Liver CirrhosisPhase 1NCT01942915

Umbilical Cord Blood Mononuclear Cells Therapy in Liver Cirrhosis

A Phase 1 study testing Umbilical Cord Blood Mononuclear Cells in people with Liver Cirrhosis, run by Hebei Medical University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

This study is to evaluate the safety and efficacy of umbilical cord blood mononuclear cells transplantation in liver cirrhosis patients. Read more about this study

Who is it for?: Ages 20 to 80 years
Conditions the study is for: Liver Cirrhosis
What is being tested?: Umbilical Cord Blood Mononuclear Cells
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 10 participants
Where: 1 siteChina
Study dates: Jan 2012to Dec 2014
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 20 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients with hepatocirrhosis: according to the standard of child- pugh, liver functions to achieve class A or B patients, Including C class patients but can achieve B class after treatment

Who cannot join

Patients with C class by child-pugh score
Patients in the acute phase of severe hepatitis
Patients have been diagnosed with cancer of the liver
Patients with severe cardiopulmonary cerebral disease, and in the failure state
Patients in Highly allergic constitution
Patients with moderately severe mental disease

Trial locations and contacts

1 site in 1 country.

China1 site

the First Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050000

Other trials in China

About this study

Official title: Safety and Efficacy Investigation of Patients With Liver Cirrhosis by Transplantation of Umbilical Cord Blood Mononuclear Cells

This study is to evaluate the safety and efficacy of umbilical cord blood mononuclear cells transplantation in liver cirrhosis patients.

Read the detailed description

Decompensated liver cirrhosis (LC), a life-threatening complication of chronic liver disease, is one of the major indications for liver transplantation. Recently, umbilical cord blood mononuclear cells transfusion has been shown to lead to the regression of liver fibrosis in animal model. The investigators thus investigated the safety of the therapy with life signs like temperature, pulse, blood pressure, the incidence of hepatocellular carcinoma and mortality and so on. And the efficacy was evaluated with the measurement of alanine aminotransferase (ALT), glutamic oxaloacetic transaminase (AST), total bilirubin (TBIL), direct bilirubin (DBIL), albumin (ALB), cholinesterase (CHE), prothrombin time (PT) and child-pugh score.

Conditions: Liver Cirrhosis
Being tested: Umbilical Cord Blood Mononuclear Cells
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 Blood Mononuclear CellsBiological
Participants will be transplanted with umbilical cord blood mononuclear cells.

Study groups in NCT01942915
Study group	Role	What they receive
umbilical cord blood mononuclear cells	Experimental	Umbilical Cord blood come from healthy puerpera. Erythrocyte in umbilical cord blood was separated and deleted through sedimentation. Mononuclear cells in umbilical cord blood were then isolated with a conventional method and reagent,Ficoll,by density gradient centrifugation. Receives: Biological: Umbilical Cord Blood Mononuclear Cells

What is being measured

The primary outcome is the main question the study is designed to answer.

child-pugh classification
1. child-pugh A (child-pugh score 5-6)
2. child-pugh B (child-pugh score 7-9)
3. child-pugh C (child-pugh score≥10)
Measured: whinin 7 days before transplantation, 1,3 and 6 months after transplantation

Secondary outcomes (5)

coagulation
1. prothrombin time (PT)
2. activated partial thromboplastin time (APTT)
3. fibrinogen (FIB)
Measured: whinin 7 days before transplantation, 1,3,6 months after transplantation
liver function
1. alanine aminotransferase (ALT)
2. aspartate aminotransferase (AST)
3. total bilirubin （TBIL）
4. direct bilirubin (DBIL)
5. serum cholinesterase (CHE)
6. albumin (ALB)
Measured: whinin 7 days before transplantation, 1,3 and 6 months after transplantation
vital signs
1. temperature
2. pulse
3. blood pressure
Measured: 1, 2 and 3 days after transplantation
incidence of hepatocellular carcinoma
Measured: 1, 3 and 6 months after transplantation
mortality
Measured: 1, 3 and 6 months after transplantation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2012Dec 2014

First posted16 Sep 2013 (estimated)
Study startJan 2012
Primary completionDec 2013 (estimated)
Study completionDec 2014 (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
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 10 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01942915
Sponsor's protocol ID: 12276102D-Liver Cirrhosis
Status last verified: Nov 2013
First submitted: 6 Sep 2013
Last updated: 15 Nov 2013
Results posted: No
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Effectiveness and Clinical Outcomes of Long-term Bulevirtide Monotherapy in Patients With HDV-related Compensated Cirrhosis
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The Value of Spleen Thickness and Spleen Diameter for Gastroesophageal Varices Diagnosis in Compensated Cirrhosis
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Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
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All Liver Cirrhosis trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety and Efficacy Investigation of Patients With Liver Cirrhosis by Transplantation of Umbilical Cord Blood Mononuclear Cells
ClinicalTrials.gov ID: NCT01942915
Acronym / sponsor ID: 12276102D-Liver Cirrhosis
Conditions: Liver Cirrhosis
Phase: Phase 1
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 10 participants (estimated)
Lead sponsor: Hebei Medical UniversityUniversity, hospital or other
Study start: Jan 2012
Primary completion: Dec 2013 (estimated)
Study completion: Dec 2014 (estimated)
First posted: 16 Sep 2013 (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.

This study is to evaluate the safety and efficacy of umbilical cord blood mononuclear cells transplantation in liver cirrhosis patients.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
umbilical cord blood mononuclear cells	Experimental	Biological: Umbilical Cord Blood Mononuclear CellsUmbilical Cord blood come from healthy puerpera. Erythrocyte in umbilical cord blood was separated and deleted through sedimentation. Mononuclear cells in umbilical cord blood were then isolated with a conventional method and reagent,Ficoll,by density gradient centrifugation.

Who may qualify

Ages: 20 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Patients with hepatocirrhosis: according to the standard of child- pugh, liver functions to achieve class A or B patients, Including C class patients but can achieve B class after treatment

Key exclusion criteria (6 listed)

Patients with C class by child-pugh score
Patients in the acute phase of severe hepatitis
Patients have been diagnosed with cancer of the liver
Patients with severe cardiopulmonary cerebral disease, and in the failure state
Patients in Highly allergic constitution

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 Blood Mononuclear CellsParticipants will be transplanted with umbilical cord blood mononuclear cells.	Biological	umbilical cord blood mononuclear cells

Primary outcome

child-pugh classification
Time frame: whinin 7 days before transplantation, 1,3 and 6 months after transplantation
1. child-pugh A (child-pugh score 5-6) 2. child-pugh B (child-pugh score 7-9) 3. child-pugh C (child-pugh score≥10)

5 secondary outcomes

coagulation
Time frame: whinin 7 days before transplantation, 1,3,6 months after transplantation
liver function
Time frame: whinin 7 days before transplantation, 1,3 and 6 months after transplantation
vital signs
Time frame: 1, 2 and 3 days after transplantation
incidence of hepatocellular carcinoma
Time frame: 1, 3 and 6 months after transplantation
mortality
Time frame: 1, 3 and 6 months after transplantation

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2013.

Related trials for Liver Cirrhosis

RecruitingObservational study
Effectiveness and Clinical Outcomes of Long-term Bulevirtide Monotherapy in Patients With HDV-related Compensated Cirrhosis
Hepatitis D
Recruiting
Optimal Treatment Strategy for Spontaneous Bacterial Peritonitis
Spontaneous Bacterial Peritonitis, Paracentesis
RecruitingObservational study
The Value of Spleen Thickness and Spleen Diameter for Gastroesophageal Varices Diagnosis in Compensated Cirrhosis
Liver Cirrhosis, Gastroesophageal Varices
Recruiting
CirrhosisRx CDS System
Cirrhosis, Decision Support Systems, Clinical
RecruitingPhase 3
Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Metabolic Dysfunction-Associated Steatotic Liver Disease, MASLD

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.

Baoyong Yan, doctor study chair

The First Hospital of Hebei Medical University

Lixin Tong, master study director

The First Hospital of Hebei Medical University

Sui Zhang, master principal investigator

The First Hospital of Hebei Medical 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 study testing Umbilical Cord Blood Mononuclear Cells in people with Liver Cirrhosis, run by Hebei Medical 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 1 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 15 Nov 2013. 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

child-pugh classification (time frame: whinin 7 days before transplantation, 1,3 and 6 months after transplantation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01942915.

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 15 Nov 2013.