HBVEarly Phase 1CS-hUC-MSCsNCT05442437
Clinical Study of hUC-MSCs Treating Decompensated Liver Cirrhosis With HBV
A Early Phase 1 study testing hUCMSCs in people with HBV, run by Zhongnan Hospital at 1 site in China.
Trial summary
The purpose of this study was to observe the safety ,tolerability ,Efficacy dose of human umbilical cord mesenchymal stem cells in patients of decompensated liver cirrhosis with HBV. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- HBV
- What is being tested?
- hUCMSCs
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 8 Sep 2019to 31 Dec 2022
- Phase
- Early Phase 1
- 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
- Aged between 18 and 65 (including 18 and 65), regardless of gender;
- Decompensated stage of viral hepatitis B cirrhosis;
- The effect of conventional medical treatment is not good, and the condition is repeated;
- ALB < 35g/L, TBIL < 170μmol/L, INR > 30%, Child-pugh score ≥7; MELD score ≤15;
- Hgb > 70g/L, PLT > 3×109/L;
- Unconditional acceptance for liver transplantation; 7）Participate in the clinical study voluntarily, cooperate with doctors to carry out the study, and sign informed consent.
Who cannot join
- With spontaneous peritonitis or other serious infection;
- Patients with hepatorenal syndrome;
- Severe hepatic encephalopathy, massive hemorrhage of digestive tract or varicose 4. vein in recent 1 month;
- Portal vein thrombosis; Complicated with serious diseases of heart, lung, kidney,
- blood and endocrine system;
- HIV positive;
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- Positive autoantibodies related to autoimmune liver disease;
- Presence of liver or any type of malignant tumor;
- Pregnant women, breast-feeding women or those with recent birth plans;
- Those who have a history of alcohol and drug abuse and failed to get rid of it effectively;
- Participated in other clinical trials within 3 months prior to enrollment;
- Participated in clinical research on stem cells;
- Unwillingness to sign informed consent;
- Other conditions that the investigator considers inappropriate for patients to participate in this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Study of Human Umbilical Cord Mesenchymal Stem Cells for Treating Decompensated Liver Cirrhosis Associated With HBV
The purpose of this study was to observe the safety ,tolerability ,Efficacy dose of human umbilical cord mesenchymal stem cells in patients of decompensated liver cirrhosis with HBV.
Read the detailed description
Investigators plan to recruit 24 voluntary patients of decompensate liver cirrhosis with HBV, dividing them into 3 group：1) low-dose group: 100mL with 2.5×10^7 cells；2) medium-dose group: 100mL with 5.0×10^7 cells；3) high-dose group: 100mL with 1.0×10^8 cells. Each group contains 8 patients. Investigators treat the participants with human umbilical cord mesenchymal stem cells via venous transfusion. First investigators arrange a whole test for participants, such as vital sign examination, laboratory test, ECG, CT, MRI, ultrasound etc. Investigators screen these patients with a complete eligibility criteria. Then investigators proceed the therapy in the 1st, 8th and 15th day. There are 8 times of follow-up visit for these patients, 4 times of those are proceeded during the hospitalization, while other 4 times happens after the discharge. The follow-up visit includes vital sign examination, laboratory test, ECG, CT, MRI, ultrasound, Child-Pugh grade, MELD grade, SF-36 test. These follow-up visit last 24 weeks since the first treatment. After that, investigators also arrange a survival visit through phone or clinic each 6 months, lasting another 1.5 years. The main object of this research is investigating the survival rate, promotion of the liver function, improvement of health, safety of hUC-MSCs, tolerability of patients, for exploring a new way for the therapy of decompensated liver cirrhosis with HBV.
- Conditions
- HBV
- Being tested
- hUCMSCs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hUCMSCsBiological
Human umbilical cord mesenchymal stem cell preparation, 100ml/ bag, containing 2.5×107 cells, 5.0×107 cells, 1.0 x 108 cells
| Study group | Role | What they receive |
|---|---|---|
| Low-dose group | Experimental | 100mL human umbilical cord mesenchymal stem cell preparation, containing 2.5×10^7 cells. Receives: Biological: hUCMSCs |
| medium-dose group | Experimental | 100mL human umbilical cord mesenchymal stem cell preparation, containing 5.0×10^7 cells. Receives: Biological: hUCMSCs |
| High-dose group | Experimental | 100mL human umbilical cord mesenchymal stem cell preparation, containing 1.0×10^8 cells. Receives: Biological: hUCMSCs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum albumin in g/L
We compare this index in first day, 4th, 8th, 12th and 24th week, to describe their tendency.
Measured: 24 weeks
alanine aminotransferase in U/L
We compare this index in first day, 4th, 8th, 12th and 24th week, to describe their tendency.
Measured: 24 weeks
aspartate aminotransferase in U/L
We compare this index in first day, 4th, 8th, 12th and 24th week, to describe their tendency.
Measured: 24 weeks
cholinesterase in U/L
We compare this index in first day, 4th, 8th, 12th and 24th week, to describe their tendency.
Measured: 24 weeks
Total bilirubin in μmol/L
We compare this index in first day, 4th, 8th, 12th and 24th week, to describe their tendency.
Measured: 24 weeks
Direct bilirubin in μmol/L
We compare this index in first day, 4th, 8th, 12th and 24th week, to describe their tendency.
Measured: 24 weeks
Serum cholesterol in mmol/L
We compare this index in first day, 4th, 8th, 12th and 24th week, to describe their tendency.
Measured: 24 weeks
Prothrombin activity in percentage
We compare this index in first day, 4th, 8th, 12th and 24th week, to describe their tendency.
Measured: 24 weeks
Antithrombin in mg/L
We compare this index in first day, 4th, 8th, 12th and 24th week, to describe their tendency.
Measured: 24 weeks
Secondary outcomes (18)
survival rate
survival rate after 2 years since the first therapy
Measured: 2 years
Child-Pugh grade
Child-Pugh grade is defined according to hepatic encephalopathy, ascites，serum albumin, total bilirubin, prothrombin time. Score 5-6 is grade A. Score 7-9 is grade B. Score 10-15 is grade C.
We compare the Child-Pugh grade in first day, 4th, 8th, 12th and 24th week, to describe its tendency.
Measured: 24 weeks
Rate of weight change
We compare the weight in first day, 4th, 8th, 12th and 24th week, to describe its tendency.
Measured: 24 weeks
Ascites
We test the ascites via ultrasound, CT and MRI. We classify the ascite level into none, low and high.
We compare the Child-Pugh grade in first day, 4th, 8th, 12th and 24th week, to describe its tendency.
Measured: 24 weeks
clinical symptoms
Including lower limb edema, hematemesis, jaundice, fatigue, poor appetite. We compare these symptoms in first day, 4th, 8th, 12th and 24th week, to describe their tendency.
Measured: 24 weeks
Th1 cells in percentage
We compare this index in first day, 4th, 8th, 12th and 24th week, to describe their tendency.
Measured: 24 weeks
Th2 cells in percentage
We compare this index in first day, 4th, 8th, 12th and 24th week, to describe their tendency.
Measured: 24 weeks
Natural killer T cells in percentage
We compare this index in first day, 4th, 8th, 12th and 24th week, to describe their tendency.
Measured: 24 weeks
Interleukin-1β cells in pg/mL
We compare this index in first day, 4th, 8th, 12th and 24th week, to describe their tendency.
Measured: 24 weeks
Interleukin-4 cells in pg/mL
We compare this index in first day, 4th, 8th, 12th and 24th week, to describe their tendency.
Measured: 24 weeks
Interleukin-6 cells in pg/mL
We compare this index in first day, 4th, 8th, 12th and 24th week, to describe their tendency.
Measured: 24 weeks
Interleukin-8 cells in pg/mL
We compare this index in first day, 4th, 8th, 12th and 24th week, to describe their tendency.
Measured: 24 weeks
Interleukin-12 cells in pg/mL
We compare this index in first day, 4th, 8th, 12th and 24th week, to describe their tendency.
Measured: 24 weeks
Interleukin-15 cells in pg/mL
We compare this index in first day, 4th, 8th, 12th and 24th week, to describe their tendency.
Measured: 24 weeks
Interleukin-17A cells in pg/mL
We compare this index in first day, 4th, 8th, 12th and 24th week, to describe their tendency.
Measured: 24 weeks
Medical images
Ultrasound in first day, 4th, 8th, 12th and 24th; enhanced CT scanning and/or MRI-Primovist scanning in first day, 12th week and 24th week.
Measured: 24 weeks
The Medical outcomes study 36-item Short Form Health Survay scale (SF-36 scale)
SF-36 scale is a measurement for patients' living quality. The scores contain 8 parts, including physical functioning, role-physica, bodily pain, general health, vitality, social functioning, role-emotional and mental health. Conversion score=(actual score-minimum score in this part)/(maximum score in this part-minimum score in this part)*100. Score of each part range from 0 to 100. The higher score means more healthy. We proceed SF-36 test in 12th week and 24th week
Measured: 24 weeks
MELD score
MELD=3.78*Ln(total bilirubin mg/dL)+11.2*Ln(INR)+9.57*Ln(serum creatine mg/dL)+6.43 (for HBV patient) We compare MELD score in first day, 4th, 8th, 12th and 24th week, to describe its tendency.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2022
- Study start8 Sep 2019
- Primary completion1 Jul 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HBVStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- We allocate 24 participants into 3 group, low-dose, medium-dose and high-dose group. It is going to proceeded sequential from low-dose group to high-dose group. Next group is allowed to be started only the last group has been finished. 1. Low-dose group: 100mL human umbilical cord mesenchymal stem cell preparation, containing 2.5×10\^7 cells; 2. medium-dose group: 100mL human umbilical cord mesenchymal stem cell preparation, containing 5.0×10\^7 cells; 3. High-dose group: 100mL human umbilical cord mesenchymal stem cell preparation, containing 1.0×10\^8 cells
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhongnan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05442437
- Sponsor's protocol ID
- 03
- Acronym
- CS-hUC-MSCs
- Status last verified
- Dec 2021
- First submitted
- 13 Apr 2022
- Last updated
- 1 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Human Umbilical Cord Mesenchymal Stem Cells for Treating Decompensated Liver Cirrhosis Associated With HBV
- ClinicalTrials.gov ID
- NCT05442437
- Acronym / sponsor ID
- CS-hUC-MSCs / 03
- Conditions
- HBV
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Zhongnan HospitalUniversity, hospital or other
- Study start
- 8 Sep 2019 (actual)
- Primary completion
- 1 Jul 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 5 Jul 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.
The purpose of this study was to observe the safety ,tolerability ,Efficacy dose of human umbilical cord mesenchymal stem cells in patients of decompensated liver cirrhosis with HBV.
Detailed description
Investigators plan to recruit 24 voluntary patients of decompensate liver cirrhosis with HBV, dividing them into 3 group：1) low-dose group: 100mL with 2.5×10^7 cells；2) medium-dose group: 100mL with 5.0×10^7 cells；3) high-dose group: 100mL with 1.0×10^8 cells. Each group contains 8 patients. Investigators treat the participants with human umbilical cord mesenchymal stem cells via venous transfusion. First investigators arrange a whole test for participants, such as vital sign examination, laboratory test, ECG, CT, MRI, ultrasound etc. Investigators screen these patients with a complete eligibility criteria. Then investigators proceed the therapy in the 1st, 8th and 15th day. There are 8 times of follow-up visit for these patients, 4 times of those are proceeded during the hospitalization, while other 4 times happens after the discharge. The follow-up visit includes vital sign examination, laboratory test, ECG, CT, MRI, ultrasound, Child-Pugh grade, MELD grade, SF-36 test. These follow-up visit last 24 weeks since the first treatment. After that, investigators also arrange a survival visit through phone or clinic each 6 months, lasting another 1.5 years. The main object of this research is investigating the survival rate, promotion of the liver function, improvement of health, safety of hUC-MSCs, tolerability of patients, for exploring a new way for the therapy of decompensated liver cirrhosis with HBV.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- We allocate 24 participants into 3 group, low-dose, medium-dose and high-dose group. It is going to proceeded sequential from low-dose group to high-dose group. Next group is allowed to be started only the last group has been finished. 1. Low-dose group: 100mL human umbilical cord mesenchymal stem cell preparation, containing 2.5×10^7 cells; 2. medium-dose group: 100mL human umbilical cord mesenchymal stem cell preparation, containing 5.0×10^7 cells; 3. High-dose group: 100mL human umbilical cord mesenchymal stem cell preparation, containing 1.0×10^8 cells
| Arm | Type | Receives |
|---|---|---|
| Low-dose group | Experimental | Biological: hUCMSCs100mL human umbilical cord mesenchymal stem cell preparation, containing 2.5×10^7 cells. |
| medium-dose group | Experimental | Biological: hUCMSCs100mL human umbilical cord mesenchymal stem cell preparation, containing 5.0×10^7 cells. |
| High-dose group | Experimental | Biological: hUCMSCs100mL human umbilical cord mesenchymal stem cell preparation, containing 1.0×10^8 cells. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged between 18 and 65 (including 18 and 65), regardless of gender;
- Decompensated stage of viral hepatitis B cirrhosis;
- The effect of conventional medical treatment is not good, and the condition is repeated;
- ALB < 35g/L, TBIL < 170μmol/L, INR > 30%, Child-pugh score ≥7; MELD score ≤15;
- Hgb > 70g/L, PLT > 3×109/L;
Key exclusion criteria (14 listed)
- With spontaneous peritonitis or other serious infection;
- Patients with hepatorenal syndrome;
- Severe hepatic encephalopathy, massive hemorrhage of digestive tract or varicose 4. vein in recent 1 month;
- Portal vein thrombosis; Complicated with serious diseases of heart, lung, kidney,
- blood and endocrine system;
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 |
|---|---|---|
| hUCMSCsHuman umbilical cord mesenchymal stem cell preparation, 100ml/ bag, containing 2.5×107 cells, 5.0×107 cells, 1.0 x 108 cells | Biological | High-dose group, Low-dose group, medium-dose group |
Primary outcome
Serum albumin in g/L
Time frame: 24 weeks
We compare this index in first day, 4th, 8th, 12th and 24th week, to describe their tendency.
alanine aminotransferase in U/L
Time frame: 24 weeks
We compare this index in first day, 4th, 8th, 12th and 24th week, to describe their tendency.
aspartate aminotransferase in U/L
Time frame: 24 weeks
We compare this index in first day, 4th, 8th, 12th and 24th week, to describe their tendency.
cholinesterase in U/L
Time frame: 24 weeks
We compare this index in first day, 4th, 8th, 12th and 24th week, to describe their tendency.
Total bilirubin in μmol/L
Time frame: 24 weeks
We compare this index in first day, 4th, 8th, 12th and 24th week, to describe their tendency.
Direct bilirubin in μmol/L
Time frame: 24 weeks
We compare this index in first day, 4th, 8th, 12th and 24th week, to describe their tendency.
Serum cholesterol in mmol/L
Time frame: 24 weeks
We compare this index in first day, 4th, 8th, 12th and 24th week, to describe their tendency.
Prothrombin activity in percentage
Time frame: 24 weeks
We compare this index in first day, 4th, 8th, 12th and 24th week, to describe their tendency.
Antithrombin in mg/L
Time frame: 24 weeks
We compare this index in first day, 4th, 8th, 12th and 24th week, to describe their tendency.
18 secondary outcomes
survival rate
Time frame: 2 years
Child-Pugh grade
Time frame: 24 weeks
Rate of weight change
Time frame: 24 weeks
Ascites
Time frame: 24 weeks
clinical symptoms
Time frame: 24 weeks
Th1 cells in percentage
Time frame: 24 weeks
Th2 cells in percentage
Time frame: 24 weeks
Natural killer T cells in percentage
Time frame: 24 weeks
Interleukin-1β cells in pg/mL
Time frame: 24 weeks
Interleukin-4 cells in pg/mL
Time frame: 24 weeks
Interleukin-6 cells in pg/mL
Time frame: 24 weeks
Interleukin-8 cells in pg/mL
Time frame: 24 weeks
Interleukin-12 cells in pg/mL
Time frame: 24 weeks
Interleukin-15 cells in pg/mL
Time frame: 24 weeks
Interleukin-17A cells in pg/mL
Time frame: 24 weeks
Medical images
Time frame: 24 weeks
The Medical outcomes study 36-item Short Form Health Survay scale (SF-36 scale)
Time frame: 24 weeks
MELD score
Time frame: 24 weeks
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 1 Dec 2023.
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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?
A Early Phase 1 study testing hUCMSCs in people with HBV, run by Zhongnan Hospital 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 6 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: finished, as of the sponsor's last update on 1 Dec 2023. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Serum albumin in g/L (time frame: 24 weeks). The study lists 9 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 1 Dec 2023.