Alcoholic CirrhosisPhase 1NCT05155657
Study of Decompensated Alcoholic Cirrhosis Treatment by Stem Cells
A Phase 1 study testing Conventional therapy plus low dose UCMSCs treatment, Conventional therapy plus medium dose UCMSCs treatment and Conventional therapy plus high dose UCMSCs treatment in people with Alcoholic Cirrhosis, run by Yantai Yuhuangding Hospital at 1 site in China.
Trial summary
The main purpose of this study is to evaluate the safety and tolerance of umbilical cord mesenchymal stem cells (UCMSCs) in patients with decompensated alcoholic cirrhosis, and to provide dose basis for subsequent clinical study design. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Alcoholic Cirrhosis
- What is being tested?
- Conventional therapy plus low dose UCMSCs treatment, Conventional therapy plus medium dose UCMSCs treatment and Conventional therapy plus high dose UCMSCs treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- 13 Jun 2022to 25 Dec 2024
- Phase
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18~60 years old;
- The subject was diagnosed as decompensated alcoholic liver cirrhosis, according to the Guidelines for the Diagnosis and Treatment of Liver Cirrhosis and the Guidelines for the Prevention and Treatment of Alcoholic Liver Disease (2018);
- The subject was previously diagnosed but treatment is ineffective;
- Liver function was in child Pugh grade A or MELD score < 12;
- Intermittent albumin supplementation and diuretic treatment are required;
- The subject's Albumin level is less than 35g/L, total bilirubin is smaller than 10 times of the upper limit of normal value (hepatocyte hepatitis), or smaller than 15 times of the upper limit of normal value (cholestatic hepatitis or hepatocyte combined with cholestatic hepatitis), prothrombin activity is over 40% (grade II or lower hepatic encephalopathy has been controlled);
- No history of gastrointestinal hemorrhage in the past month;
- The subject understand and voluntarily sign the informed consent.
Who cannot join
- The subject is allergic physique, with a history of drug or food allergies, especially those who are allergic to umbilical cord mesenchymal stem cells and any components in excipients;
- The subject suffer acute attack of gastrointestinal bleeding, hepatic encephalopathy, hepatorenal syndrome or infection;
- The subject suffer systemic infection or severe infection during screening;
- Abnormal laboratory examinations results, including blood routine: peripheral blood white blood cell count <2.0×10^9/L or >12×10^9/L, hemoglobin (Hb) is less than 70% lower limit of the normal value, platelets <50×10^9/L ; Liver function: ALT or AST> 5 times the upper limit of normal; Renal function: Serum Creatinine (sCr)> 1.5 times the upper limit of normal; in case of abnormality, test shall be repeated;
- Those who were positive for Hepatitis B surface Antigen (HBsAg) or Hepatitis C virus (HCV) antibody, Human Immunodeficiency Virus (HIV) antibody or syphilis antibody during screening;
- Subjects suffer from serious, progressive, or uncontrolled diseases of important organs (including cardiovascular system, liver, lung and kidney), and other autoimmune diseases, malignant tumors, or a history of previous tumors, as well as other diseases that researchers believe that they are not suitable to participate in this clinical study.
Show all 11Show fewer
- Subject who has received stem cell therapy within 6 months before the screening;
- Subject who has received biotherapy or participated in other clinical studies within 3 months before screening;
- Female subjects who are pregnant, lactating, or premenopausal subject who failed to take medically approved non-drug contraceptive measures (such as intrauterine device, condom, female sterilization) during treatment and within 6 months after the treatment; or have a pregnancy plan within 6 months after the end of the study;
- Male subjects who fail to take medically approved non-drug contraceptive measures (such as male sterilization or condom) during the treatment period and within 6 months after the end of the treatment;
- Other factors that the researchers believe are not suitable for entering the study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Yantai Yuhuangding Hospital
Yantai, Shandong, 264000
Jun Cui, MD, 86 05356691999 ext. 82730, cuijun89@163.com
Peiwen Lian, PhD, 86 05356691999 ext. 82708, lianpeiwen@.qqcom
About this study
Official title: A Pilot Clinical Study to Evaluate Safety, Tolerability and Preliminary Efficacy of Intravenous Infusion of Umbilical Cord Mesenchymal Stem Cell in the Treatment of Decompensated Alcoholic Cirrhosis
The main purpose of this study is to evaluate the safety and tolerance of umbilical cord mesenchymal stem cells (UCMSCs) in patients with decompensated alcoholic cirrhosis, and to provide dose basis for subsequent clinical study design. We will also explore the possible mechanism of UCMSCs in the treatment of decompensated alcoholic cirrhosis (DAC).
Read the detailed description
This study adopted a single-center, single-arm, single-dose combined multiple-dose administration, and dose-escalation clinical trial design to evaluate the safety, tolerability and preliminary effectiveness of UCMSCs in the treatment of patients with decompensated liver cirrhosis. Patients were recruited into three different dose groups, and 12 subjects were enrolled in each group. The subjects of each group will receive 0.5×10^6 cells/kg, 1.0×10^6 cells/kg, and 2.0×10^6 cells/kg respectively. According to the principle of dose escalation, subjects preset to low-dose will receive the administration first. Each group will receive only one corresponding dose for safety and tolerability check. The subjects will be observed for 21 days after the initial dose due to limited proliferation or differentiation potential and relatively low immunogenicity of mesenchymal stem cell products. The safety measures will be discussed by the Data Safety and Monitoring Board (DSMB) to determine whether subjects who have received a single dose will proceed with subsequent injections. Once all subjects in the lower-dose group have completed the initial administration and observed for 21 days. The DSMB will decided whether to proceed with the next-dose group. All subjects will receive routine drug treatment during the study. Primary endpoint: incidence and severity of cell therapy related adverse events from the beginning of treatment to the end of the follow-up. Secondary end point of the study includes: the change in Model For End-Stage Liver Disease (MELD) score of the subjects from baseline, at 1, 3, 6 and 12 months after the last administration; the overall survival rate at the 12th month after the last administration; Changes in liver function compared with baseline at 1, 3, 6 and 12 months after the last administration; changes of child Pugh score compared with baseline at 1, 3, 6 and 12 months after the last administration; and the change of Karnofsky Performance Status Scale (KPS) score from baseline at 1, 3, 6 and 12 months after the last administration.
- Conditions
- Alcoholic Cirrhosis
- Being tested
- Conventional therapy plus low dose UCMSCs treatment, Conventional therapy plus medium dose UCMSCs treatment, Conventional therapy plus high dose UCMSCs treatment
- Medical subject headings
- Liver Cirrhosis, Alcoholic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional therapy plus low dose UCMSCs treatmentBiological
Patients will receive the conventional therapy plus low dose UCMSCs treatment (0.5×10^6 UCMSCs/kg body)
Conventional therapy plus medium dose UCMSCs treatmentBiological
Patients will receive conventional therapy plus medium dose UCMSCs treatment (1×10^6 UCMSCs/kg body)
Conventional therapy plus high dose UCMSCs treatmentBiological
Patients will receive conventional therapy plus high dose UCMSCs treatment (2×10^6 UCMSCs/kg body)
| Study group | Role | What they receive |
|---|---|---|
| Low dose umbilical cord mesenchymal stem cells (UCMSCs) | Experimental | Not described Receives: Biological: Conventional therapy plus low dose UCMSCs treatment |
| Medium dose UCMSCs | Experimental | Not described Receives: Biological: Conventional therapy plus medium dose UCMSCs treatment |
| High dose UCMSCs | Experimental | Not described Receives: Biological: Conventional therapy plus high dose UCMSCs treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity and incidence of adverse events (SIAE) on the 3rd day after the first administration
According to the evaluation criteria of common adverse events (CTCAE v5.0), any AE occurred in all subjects during the clinical study, including abnormalities in clinical symptoms and vital signs and abnormalities in laboratory examination was observed.
Measured: The 3rd day after the first administration
1 week SIAE after the first administration
According to the evaluation criteria of common adverse events (CTCAE v5.0), any AE occurred in all subjects during the clinical study, including abnormalities in clinical symptoms and vital signs and abnormalities in laboratory examination was observed.
Measured: 1 week after the first administration
3 weeks SIAE after the first administration
According to the evaluation criteria of common adverse events (CTCAE v5.0), any AE occurred in all subjects during the clinical study, including abnormalities in clinical symptoms and vital signs and abnormalities in laboratory examination was observed.
Measured: 3 week after the first administration
3 week SIAE after the the second administration
According to the evaluation criteria of common adverse events (CTCAE v5.0), any AE occurred in all subjects during the clinical study, including abnormalities in clinical symptoms and vital signs and abnormalities in laboratory examination was observed.
Measured: 3 weeks after the the second administration
1 month SIAE after the last administration
According to the evaluation criteria of common adverse events (CTCAE v5.0), any AE occurred in all subjects during the clinical study, including abnormalities in clinical symptoms and vital signs and abnormalities in laboratory examination was observed.
Measured: 1 month after the last administration
3 months SIAE after the last administration
According to the evaluation criteria of common adverse events (CTCAE v5.0), any AE occurred in all subjects during the clinical study, including abnormalities in clinical symptoms and vital signs and abnormalities in laboratory examination was observed.
Measured: 3 months after the last administration
6 months SIAE after the last administration
According to the evaluation criteria of common adverse events (CTCAE v5.0), any AE occurred in all subjects during the clinical study, including abnormalities in clinical symptoms and vital signs and abnormalities in laboratory examination was observed.
Measured: 6 months after the last administration
12 months SIAE after the last administration
According to the evaluation criteria of common adverse events (CTCAE v5.0), any AE occurred in all subjects during the clinical study, including abnormalities in clinical symptoms and vital signs and abnormalities in laboratory examination was observed.
Measured: 12 months after the last administration
24 months SIAE after the last administration
According to the evaluation criteria of common adverse events (CTCAE v5.0), any AE occurred in all subjects during the clinical study, including abnormalities in clinical symptoms and vital signs and abnormalities in laboratory examination was observed.
Measured: 24 months after the last administration
Secondary outcomes (9)
Child-Pugh score (effectiveness evaluation index)
The Child-Pugh grading standard is a grading standard commonly used in clinical practice to quantitatively evaluate the liver reserve function of patients with liver cirrhosis. Grading: 5~6 points for Grade A, 7~9 points for Grade B and 10~15 points for grade C;
Note:
For Primary Biliary Cirrhosis (PBC) or Primary Sclerosing Cholangitis (PSC): total bilirubin (umol/L): 17~68 is 1 point, 68~170 is 1 point, and >170 is 1 point; The Child-Pugh grading standard has been widely recognized by clinicians, and provides a specific clinical reference for the selection of treatment options for patients with liver cirrhosis and has important clinical value.
Measured: At baseline, 3, 7 and 21 days after the first administration, 21 days after the second administration (if any), and 1, 3, 6 and 12 months after the last administration.
Survival rate (effectiveness evaluation index)
Overall survival rate of participants in this study.
Measured: 12 months after the last administration.
Liver function (effectiveness evaluation index)
Indicators: Alanine transaminase (AST), Alanine transaminase (ALT)
Measured: Baseline, 3, 7, and 21 days after the first administration, 21 days after the second administration (if any), and 1, 3, 6, and 12 months after the last administration.
The Model for End-Stage Liver Disease (MELD) score (effectiveness evaluation index)
MELD is a numerical scale, ranging from 6 (less ill) to 40 (gravely ill), used for liver transplant candidates age 12 and older. It gives each person a 'score' (number) based on how urgently he or she needs a liver transplant within the next three months.
The number is calculated by a formula using three routine lab test results:
MELD score = 3.8×ln[bilirubin (mg/dl)] + 11.2×ln(INR) + 9.6×ln[Scr(mg/dl)] + 6.4×(Cause: Bile or alcoholic 0, other 1) Bilirubin (mg/dl) = Bilirubin (μmol/L)/17.1 Scr(mg/dl) = Scr(μmol/L)/88.4
Measured: Baseline, 3, 7, and 21 days after the first administration, 21 days after the second administration (if any), and 1, 3, 6, and 12 months after the last administration.
KPS score (effectiveness evaluation index)
KPS score is the Karnofsky (Karen, KPS, percentile method) functional status scoring standard. The higher the score, the better the health status, and the more the patient able to tolerate the side effects of treatment, hence a better curative effect. It is generally believed that a Karnofsky score above 80 is independent, which means the patient is able to take care of himself. Karnofsky score between 50 to 70 stands for a semi-independent status, that is, the patient is semi-self-care. A score of 50 means the patients require help from others. Those with a score greater than 80 are in better postoperative state and have a longer survival period.
The lower the score, the worse the health status. If the score is less than 60, many effective anti-tumor treatments cannot be implemented.
Measured: Baseline, 3, 7, and 21 days after the first administration, 21 days after the second administration (if any), and 1, 3, 6, and 12 months after the last administration.
Detection of Blood Coagulation Index of PT (effectiveness evaluation index)
To test the blood coagulation index of Prothrombin time (PT);
Measured: Baseline, 3, 7, and 21 days after the first administration, 21 days after the second administration (if any), and 1, 3, 6, and 12 months after the last administration.
Detection of Blood Coagulation Index of APTT (effectiveness evaluation index)
To test the blood coagulation index of activated partial thromboplastin time (APTT);
Measured: Baseline, 3, 7, and 21 days after the first administration, 21 days after the second administration (if any), and 1, 3, 6, and 12 months after the last administration.
Detection of Blood Coagulation Index of TT (effectiveness evaluation index)
To test the blood coagulation index of thrombin time (TT);
Measured: Baseline, 3, 7, and 21 days after the first administration, 21 days after the second administration (if any), and 1, 3, 6, and 12 months after the last administration.
Detection of Blood Coagulation Index of FIB (effectiveness evaluation index)
To test the blood coagulation index of fibrinogen (FIB);
Measured: Baseline, 3, 7, and 21 days after the first administration, 21 days after the second administration (if any), and 1, 3, 6, and 12 months after the last administration.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2021
- Study start13 Jun 2022
- Primary completion25 Dec 2024 (estimated)
- Study completion25 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alcoholic CirrhosisStudies 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yantai Yuhuangding Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jun Cui, MD, Principal investigator, Yantai Yuhuangding Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05155657
- Sponsor's protocol ID
- 2021-001
- Status last verified
- Mar 2023
- First submitted
- 19 Nov 2021
- Last updated
- 28 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Clinical Study to Evaluate Safety, Tolerability and Preliminary Efficacy of Intravenous Infusion of Umbilical Cord Mesenchymal Stem Cell in the Treatment of Decompensated Alcoholic Cirrhosis
- ClinicalTrials.gov ID
- NCT05155657
- Acronym / sponsor ID
- 2021-001
- Conditions
- Alcoholic Cirrhosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Yantai Yuhuangding HospitalUniversity, hospital or other
- Study start
- 13 Jun 2022 (actual)
- Primary completion
- 25 Dec 2024 (estimated)
- Study completion
- 25 Dec 2024 (estimated)
- First posted
- 13 Dec 2021 (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 main purpose of this study is to evaluate the safety and tolerance of umbilical cord mesenchymal stem cells (UCMSCs) in patients with decompensated alcoholic cirrhosis, and to provide dose basis for subsequent clinical study design. We will also explore the possible mechanism of UCMSCs in the treatment of decompensated alcoholic cirrhosis (DAC).
Detailed description
This study adopted a single-center, single-arm, single-dose combined multiple-dose administration, and dose-escalation clinical trial design to evaluate the safety, tolerability and preliminary effectiveness of UCMSCs in the treatment of patients with decompensated liver cirrhosis. Patients were recruited into three different dose groups, and 12 subjects were enrolled in each group. The subjects of each group will receive 0.5×10^6 cells/kg, 1.0×10^6 cells/kg, and 2.0×10^6 cells/kg respectively. According to the principle of dose escalation, subjects preset to low-dose will receive the administration first. Each group will receive only one corresponding dose for safety and tolerability check. The subjects will be observed for 21 days after the initial dose due to limited proliferation or differentiation potential and relatively low immunogenicity of mesenchymal stem cell products. The safety measures will be discussed by the Data Safety and Monitoring Board (DSMB) to determine whether subjects who have received a single dose will proceed with subsequent injections. Once all subjects in the lower-dose group have completed the initial administration and observed for 21 days. The DSMB will decided whether to proceed with the next-dose group. All subjects will receive routine drug treatment during the study. Primary endpoint: incidence and severity of cell therapy related adverse events from the beginning of treatment to the end of the follow-up. Secondary end point of the study includes: the change in Model For End-Stage Liver Disease (MELD) score of the subjects from baseline, at 1, 3, 6 and 12 months after the last administration; the overall survival rate at the 12th month after the last administration; Changes in liver function compared with baseline at 1, 3, 6 and 12 months after the last administration; changes of child Pugh score compared with baseline at 1, 3, 6 and 12 months after the last administration; and the change of Karnofsky Performance Status Scale (KPS) score from baseline at 1, 3, 6 and 12 months after the last administration.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low dose umbilical cord mesenchymal stem cells (UCMSCs) | Experimental | Biological: Conventional therapy plus low dose UCMSCs treatment |
| Medium dose UCMSCs | Experimental | Biological: Conventional therapy plus medium dose UCMSCs treatment |
| High dose UCMSCs | Experimental | Biological: Conventional therapy plus high dose UCMSCs treatment |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Age 18~60 years old;
- The subject was diagnosed as decompensated alcoholic liver cirrhosis, according to the Guidelines for the Diagnosis and Treatment of Liver Cirrhosis and the Guidelines for the Prevention and Treatment of Alcoholic Liver Disease (2018);
- The subject was previously diagnosed but treatment is ineffective;
- Liver function was in child Pugh grade A or MELD score < 12;
- Intermittent albumin supplementation and diuretic treatment are required;
Key exclusion criteria (11 listed)
- The subject is allergic physique, with a history of drug or food allergies, especially those who are allergic to umbilical cord mesenchymal stem cells and any components in excipients;
- The subject suffer acute attack of gastrointestinal bleeding, hepatic encephalopathy, hepatorenal syndrome or infection;
- The subject suffer systemic infection or severe infection during screening;
- Abnormal laboratory examinations results, including blood routine: peripheral blood white blood cell count <2.0×10^9/L or >12×10^9/L, hemoglobin (Hb) is less than 70% lower limit of the normal value, platelets <50×10^9/L ; Liver function: ALT or AST> 5 times the upper limit of normal; Renal function: Serum Creatinine (sCr)> 1.5 times the upper limit of normal; in case of abnormality, test shall be repeated;
- Those who were positive for Hepatitis B surface Antigen (HBsAg) or Hepatitis C virus (HCV) antibody, Human Immunodeficiency Virus (HIV) antibody or syphilis antibody during screening;
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 |
|---|---|---|
| Conventional therapy plus low dose UCMSCs treatmentPatients will receive the conventional therapy plus low dose UCMSCs treatment (0.5×10^6 UCMSCs/kg body) | Biological | Low dose umbilical cord mesenchymal stem cells (UCMSCs) |
| Conventional therapy plus medium dose UCMSCs treatmentPatients will receive conventional therapy plus medium dose UCMSCs treatment (1×10^6 UCMSCs/kg body) | Biological | Medium dose UCMSCs |
| Conventional therapy plus high dose UCMSCs treatmentPatients will receive conventional therapy plus high dose UCMSCs treatment (2×10^6 UCMSCs/kg body) | Biological | High dose UCMSCs |
Primary outcome
Severity and incidence of adverse events (SIAE) on the 3rd day after the first administration
Time frame: The 3rd day after the first administration
According to the evaluation criteria of common adverse events (CTCAE v5.0), any AE occurred in all subjects during the clinical study, including abnormalities in clinical symptoms and vital signs and abnormalities in laboratory examination was observed.
1 week SIAE after the first administration
Time frame: 1 week after the first administration
According to the evaluation criteria of common adverse events (CTCAE v5.0), any AE occurred in all subjects during the clinical study, including abnormalities in clinical symptoms and vital signs and abnormalities in laboratory examination was observed.
3 weeks SIAE after the first administration
Time frame: 3 week after the first administration
According to the evaluation criteria of common adverse events (CTCAE v5.0), any AE occurred in all subjects during the clinical study, including abnormalities in clinical symptoms and vital signs and abnormalities in laboratory examination was observed.
3 week SIAE after the the second administration
Time frame: 3 weeks after the the second administration
According to the evaluation criteria of common adverse events (CTCAE v5.0), any AE occurred in all subjects during the clinical study, including abnormalities in clinical symptoms and vital signs and abnormalities in laboratory examination was observed.
1 month SIAE after the last administration
Time frame: 1 month after the last administration
According to the evaluation criteria of common adverse events (CTCAE v5.0), any AE occurred in all subjects during the clinical study, including abnormalities in clinical symptoms and vital signs and abnormalities in laboratory examination was observed.
3 months SIAE after the last administration
Time frame: 3 months after the last administration
According to the evaluation criteria of common adverse events (CTCAE v5.0), any AE occurred in all subjects during the clinical study, including abnormalities in clinical symptoms and vital signs and abnormalities in laboratory examination was observed.
6 months SIAE after the last administration
Time frame: 6 months after the last administration
According to the evaluation criteria of common adverse events (CTCAE v5.0), any AE occurred in all subjects during the clinical study, including abnormalities in clinical symptoms and vital signs and abnormalities in laboratory examination was observed.
12 months SIAE after the last administration
Time frame: 12 months after the last administration
According to the evaluation criteria of common adverse events (CTCAE v5.0), any AE occurred in all subjects during the clinical study, including abnormalities in clinical symptoms and vital signs and abnormalities in laboratory examination was observed.
24 months SIAE after the last administration
Time frame: 24 months after the last administration
According to the evaluation criteria of common adverse events (CTCAE v5.0), any AE occurred in all subjects during the clinical study, including abnormalities in clinical symptoms and vital signs and abnormalities in laboratory examination was observed.
9 secondary outcomes
Child-Pugh score (effectiveness evaluation index)
Time frame: At baseline, 3, 7 and 21 days after the first administration, 21 days after the second administration (if any), and 1, 3, 6 and 12 months after the last administration.
Survival rate (effectiveness evaluation index)
Time frame: 12 months after the last administration.
Liver function (effectiveness evaluation index)
Time frame: Baseline, 3, 7, and 21 days after the first administration, 21 days after the second administration (if any), and 1, 3, 6, and 12 months after the last administration.
The Model for End-Stage Liver Disease (MELD) score (effectiveness evaluation index)
Time frame: Baseline, 3, 7, and 21 days after the first administration, 21 days after the second administration (if any), and 1, 3, 6, and 12 months after the last administration.
KPS score (effectiveness evaluation index)
Time frame: Baseline, 3, 7, and 21 days after the first administration, 21 days after the second administration (if any), and 1, 3, 6, and 12 months after the last administration.
Detection of Blood Coagulation Index of PT (effectiveness evaluation index)
Time frame: Baseline, 3, 7, and 21 days after the first administration, 21 days after the second administration (if any), and 1, 3, 6, and 12 months after the last administration.
Detection of Blood Coagulation Index of APTT (effectiveness evaluation index)
Time frame: Baseline, 3, 7, and 21 days after the first administration, 21 days after the second administration (if any), and 1, 3, 6, and 12 months after the last administration.
Detection of Blood Coagulation Index of TT (effectiveness evaluation index)
Time frame: Baseline, 3, 7, and 21 days after the first administration, 21 days after the second administration (if any), and 1, 3, 6, and 12 months after the last administration.
Detection of Blood Coagulation Index of FIB (effectiveness evaluation index)
Time frame: Baseline, 3, 7, and 21 days after the first administration, 21 days after the second administration (if any), and 1, 3, 6, and 12 months after the last administration.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 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.
Jun Cui, MD principal investigator
Yantai Yuhuangding Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Conventional therapy plus low dose UCMSCs treatment, Conventional therapy plus medium dose UCMSCs treatment and Conventional therapy plus high dose UCMSCs treatment in people with Alcoholic Cirrhosis, run by Yantai Yuhuangding 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 8 inclusion and 11 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 28 Mar 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?
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.
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 Jun Cui, MD (86 05356691999 ext. 82730, cuijun89@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severity and incidence of adverse events (SIAE) on the 3rd day after the first administration (time frame: The 3rd day after the first administration). 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 28 Mar 2023.