clinical study will explore the efficacy and safety of human umbilical cord-derived mesenchymal stem cells in the treatment of hepatitis B virus-infected patients with compensated cirrhosis.
Detailed description
There are about 1.7 billion people with different types of chronic liver diseases in the world, of which about 240 million are infected with chronic hepatitis B virus (HBV), and about 15%-40% of chronic hepatitis B can develop into liver cirrhosis and die of liver hardness every year There are hundreds of thousands of patients. There are about 90 million hepatitis B carriers in China, including about 20 million chronic hepatitis B carriers. Every year, about 2%-5% of compensated cirrhosis patients progress to decompensated cirrhosis patients. Studies have shown that the 5-year survival rate of decompensated liver cirrhosis is only 14-35%, and the quality of life and prognosis of patients are poor. From the progression of liver fibrosis to the decompensation of liver cirrhosis, liver failure often occurs. Statistics show that slow increase The 28-day mortality rate of patients with acute liver failure of grade 1, 2 and 3 is as high as 22%, 32% and 77%. The 90-day mortality rate was 41%, 73%, 95%. Orthotopic liver transplantation is the most effective means to treat decompensated liver failure due to liver cirrhosis, However, the shortage of donor liver, immune rejection and high cost have become treatment obstacles. Application of artificial liver support system for blood flow Plasma replacement can remove toxic substances from blood, but it can't supplement albumin and coagulation factors, and it is important to whether reducing the mortality rate is still controversial. Therefore, it reverses or delays the process of liver cirrhosis and reduces the compensatory stage of liver cirrhosis It is an important link in the treatment of liver diseases that the patients develop into decompensated stage The curative effect of medical treatment on hepatitis B cirrhosis (compensatory period) is very limited; Liver transplantation is difficult to popularize in clinical application due to the lack of donors and high cost. Mesenchymal Stem Cells (MSCs) are derived from mesoderm in early development, is a high degree of self-renewal ability, Pluripotent stem cells with high proliferation ability and multidirectional differentiation potential widely exist in bone marrow, fat, umbilical cord blood, umbilical cord, and other tissues. They can be cultured and expanded in vitro, and can differentiate into adipocytes, osteoblasts, cartilage tissues, nerve cells, hepatocytes and so on under the control of specific conditions, which has great application value in cell therapy and tissue engineering. The purpose of this study was to investigate the efficacy and safety of umbilical cord mesenchymal stem cells in the treatment of hepatitis B cirrhosis (compensatory stage). The subjects were randomly divided into two groups: umbilical cord mesenchymal stem cells injected through peripheral vein group and control group, with 10 cases in each group, a total of 20 cases. The subjects were randomly divided into two groups, namely, umbilical cord mesenchymal stem cells injected through peripheral vein group and control group. Patients in the treatment group were treated with stem cells based on conventional medical treatment. The efficacy and adverse reactions of patients were observed in detail within 24 weeks after treatment, and the long-term effect of stem cell therapy was observed after 96 weeks of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Biological: UC-MSCsMSCs Participants will receive antiviral drug, anti-fibrotic drugs and UC-MSCs |
| Comparator | Placebo comparator | Biological: Saline solutionComparator participants will receive antiviral drug, anti-fibrotic drugs and saline solution |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- The age is between 18 and 65 years old (including 18 and 65 years old), regardless of gender;
- The hardness of liver was detected by transient elastography, and liver cells were detected by imaging and laboratory examination There were no severe complications such as esophageal varices bleeding, ascites, or hepatic encephalopathy;
- Plasma albumin ≥ 35g / L, total bilirubin < 35μThe activity of prothrombin was more than 60%, The child Pugh score was Grade A;
- Willing to participate in this clinical study, will cooperate with doctors to carry out research, and sign informed consent.
Key exclusion criteria (14 listed)
- Spontaneous peritonitis or other severe infections were found;
- Patients with hepatorenal syndrome;
- Severe hepatic encephalopathy, massive hemorrhage of digestive tract or variceal hemorrhage occurred;
- Combined with serious heart, lung, kidney, blood, endocrine system diseases; There were portal vein thrombosis;
- Patients with positive serum HIV antibody;
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 |
|---|---|---|
| UC-MSCsUsage: The stem cell preparation in this study is used intravenously in the elbow. Dose: The dose of stem cell injection in this clinical study is set at 1×10^6/Kg/time per injection Duration: 5 injections per trial group for the entire duration of the course, at 1st treatment, 2-week, 4-week, 16-week, and 24-week respectively | Biological | Experimental |
| Saline solutionUsage: The saline solution in this study is used intravenously in the elbow. Dose: The dose of saline solution in this clinical study is set at 250ml/time per injection Duration: 5 injections per person for the entire duration of the course, at 1st treatment, 2-week, 4-week, 16-week, and 24-week respectively | Biological | Comparator |
Primary outcome
FibroScan
Time frame: Change from Baseline Liver stiffness at week 24
Parameters of liver stiffness
IV-C
Time frame: Change from Baseline at week 24
Change of Serum hepatic fibrosis indexes
HA
Time frame: Change from Baseline at week 24
Change of Serum hepatic fibrosis indexes
LN
Time frame: Change from Baseline at week 24
Change of Serum hepatic fibrosis indexes
PC-III
Time frame: Change from Baseline at week 24
Change of Serum hepatic fibrosis indexes
Hepatic histopathologic examination
Time frame: Change from Baseline at week 24
Status of the liver
IgG
Time frame: Change from Baseline at week 24
Change of humoral immunity
IgA
Time frame: Change from Baseline at week 24
Change of humoral immunity
IgM
Time frame: Change from Baseline at week 24
Change of humoral immunity
IgE
Time frame: Change from Baseline at week 24
Change of humoral immunity
C3
Time frame: Change from Baseline at week 24
Change of humoral immunity
C4
Time frame: Change from Baseline at week 24
Change of humoral immunity
CD3
Time frame: Change from Baseline at week 24
Change of cellular immunity
CD4
Time frame: Change from Baseline at week 24
Change of cellular immunity
CD8
Time frame: Change from Baseline at week 24
Change of cellular immunity
CD19
Time frame: Change from Baseline at week 24
Change of cellular immunity
CD16+56
Time frame: Change from Baseline at week 24
Change of cellular immunity
7 secondary outcomes
ALB
Time frame: Change from Baseline at week 24
ALT
Time frame: Change from Baseline at week 24
AST
Time frame: Change from Baseline at week 24
TBIL
Time frame: Change from Baseline at week 24
DBIL
Time frame: Change from Baseline at week 24
HBV-DNA
Time frame: Change from Baseline at week 24
Change of ultrasound examination of liver
Time frame: Change from Baseline at week 24
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2022.
- Individual participant dataSharing planned: Yes. After approval from the steering committee and the Human Genetic Resources Administration of China, this trial data can be shared with qualifying researchers who submit a proposal with a valuable research question. A contract should besigned.
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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.
YINGAN JIANG principal investigator
Renmin Hospital of Wuhan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing UC-MSCs and Saline solution in people with Cirrhosis Due to Hepatitis B, run by Renmin Hospital of Wuhan University at 1 site in China.
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 4 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 19 Aug 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact LICHAO YAO (+86 13638685006, ylc9409@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
FibroScan (time frame: Change from Baseline Liver stiffness at week 24). The study lists 17 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Aug 2022.