Decompensated CirrhosisPhase 1/2NCT02786017
Injectable Collagen Scaffold™ Combined With HUC-MSCs Transplantation for Patients With Decompensated Cirrhosis
A Phase 1/2 study testing Conventional therapy and Injectable Collagen Scaffold + HUC-MSCs in people with Decompensated Cirrhosis, run by Chinese Academy of Sciences at 1 site in China.
Trial summary
The purpose of this study is to assess the safety and efficacy of injectable collagen scaffold combined with human umbilical cord-derived mesenchymal stem cells (HUC-MSCs) transplantation in patients with Decompensated Cirrhosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Decompensated Cirrhosis
- What is being tested?
- Conventional therapy and Injectable Collagen Scaffold + HUC-MSCs
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- May 2016to Dec 2020
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must meet all of the following criteria:
- Subjects who are decompensated cirrhosis of any cause.
- Subjects are repeated exacerbations despite treatment and hospitalized more than once within one year because of complications of cirrhosis, (e.g., massive ascites, spontaneous bacterial peritonitis, gastrointestinal bleeding or hepatic encephalopathy).
- Need intermittent plasma albumin and oral diuretics supplement.
- Serum albumin <35 g/L, total bilirubin<170 μmol/L, prothrombin activity >30% (prothrombin time <20 s), moderate or mild ascites, spontaneous bacterial peritonitis and hepatic encephalopathy have been cured, Child-pugh score ≥7.
- Peripheral blood hemoglobin concentration> 70g/L，platelet count > 3 × 10^9/L, hematocrit (HCT) level>0.25.
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- No gastrointestinal bleeding during the last one month before enrolment.
- Patient has no conditional to undergo orthotopic liver transplantation (OLT).
- Willing to sign informed consent.
Who cannot join
- Participants CANNOT meet any of the following criteria:
- The presence of hepatocellular carcinoma (HCC) or other malignant tumors.
- Complicated with gastrointestinal bleeding, spontaneous bacterial peritonitis, hepatic encephalopathy, hepatorenal syndrome and acute exacerbation of infection.
- Presence of severe comorbid diseases (e.g., severe renal, respiratory, cardiac or blood disease).
- Pregnant or lactating women.
- Allergy to G-CSF, contrast agents and anticoagulants.
- Alcoholism or drug abuse.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Nanjing, Jiangsu, 210008
Xiaolei Shi, M.D., 86-25-83304616 ext. 11901, njsxl2000@163.com
About this study
Official title: The Safety and Efficacy Assessment of Injectable Collagen Scaffold™ Combined With Human Umbilical Cord-derived Mesenchymal Stem Cells (HUC-MSCs) Transplantation in Patients With Decompensated Cirrhosis
The purpose of this study is to assess the safety and efficacy of injectable collagen scaffold combined with human umbilical cord-derived mesenchymal stem cells (HUC-MSCs) transplantation in patients with Decompensated Cirrhosis.
- Conditions
- Decompensated Cirrhosis
- Being tested
- Conventional therapy, Injectable Collagen Scaffold + HUC-MSCs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional therapyBiological
Patients will receive the conventional therapy.
Injectable Collagen Scaffold + HUC-MSCsBiological
Injectable collagen scaffold combined with HUC-MSCs was injected into left lateral segment, left medial segment, right anterior segment, right posterior segment and caudate lobe under B-mode ultrasound supervision, respectively. The total amount of HUC-MSCs was 5*10^8.
| Study group | Role | What they receive |
|---|---|---|
| Conventional therapy | Sham comparator | Not described Receives: Biological: Conventional therapy |
| Injectable Collagen Scaffold + HUC-MSCs | Experimental | Not described Receives: Biological: Injectable Collagen Scaffold + HUC-MSCs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of liver function measured by change in the model for end-stage liver disease (MELD) score
Measured: 1 week, 2 week, 1, 3, 6, 12, 24 month after intervention
Secondary outcomes (4)
Improvement of liver function measured by change in Child-Pugh score
Measured: 1 week, 2 week, 1, 3, 6, 12, 24 month after intervention
Change in clinical laboratory parameters of liver function
The liver function tests included serum Albumin (Alb), Cholesterol, Cholinesterase (CHE), prothrombin activity.
Measured: 1 day, 3 day, 1 week, 2 week, 1, 3, 6, 12, 24 month after intervention
30-Day Survival
Patients surviving more than 30 days after study registration.
Measured: 30 days
Change in the size of liver and spleen and inner diameter of spleen portal venous
Measured: 1 week, 2 week, 1, 3, 6, 12, 24 month after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2016 (estimated)
- Study startMay 2016
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Decompensated 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese Academy of Sciences
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Jianwu Dai, Chinese Academy of Sciences
- Investigators
- Jianwu Dai, Ph.D, Principal investigator, Chinese Academy of Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02786017
- Sponsor's protocol ID
- CAS-XDA-DC/IGDB
- Status last verified
- Apr 2016
- First submitted
- 25 May 2016
- Last updated
- 13 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Efficacy Assessment of Injectable Collagen Scaffold™ Combined With Human Umbilical Cord-derived Mesenchymal Stem Cells (HUC-MSCs) Transplantation in Patients With Decompensated Cirrhosis
- ClinicalTrials.gov ID
- NCT02786017
- Acronym / sponsor ID
- CAS-XDA-DC/IGDB
- Conditions
- Decompensated Cirrhosis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Chinese Academy of SciencesOther government
- Collaborators
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Study start
- May 2016
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 30 May 2016 (estimated)
- 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 is to assess the safety and efficacy of injectable collagen scaffold combined with human umbilical cord-derived mesenchymal stem cells (HUC-MSCs) transplantation in patients with Decompensated Cirrhosis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional therapy | Sham comparator | Biological: Conventional therapy |
| Injectable Collagen Scaffold + HUC-MSCs | Experimental | Biological: Injectable Collagen Scaffold + HUC-MSCs |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Subjects who are decompensated cirrhosis of any cause.
- Subjects are repeated exacerbations despite treatment and hospitalized more than once within one year because of complications of cirrhosis, (e.g., massive ascites, spontaneous bacterial peritonitis, gastrointestinal bleeding or hepatic encephalopathy).
- Need intermittent plasma albumin and oral diuretics supplement.
- Serum albumin <35 g/L, total bilirubin<170 μmol/L, prothrombin activity >30% (prothrombin time <20 s), moderate or mild ascites, spontaneous bacterial peritonitis and hepatic encephalopathy have been cured, Child-pugh score ≥7.
- Peripheral blood hemoglobin concentration> 70g/L，platelet count > 3 × 10^9/L, hematocrit (HCT) level>0.25.
Key exclusion criteria (7 listed)
- The presence of hepatocellular carcinoma (HCC) or other malignant tumors.
- Complicated with gastrointestinal bleeding, spontaneous bacterial peritonitis, hepatic encephalopathy, hepatorenal syndrome and acute exacerbation of infection.
- Presence of severe comorbid diseases (e.g., severe renal, respiratory, cardiac or blood disease).
- Pregnant or lactating women.
- Allergy to G-CSF, contrast agents and anticoagulants.
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 therapyPatients will receive the conventional therapy. | Biological | Conventional therapy |
| Injectable Collagen Scaffold + HUC-MSCsInjectable collagen scaffold combined with HUC-MSCs was injected into left lateral segment, left medial segment, right anterior segment, right posterior segment and caudate lobe under B-mode ultrasound supervision, respectively. The total amount of HUC-MSCs was 5*10^8. | Biological | Injectable Collagen Scaffold + HUC-MSCs |
Primary outcome
Improvement of liver function measured by change in the model for end-stage liver disease (MELD) score
Time frame: 1 week, 2 week, 1, 3, 6, 12, 24 month after intervention
4 secondary outcomes
Improvement of liver function measured by change in Child-Pugh score
Time frame: 1 week, 2 week, 1, 3, 6, 12, 24 month after intervention
Change in clinical laboratory parameters of liver function
Time frame: 1 day, 3 day, 1 week, 2 week, 1, 3, 6, 12, 24 month after intervention
30-Day Survival
Time frame: 30 days
Change in the size of liver and spleen and inner diameter of spleen portal venous
Time frame: 1 week, 2 week, 1, 3, 6, 12, 24 month after intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2020.
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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.
Jianwu Dai, Ph.D principal investigator
Chinese Academy of Sciences
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 Conventional therapy and Injectable Collagen Scaffold + HUC-MSCs in people with Decompensated Cirrhosis, run by Chinese Academy of Sciences 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 9 inclusion and 7 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 13 Jan 2020. 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 Zhifeng Xiao, Ph.D (86-10-82614420, zfxiao@genetics.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of liver function measured by change in the model for end-stage liver disease (MELD) score (time frame: 1 week, 2 week, 1, 3, 6, 12, 24 month after intervention). 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 13 Jan 2020.