Liver CirrhosisPhase 1/2NCT01224327
Umbilical Cord Mesenchymal Stem Cells Infusion Via Hepatic Artery in Cirrhosis Patients
A Phase 1/2 study testing umbilical cord Mesenchymal Stem Cells and Conserved therapy in people with Liver Cirrhosis and Radiology, run by Qingdao University at 1 site in China.
Trial summary
The purpose of this study is to investigate the efficacy of umbilical cord mesenchymal stem cells (MSCs) infusion via hepatic artery in the treatment of liver cirrhosis. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Liver Cirrhosis, Radiology, Mesenchymal Stem Cells
- What is being tested?
- umbilical cord Mesenchymal Stem Cells and Conserved therapy
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- Oct 2010to Dec 2012
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18~70 years.
- Liver cirrhosis
- written consent
Who cannot join
- The end-stage of liver cirrhosis.
- Severe problems in other vital organs(e.g.the heart,renal or lungs).
- Hepatocellular carcinoma or other malignancies
- Pregnancy
- sepsis
- Presence of significant extrahepatic biliary disease (e.g. CBD stone, PSC, etc.)
- Cardiac, renal or respiratory failure
- Active thrombosis of the portal or hepatic veins
Trial locations and contacts
1 site in 1 country.
China1 site
Stem Cell Research Center of Medical School Hospital of Qingdao University
Qingdao, Shandong, 266003
Jianxia Hu, MD, 86-0532-82911676, qdyxyhjx@126.com
Hong Gao, MS, 86-0532-82911676, honggaogloria@gmail.com
About this study
Official title: The Safety and Efficacy of Umbilical Cord Mesenchymal Stem Cells Infusion Via Hepatic Artery in Cirrhosis Patients.
The purpose of this study is to investigate the efficacy of umbilical cord mesenchymal stem cells (MSCs) infusion via hepatic artery in the treatment of liver cirrhosis.
Read the detailed description
To investigate the efficacy of umbilical cord mesenchymal stem cells (MSCs) infusion via hepatic artery in the treatment of liver cirrhosis. Patients with liver cirrhosis were randomly separated into two groups. Umbilical cord MSCs were infused to patients using interventional method via hepatic artery for One group. After the catheter placed at proper hepatic artery was confirmed by angiography, umbilical cord MSCs were infused slowly for 15-20minutes. The control group accepted conserved therapy.
- Conditions
- Liver Cirrhosis, Radiology, Mesenchymal Stem Cells, Umbilical Cord
- Being tested
- umbilical cord Mesenchymal Stem Cells, Conserved therapy
- Keywords
- Liver cirrhosis, Radiology, Mesenchymal Stem Cells, Umbilical Cord
- Medical subject headings
- Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
umbilical cord Mesenchymal Stem CellsBiological
Also called Mesenchymal Stem Cells
Umbilical cord mesenchymal stem cells were infused to patients using interventional method via hepatic artery. After the catheter placed at proper hepatic artery was confirmed by angiography,umbilical cord MSCs were infused slowly for 15-20minutes.
Conserved therapyDrug
Also called Drug therapy
Oral or intravenous administration
| Study group | Role | What they receive |
|---|---|---|
| umbilical cord mesenchymal stem cells | Experimental | Umbilical cord mesenchymal stem cells were infused to patients using interventional method via hepatic artery. After the catheter placed at proper hepatic artery was confirmed by angiography,umbilical cord MSCs were infused slowly for 15-20minutes. Receives: Biological: umbilical cord Mesenchymal Stem Cells |
| Conserved therapy | Active comparator | Patients received comprehensive treatment including antiviral drugs, lowering aminotransferase and jaundice medicine. Receives: Drug: Conserved therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
The result of liver function and liver histological improvement.
Measured: every 4 weeks
Secondary outcomes (2)
The disappearance or reduction of abdominal dropsy
Measured: every 4 weeks
The clinical symptom improve(including food appetite,debilitation,abdominal distension,edema of lower limbs )
Measured: every 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2010 (estimated)
- Study startOct 2010
- Primary completionOct 2012 (estimated)
- Study completionDec 2012 (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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qingdao University
- Sponsor type
- University, hospital or other
- Investigators
- Zibin Tian, MD, Study director, The Affiliated Hospital of Qingdao University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01224327
- Sponsor's protocol ID
- MSCHC005
- Status last verified
- Sep 2010
- First submitted
- 18 Oct 2010
- Last updated
- 20 Oct 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Safety and Efficacy of Umbilical Cord Mesenchymal Stem Cells Infusion Via Hepatic Artery in Cirrhosis Patients.
- ClinicalTrials.gov ID
- NCT01224327
- Acronym / sponsor ID
- MSCHC005
- Conditions
- Liver Cirrhosis, Radiology, Mesenchymal Stem Cells, Umbilical Cord
- Keywords
- Liver cirrhosis, Radiology, Mesenchymal Stem Cells, Umbilical Cord
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Qingdao UniversityUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Oct 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 20 Oct 2010 (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 investigate the efficacy of umbilical cord mesenchymal stem cells (MSCs) infusion via hepatic artery in the treatment of liver cirrhosis.
Detailed description
To investigate the efficacy of umbilical cord mesenchymal stem cells (MSCs) infusion via hepatic artery in the treatment of liver cirrhosis. Patients with liver cirrhosis were randomly separated into two groups. Umbilical cord MSCs were infused to patients using interventional method via hepatic artery for One group. After the catheter placed at proper hepatic artery was confirmed by angiography, umbilical cord MSCs were infused slowly for 15-20minutes. The control group accepted conserved therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| umbilical cord mesenchymal stem cells | Experimental | Biological: umbilical cord Mesenchymal Stem CellsUmbilical cord mesenchymal stem cells were infused to patients using interventional method via hepatic artery. After the catheter placed at proper hepatic artery was confirmed by angiography,umbilical cord MSCs were infused slowly for 15-20minutes. |
| Conserved therapy | Active comparator | Drug: Conserved therapyPatients received comprehensive treatment including antiviral drugs, lowering aminotransferase and jaundice medicine. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged 18~70 years.
- Liver cirrhosis
- written consent
Key exclusion criteria (8 listed)
- The end-stage of liver cirrhosis.
- Severe problems in other vital organs(e.g.the heart,renal or lungs).
- Hepatocellular carcinoma or other malignancies
- Pregnancy
- sepsis
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 |
|---|---|---|
| umbilical cord Mesenchymal Stem CellsAlso: Mesenchymal Stem CellsUmbilical cord mesenchymal stem cells were infused to patients using interventional method via hepatic artery. After the catheter placed at proper hepatic artery was confirmed by angiography,umbilical cord MSCs were infused slowly for 15-20minutes. | Biological | umbilical cord mesenchymal stem cells |
| Conserved therapyAlso: Drug therapyOral or intravenous administration | Drug | Conserved therapy |
Primary outcome
The result of liver function and liver histological improvement.
Time frame: every 4 weeks
2 secondary outcomes
The disappearance or reduction of abdominal dropsy
Time frame: every 4 weeks
The clinical symptom improve(including food appetite,debilitation,abdominal distension,edema of lower limbs )
Time frame: every 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2010.
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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.
Zibin Tian, MD study director
The Affiliated Hospital of Qingdao 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 umbilical cord Mesenchymal Stem Cells and Conserved therapy in people with Liver Cirrhosis and Radiology, run by Qingdao 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 3 inclusion and 8 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 20 Oct 2010. 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 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 Jianxia Hu, MD (86-0532-82911676, qdyxyhjx@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The result of liver function and liver histological improvement. (time frame: every 4 weeks). 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 20 Oct 2010.