Liver CirrhosisNCT05106972
Umbilical Cord Mesenchymal Stem Cell Transplantation for Decompensated Hepatitis B Cirrhosis
A study testing UC-MSC infusion in people with Liver Cirrhosis, run by Asia Stem Cell Regenerative Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
This study aims to evaluate the safety and clinical efficacy of umbilical cord mesenchymal stem cell transplantation for decompensated hepatitis B cirrhosis. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Liver Cirrhosis
- What is being tested?
- UC-MSC infusion
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2021to 31 Dec 2025
- Phase
- Interventional
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Aged between 20 and 60 (male or female)
- Diagnosed chronic decompensated hepatitis B cirrhosis with a course of more than 5 years
- Not suitable for liver transplantation or there is no donor liver source
- No serious bleeding tendency or active bleeding
- No hepatic encephalopathy
- After strict medical conservative treatment for more than 6 months, there was no relief of symptoms or significant improvement of quality of life score
- Subjects voluntarily participate in this study and sign informed consent
Who cannot join
- Be less than 20 years old or more than 60 years old
- Cirrhosis caused by other causes such as alcoholic hepatitis, hepatitis C virus and autoimmune hepatitis
- Found liver malignant tumor or the family history of liver malignant tumor in the third generation of their direct relatives
- Patients with hypersplenism who need splenectomy
- History of tumors in other organs
- PT prolongation is greater than 3 seconds
Show all 12Show fewer
- Use of human serum albumin within 3 weeks prior to clinical registration
- Clinically significant upper gastrointestinal bleeding events occurred within 4 weeks before clinical registration
- Spontaneous peritonitis
- Active infection (viral or bacterial)
- Pregnant or lactating women
- The researcher considers it inappropriate to participate in this study
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Haikou People's Hospital
Haikou
Xiaoxi Huang, PHD, 86-0898-66151200, huangxiaoxi@xibaozhiliao.cn
About this study
Official title: A Single Center, Prospective Study of Umbilical Cord Mesenchymal Stem Cell Transplantation for Decompensated Hepatitis B Cirrhosis
This study aims to evaluate the safety and clinical efficacy of umbilical cord mesenchymal stem cell transplantation for decompensated hepatitis B cirrhosis.
- Conditions
- Liver Cirrhosis
- Being tested
- UC-MSC infusion
- Medical subject headings
- Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UC-MSC infusionDrug
UC-MSC infusion by introvenus
| Study group | Role | What they receive |
|---|---|---|
| UC-MSC infusion | Experimental | UC-MSC infusion by intravenus, 1*10^8 cells/dose, 2 doses (apart from 24weeks) Receives: Drug: UC-MSC infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with abnormal Total bilirubin
Measured: Changes from baseline to 72 weeks
Number of Participants with abnormal albumin
Measured: Changes from baseline to 72 weeks
Ishak Inflammation Rating System
Measured: Changes from baseline to 72 weeks
Ishak Fibrosis Score
Measured: Changes from baseline to 72 weeks
Secondary outcomes (8)
Overall survival (OS)
Measured: Changes from baseline to 72 weeks
HBV-DNA
Measured: Changes from baseline to 72 weeks
incidence of liver cancer
Measured: Changes from baseline to 72 weeks
Number of Participants with abnormal immunoglobulin
Measured: Changes from baseline to 72 weeks
portal vein flow rate
Measured: Changes from baseline to 72 weeks
portal vein width
Measured: Changes from baseline to 72 weeks
abdominal volume
Measured: Changes from baseline to 72 weeks
Number of Participants with abnormal coagulation function
Measured: Changes from baseline to 72 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2021
- Study start1 Dec 2021 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asia Stem Cell Regenerative Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05106972
- Sponsor's protocol ID
- SCT20181032
- Status last verified
- Oct 2021
- First submitted
- 19 Sep 2021
- Last updated
- 4 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center, Prospective Study of Umbilical Cord Mesenchymal Stem Cell Transplantation for Decompensated Hepatitis B Cirrhosis
- ClinicalTrials.gov ID
- NCT05106972
- Acronym / sponsor ID
- SCT20181032
- Conditions
- Liver Cirrhosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Asia Stem Cell Regenerative Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Dec 2021 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 4 Nov 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.
This study aims to evaluate the safety and clinical efficacy of umbilical cord mesenchymal stem cell transplantation for decompensated hepatitis B cirrhosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| UC-MSC infusion | Experimental | Drug: UC-MSC infusionUC-MSC infusion by intravenus, 1*10^8 cells/dose, 2 doses (apart from 24weeks) |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Aged between 20 and 60 (male or female)
- Diagnosed chronic decompensated hepatitis B cirrhosis with a course of more than 5 years
- Not suitable for liver transplantation or there is no donor liver source
- No serious bleeding tendency or active bleeding
- No hepatic encephalopathy
Key exclusion criteria (12 listed)
- Be less than 20 years old or more than 60 years old
- Cirrhosis caused by other causes such as alcoholic hepatitis, hepatitis C virus and autoimmune hepatitis
- Found liver malignant tumor or the family history of liver malignant tumor in the third generation of their direct relatives
- Patients with hypersplenism who need splenectomy
- History of tumors in other organs
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-MSC infusionUC-MSC infusion by introvenus | Drug | UC-MSC infusion |
Primary outcome
Number of Participants with abnormal Total bilirubin
Time frame: Changes from baseline to 72 weeks
Number of Participants with abnormal albumin
Time frame: Changes from baseline to 72 weeks
Ishak Inflammation Rating System
Time frame: Changes from baseline to 72 weeks
Ishak Fibrosis Score
Time frame: Changes from baseline to 72 weeks
8 secondary outcomes
Overall survival (OS)
Time frame: Changes from baseline to 72 weeks
HBV-DNA
Time frame: Changes from baseline to 72 weeks
incidence of liver cancer
Time frame: Changes from baseline to 72 weeks
Number of Participants with abnormal immunoglobulin
Time frame: Changes from baseline to 72 weeks
portal vein flow rate
Time frame: Changes from baseline to 72 weeks
portal vein width
Time frame: Changes from baseline to 72 weeks
abdominal volume
Time frame: Changes from baseline to 72 weeks
Number of Participants with abnormal coagulation function
Time frame: Changes from baseline to 72 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2021.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing UC-MSC infusion in people with Liver Cirrhosis, run by Asia Stem Cell Regenerative Pharmaceutical Co., Ltd. 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 7 inclusion and 12 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 4 Nov 2021. 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.
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 Xiaoxi Huang, PHD (86-0898-66151200, huangxiaoxi@xibaozhiliao.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with abnormal Total bilirubin (time frame: Changes from baseline to 72 weeks). The study lists 4 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 4 Nov 2021.