Hepatic CirrhosisPhase 1NCT02652351
Human Umbilical Cord-Mesenchymal Stem Cells for Hepatic Cirrhosis
A Phase 1 study testing Human umbilical cord mesenchymal stem cells in people with Hepatic Cirrhosis, run by Shenzhen Hornetcorn Bio-technology Company, LTD at 1 site in China.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of human umbilical cord mesenchymal stem cell(hUC-MSC) for Hepatic Cirrhosis. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hepatic Cirrhosis
- What is being tested?
- Human umbilical cord mesenchymal stem cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- Mar 2016to Oct 2016
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patient who have signed the informed consent document;
- Clinical, radiological, or biochemical evidence of liver cirrhosis.
Who cannot join
- Pregnant women or lactating mothers;
- Patients who have received any anti-inflammatory drugs including herb-drug within 14 days;
- Patients who received any drug by intra-articular injection for treatment within 2 months prior to this enrollment;
- Patients with positive human immunodeficiency (HIV) at screening indicative of current of pass infection;
- Abnormal blood coagulation, combine other tumor or special condition;
- Patients who had participated in other clinical trials within three months prior to this study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The second Affiliated Hospital of University of Soth China
Hengyang, Hunan, 431224
Gang Chen, Professor, 0734-8899939 ext. 621, Chengang@126.com
About this study
Official title: Safety and Efficacy Study of Human Umbilical Cord-Mesenchymal Stem Cells for Hepatic Cirrhosis
The purpose of this study is to evaluate the safety and efficacy of human umbilical cord mesenchymal stem cell(hUC-MSC) for Hepatic Cirrhosis.
Read the detailed description
Human umbilical cord mesenchymal stem cells exhibit the potential to differentiate into mature cells typical of several tissues, which have been confirmed in in vivo and in vitro experiments. There have been few clinical reports describing umbilical cord mesenchymal stem cells for treatment of Hepatic Cirrhosis.
To investigate the effects of hUC-MSC treatment for Hepatic Cirrhosis, 20 patients with Hepatic Cirrhosis will be enrolled and receive 4 times of hUC-MSC transplantation.
- Conditions
- Hepatic Cirrhosis
- Being tested
- Human umbilical cord mesenchymal stem cells
- Keywords
- Stem cell, Human Umbilical Cord Mesenchymal Stem Cell, Mesenchymal Stem Cell, Hepatic Cirrhosis
- Medical subject headings
- Liver Cirrhosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human umbilical cord mesenchymal stem cellsBiological
Also called hUC-MSC
A single dose of 2×107 hUC-MSC will be implanted to patients by intravenous infusion or Hepatic artery intervention, and repeated every week for four times.
| Study group | Role | What they receive |
|---|---|---|
| hUC-MSC treatment | Experimental | Patients will receive human umbilical cord mesenchymal stem cells transplantation with a 12 months follow-up. Receives: Biological: Human umbilical cord mesenchymal stem cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Severity of adverse events
According to National Cancer Institute Common Terminology Criteria for Adverse Events（NCI-CTCAE)
Measured: 12 months
Secondary outcomes (2)
Hepatic function
Include AST, ALT, T-Bil and A/G.
Measured: 1, 3 ,6 and 12 months
Liver fibrosis index
The level of Hyaluronidase,Laminin,Procollagen Ⅲ and Collagen Type IV in serum.
Measured: 1, 3 ,6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2016 (estimated)
- Study startMar 2016
- Primary completionMay 2016 (estimated)
- Study completionOct 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen Hornetcorn Bio-technology Company, LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The Second Hospital University of South China
- Responsible party
- Sponsor
- Investigators
- Gang Chen, Professor, Principal investigator, The second Affiliated Hospital of University of Soth China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02652351
- Sponsor's protocol ID
- HYK-hepatic cirrhosis
- Status last verified
- Jan 2016
- First submitted
- 7 Jan 2016
- Last updated
- 23 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy Study of Human Umbilical Cord-Mesenchymal Stem Cells for Hepatic Cirrhosis
- ClinicalTrials.gov ID
- NCT02652351
- Acronym / sponsor ID
- HYK-hepatic cirrhosis
- Conditions
- Hepatic Cirrhosis
- Keywords
- Stem cell, Human Umbilical Cord Mesenchymal Stem Cell, Mesenchymal Stem Cell, Hepatic Cirrhosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Shenzhen Hornetcorn Bio-technology Company, LTDIndustry (pharma, biotech, devices)
- Collaborators
- The Second Hospital University of South China
- Study start
- Mar 2016
- Primary completion
- May 2016 (estimated)
- Study completion
- Oct 2016 (estimated)
- First posted
- 11 Jan 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 evaluate the safety and efficacy of human umbilical cord mesenchymal stem cell(hUC-MSC) for Hepatic Cirrhosis.
Detailed description
Human umbilical cord mesenchymal stem cells exhibit the potential to differentiate into mature cells typical of several tissues, which have been confirmed in in vivo and in vitro experiments. There have been few clinical reports describing umbilical cord mesenchymal stem cells for treatment of Hepatic Cirrhosis.
To investigate the effects of hUC-MSC treatment for Hepatic Cirrhosis, 20 patients with Hepatic Cirrhosis will be enrolled and receive 4 times of hUC-MSC transplantation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| hUC-MSC treatment | Experimental | Biological: Human umbilical cord mesenchymal stem cellsPatients will receive human umbilical cord mesenchymal stem cells transplantation with a 12 months follow-up. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- The patient who have signed the informed consent document;
- Clinical, radiological, or biochemical evidence of liver cirrhosis.
Key exclusion criteria (6 listed)
- Pregnant women or lactating mothers;
- Patients who have received any anti-inflammatory drugs including herb-drug within 14 days;
- Patients who received any drug by intra-articular injection for treatment within 2 months prior to this enrollment;
- Patients with positive human immunodeficiency (HIV) at screening indicative of current of pass infection;
- Abnormal blood coagulation, combine other tumor or special condition;
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 |
|---|---|---|
| Human umbilical cord mesenchymal stem cellsAlso: hUC-MSCA single dose of 2×107 hUC-MSC will be implanted to patients by intravenous infusion or Hepatic artery intervention, and repeated every week for four times. | Biological | hUC-MSC treatment |
Primary outcome
Severity of adverse events
Time frame: 12 months
According to National Cancer Institute Common Terminology Criteria for Adverse Events（NCI-CTCAE)
2 secondary outcomes
Hepatic function
Time frame: 1, 3 ,6 and 12 months
Liver fibrosis index
Time frame: 1, 3 ,6 and 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2016.
- 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.
Gang Chen, Professor principal investigator
The second Affiliated Hospital of University of Soth China
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 Human umbilical cord mesenchymal stem cells in people with Hepatic Cirrhosis, run by Shenzhen Hornetcorn Bio-technology Company, 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 2 inclusion and 6 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 23 May 2016. 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 Jin S Cao, lab master (+86 0734-53137955, CaoJS@hornetcon.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Severity of adverse events (time frame: 12 months). 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 23 May 2016.