Liver CirrhosisPhase 2/3NCT01560845

ABMSC Infusion Through Hepatic Artery in Portal Hypertension Surgery for the Treatment of Liver Cirrhosis

A Phase 2/3 study testing Autologous bone marrow stem cells infusion （ABMSCi） plus abdominal portal hypertension surgery and open abdominal portal hypertension surgery in people with Liver Cirrhosis and Portal Hypertension, run by Wenzhou 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 The sponsor has not verified this record for over two years, so it may be out of date.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

In recent years, the safety and efficacy of autologous bone marrow stem cells infusion (ABMSCi) therapy were confirmed. The investigators attempted to infuse autologous bone marrow stem cells (ABMSC) through inserting a catheter into right gastric artery as far as proper hepatic artery after finishing open abdominal… Read more about this study

Who is it for?: Ages 18 to 60 years
Conditions the study is for: Liver Cirrhosis, Portal Hypertension, Hepatic Decompensation
What is being tested?: Autologous bone marrow stem cells infusion （ABMSCi） plus abdominal portal hypertension surgery and open abdominal portal hypertension surgery
Type of treatment: Injection or infusion, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 50 participants
Where: 1 siteChina
Study dates: Jun 2010to Jun 2014
Phase: Phase 2/3
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 60 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Advanced liver cirrhosis after hepatitis B resulted in bleeding from esophageal varices and hypersplenism, and needed open abdominal portal hypertension surgery;
Endoscopy evidence of showing severe gastric and esophageal varices;
Severe hypersplenism （white blood cells (WBC) <3×109/L and platelet (PLT) <100×109/L）;
Active bone marrow hyperplasia showed by bone marrow biopsy before surgery;
Age between 18 and 60 years;
Plasma albumin <35g/L, or mild ascites;

Who cannot join

Enlisted for liver transplantation
Diagnosis of hepatocellular carcinoma or other cancers
Other severe medical disease, and acute infection.

Trial locations and contacts

1 site in 1 country.

qiqiang zeng, MD contact

86-0577-88069307

zengqiqiangwz@163.com

China1 site, 1 recruiting

the First Affiliated Hospital of Wenzhou Medical College
Wenzhou, Zhejiang, 325000
qiqiang zeng, MD, 86-0577-88069307, zengqiqiangwz@163.com
qiqiang zeng, MD
Recruiting

Other trials in China

About this study

Official title: Autologous Bone Marrow Stem Cells Infusion Through Hepatic Artery in Open Abdominal Portal Hypertension Surgery for the Treatment of Liver Cirrhosis: a Prospective, Non-randomized, Controlled Study

Read the detailed description

ABMSC mobilization and harvest

For harvesting more ABMSC, ABMSC mobilization was induced by rhG-CSF (Gran○R), administered subcutaneously at a dose of 300μg daily for three consecutive days before open abdominal portal hypertension surgery.
Bone marrow (160-200ml) of the patients was harvested from both posterior superior iliac according to standard procedures under local anaesthesia and was collected in a plastic bag containing heparin.

Open abdominal portal hypertension surgery

Immediately after the harvest of ABMSC, the modified Sugiura procedure was performed for the patients who were assigned to the study group. The same surgical procedure was also performed for the control group (without harvest of ABMSC and ABMSC infusion).

ABMSC separation and infusion

While performing the portal hypertension surgery, ABMSC was separated and purified in a class 10,000 clean laboratory. After fat and bony particles were removed by filtration, collected cells were moved to a cell-processing device. We used the reagent kit ([Patent Number] ZL 2006 1 0106875.5; [Number of Criteria Applicable] YZB/NING YIN 0008-2008; [Researcher and Developer] Wealthlin Science \& Technology Inc., Canada; [Producer] Ningxia Zhonglianda Biotech Co., Ltd.). The reagents adopt the method of negative cells collection. Take the cells which intended to remove as target cells, and carry out the removal step-by-step. On the basis of this method, red blood cells, blood platelets, blood plasma will be completely removed with part of white cells and lymphocytes being remarkably removed as well while all the stem cells / progenitor cells are being well retained.
The nucleated cell (white blood cell) count of final ABMSC was measured by an automated complete blood count instrument and flow cytometry analysis. The number of mononuclear cells was counted manually under a microscope by Wright-Giemsa stain method. CD34 positive cells were determined by flow cytometry analysis.
The time of ABMSC separation and purification was 2.5-3 hours which had to be completed before the conclusion of portal hypertension surgery (3-3.5 hours). ABMSC was added to 10 ml saline and well mixed by shaking the vial gently. Before incision closure, the right gastric artery or right gastroepiploic artery was selected and a catheter was inserted. The catheter was pushed to reach the proper hepatic artery. The diameter of the catheter is 1.4mm, it is thin enough to easily been inserted to right gastric artery or right gastroepiploic artery (central venous catheterization, REF product NO.ES-04218, Arrow International, Inc.). The mixture of saline and AMBC was infused into hepatic artery at uniform speed for about two minutes. The catheter was removed after the ABMSCi. The puncture point of the right gastric artery was repaired using blood vessel suture or transfixed.

Statistical analysis - Categorical data are presented as absolute values and percentages, whereas continuous data are summarized as mean and Standard Deviation. Statistical analysis was performed using t-test for paired or unpaired samples. Time courses of measurements of liver function parameters were analyzed by repeated-measures ANOVA. The analyses were performed using the SPSS 15.0 statistical package (SPSS Inc., Chicago, IL, USA). All statistical analyses were based on two-tailed hypothesis tests with a significance level of p< 0.05.

Conditions: Liver Cirrhosis, Portal Hypertension, Hepatic Decompensation, Surgery
Being tested: Autologous bone marrow stem cells infusion （ABMSCi） plus abdominal portal hypertension surgery, open abdominal portal hypertension surgery
Keywords: autologous bone marrow stem cells, portal hypertension, surgery, liver cirrhosis
Medical subject headings: Liver Cirrhosis, Hypertension, Portal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Autologous bone marrow stem cells infusion （ABMSCi） plus abdominal portal hypertension surgeryProcedure or surgery
Immediately after the harvest of ABMSC, the modified Sugiura procedure was performed for the patients who were assigned to the study group. The time of ABMSC separation and purification was 2.5-3 hours which had to be completed before the conclusion of portal hypertension surgery (3-3.5 hours). ABMSC was infused into proper hepatic artery through right gastric artery during the portal hypertension surgery
open abdominal portal hypertension surgeryProcedure or surgery
the modified Sugiura procedure was performed for the patients

Study groups in NCT01560845
Study group	Role	What they receive
ABMSCi plus surgery group	Experimental	Autologous bone marrow stem cells infusion through hepatic artery in open abdominal portal hypertension surgery Receives: Procedure: Autologous bone marrow stem cells infusion （ABMSCi） plus abdominal portal hypertension surgery
portal hypertension surgery group	No intervention	only portal hypertension surgery for this group patients Receives: Procedure: open abdominal portal hypertension surgery

What is being measured

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

Child-pugh score
Measured: 1 month after treament

Secondary outcomes (6)

Incidence of complications
postoperative pyrexia, intraperitoneal hemorrhage, intraperitoneal infection, malignant tumors of liver and other systems
Measured: within the first week after treatment
Mortality
Measured: 1week, 1 month, 3 month, 6 month, 1 year and 2 year
blood test (hypersplenism)
PLT and WBC
Measured: whinin 7 days before treatment, 1 week,1,3, 6 and 12 months after treatment
liver volume calculated by CT
estimation of liver volume using CT
Measured: whinin 7 days before treatment, 1 month and a year after treatment
Indocyanine green (ICG) retention (clearance)
Measured: whinin 7 days before treatment, 1 week,1,3, 6 and 12 months after treatment
blood biochemistry
1. alanine aminotransferase
2. aspartate aminotransferase
3. total bilirubin
4. direct bilirubin
5. The total bile acid (TBA)
6. serum cholinesterase (CHE)
7. albumin
8. prothrombin time (PT)
9. international normalized ratio (INR)
Measured: whinin 7 days before treatment, 1 week,1,3, 6 and 12 months after treatment

Timeline

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

Jun 2010Jun 2014

First posted22 Mar 2012 (estimated)
Study startJun 2010
Primary completionJun 2013 (estimated)
Study completionJun 2014 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (4)Papers the sponsor has linked to this study.
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 2/3
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 50 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01560845
Sponsor's protocol ID: WZMC1-10-1
Status last verified: Mar 2012
First submitted: 18 Mar 2012
Last updated: 22 Mar 2012
Results posted: No
Data monitoring committee: No

Publications

am Esch JS, Schmelzle M, Furst G, Robson SC, Krieg A, Duhme C, Tustas RY, Alexander A, Klein HM, Topp SA, Bode JG, Haussinger D, Eisenberger CF, Knoefel WT. Infusion of CD133+ bone marrow-derived stem cells after selective portal vein embolization enhances functional hepatic reserves after extended right hepatectomy: a retrospective single-center study. Ann Surg. 2012 Jan;255(1):79-85. doi: 10.1097/SLA.0b013e31823d7d08.
PubMed 22156926
Kim JK, Park YN, Kim JS, Park MS, Paik YH, Seok JY, Chung YE, Kim HO, Kim KS, Ahn SH, Kim DY, Kim MJ, Lee KS, Chon CY, Kim SJ, Terai S, Sakaida I, Han KH. Autologous bone marrow infusion activates the progenitor cell compartment in patients with advanced liver cirrhosis. Cell Transplant. 2010;19(10):1237-46. doi: 10.3727/096368910X506863. Epub 2010 Jun 3.
PubMed 20525430
Peng L, Xie DY, Lin BL, Liu J, Zhu HP, Xie C, Zheng YB, Gao ZL. Autologous bone marrow mesenchymal stem cell transplantation in liver failure patients caused by hepatitis B: short-term and long-term outcomes. Hepatology. 2011 Sep 2;54(3):820-8. doi: 10.1002/hep.24434. Epub 2011 Jul 14.
PubMed 21608000
Terai S, Ishikawa T, Omori K, Aoyama K, Marumoto Y, Urata Y, Yokoyama Y, Uchida K, Yamasaki T, Fujii Y, Okita K, Sakaida I. Improved liver function in patients with liver cirrhosis after autologous bone marrow cell infusion therapy. Stem Cells. 2006 Oct;24(10):2292-8. doi: 10.1634/stemcells.2005-0542. Epub 2006 Jun 15.
PubMed 16778155

Want to know more?

qiqiang zeng, MD

86-0577-88069307

zengqiqiangwz@163.com

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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Study at a glance

From the registry record, last updated by the sponsor on 22 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Autologous Bone Marrow Stem Cells Infusion Through Hepatic Artery in Open Abdominal Portal Hypertension Surgery for the Treatment of Liver Cirrhosis: a Prospective, Non-randomized, Controlled Study
ClinicalTrials.gov ID: NCT01560845
Acronym / sponsor ID: WZMC1-10-1
Conditions: Liver Cirrhosis, Portal Hypertension, Hepatic Decompensation, Surgery
Keywords: autologous bone marrow stem cells, portal hypertension, surgery, liver cirrhosis
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 50 participants (estimated)
Lead sponsor: Wenzhou Medical UniversityUniversity, hospital or other
Study start: Jun 2010
Primary completion: Jun 2013 (estimated)
Study completion: Jun 2014 (estimated)
First posted: 22 Mar 2012 (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.

Detailed description

ABMSC mobilization and harvest

For harvesting more ABMSC, ABMSC mobilization was induced by rhG-CSF (Gran○R), administered subcutaneously at a dose of 300μg daily for three consecutive days before open abdominal portal hypertension surgery.
Bone marrow (160-200ml) of the patients was harvested from both posterior superior iliac according to standard procedures under local anaesthesia and was collected in a plastic bag containing heparin.

Open abdominal portal hypertension surgery

Immediately after the harvest of ABMSC, the modified Sugiura procedure was performed for the patients who were assigned to the study group. The same surgical procedure was also performed for the control group (without harvest of ABMSC and ABMSC infusion).

ABMSC separation and infusion

While performing the portal hypertension surgery, ABMSC was separated and purified in a class 10,000 clean laboratory. After fat and bony particles were removed by filtration, collected cells were moved to a cell-processing device. We used the reagent kit ([Patent Number] ZL 2006 1 0106875.5; [Number of Criteria Applicable] YZB/NING YIN 0008-2008; [Researcher and Developer] Wealthlin Science \& Technology Inc., Canada; [Producer] Ningxia Zhonglianda Biotech Co., Ltd.). The reagents adopt the method of negative cells collection. Take the cells which intended to remove as target cells, and carry out the removal step-by-step. On the basis of this method, red blood cells, blood platelets, blood plasma will be completely removed with part of white cells and lymphocytes being remarkably removed as well while all the stem cells / progenitor cells are being well retained.
The nucleated cell (white blood cell) count of final ABMSC was measured by an automated complete blood count instrument and flow cytometry analysis. The number of mononuclear cells was counted manually under a microscope by Wright-Giemsa stain method. CD34 positive cells were determined by flow cytometry analysis.
The time of ABMSC separation and purification was 2.5-3 hours which had to be completed before the conclusion of portal hypertension surgery (3-3.5 hours). ABMSC was added to 10 ml saline and well mixed by shaking the vial gently. Before incision closure, the right gastric artery or right gastroepiploic artery was selected and a catheter was inserted. The catheter was pushed to reach the proper hepatic artery. The diameter of the catheter is 1.4mm, it is thin enough to easily been inserted to right gastric artery or right gastroepiploic artery (central venous catheterization, REF product NO.ES-04218, Arrow International, Inc.). The mixture of saline and AMBC was infused into hepatic artery at uniform speed for about two minutes. The catheter was removed after the ABMSCi. The puncture point of the right gastric artery was repaired using blood vessel suture or transfixed.

Statistical analysis - Categorical data are presented as absolute values and percentages, whereas continuous data are summarized as mean and Standard Deviation. Statistical analysis was performed using t-test for paired or unpaired samples. Time courses of measurements of liver function parameters were analyzed by repeated-measures ANOVA. The analyses were performed using the SPSS 15.0 statistical package (SPSS Inc., Chicago, IL, USA). All statistical analyses were based on two-tailed hypothesis tests with a significance level of p< 0.05.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
ABMSCi plus surgery group	Experimental	Procedure: Autologous bone marrow stem cells infusion （ABMSCi） plus abdominal portal hypertension surgeryAutologous bone marrow stem cells infusion through hepatic artery in open abdominal portal hypertension surgery
portal hypertension surgery group	No intervention	Procedure: open abdominal portal hypertension surgeryonly portal hypertension surgery for this group patients

Who may qualify

Ages: 18 to 60 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (6 listed)

Advanced liver cirrhosis after hepatitis B resulted in bleeding from esophageal varices and hypersplenism, and needed open abdominal portal hypertension surgery;
Endoscopy evidence of showing severe gastric and esophageal varices;
Severe hypersplenism （white blood cells (WBC) <3×109/L and platelet (PLT) <100×109/L）;
Active bone marrow hyperplasia showed by bone marrow biopsy before surgery;
Age between 18 and 60 years;

Key exclusion criteria (3 listed)

Enlisted for liver transplantation
Diagnosis of hepatocellular carcinoma or other cancers
Other severe medical disease, and acute infection.

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
Autologous bone marrow stem cells infusion （ABMSCi） plus abdominal portal hypertension surgeryImmediately after the harvest of ABMSC, the modified Sugiura procedure was performed for the patients who were assigned to the study group. The time of ABMSC separation and purification was 2.5-3 hours which had to be completed before the conclusion of portal hypertension surgery (3-3.5 hours). ABMSC was infused into proper hepatic artery through right gastric artery during the portal hypertension surgery	Procedure or surgery	ABMSCi plus surgery group
open abdominal portal hypertension surgerythe modified Sugiura procedure was performed for the patients	Procedure or surgery	portal hypertension surgery group

Primary outcome

Child-pugh score
Time frame: 1 month after treament

6 secondary outcomes

Incidence of complications
Time frame: within the first week after treatment
Mortality
Time frame: 1week, 1 month, 3 month, 6 month, 1 year and 2 year
blood test (hypersplenism)
Time frame: whinin 7 days before treatment, 1 week,1,3, 6 and 12 months after treatment
liver volume calculated by CT
Time frame: whinin 7 days before treatment, 1 month and a year after treatment
Indocyanine green (ICG) retention (clearance)
Time frame: whinin 7 days before treatment, 1 week,1,3, 6 and 12 months after treatment
blood biochemistry
Time frame: whinin 7 days before treatment, 1 week,1,3, 6 and 12 months after treatment

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2012.
Background: PubMed 22156926am Esch JS, Schmelzle M, Furst G, Robson SC, Krieg A, Duhme C, Tustas RY, Alexander A, Klein HM, Topp SA, Bode JG, Haussinger D, Eisenberger CF, Knoefel WT. Infusion of CD133+ bone marrow-derived stem cells after selective portal vein embolization enhances functional hepatic reserves after extended right hepatectomy: a retrospective single-center study. Ann Surg. 2012 Jan;255(1):79-85. doi: 10.1097/SLA.0b013e31823d7d08.
Background: PubMed 20525430Kim JK, Park YN, Kim JS, Park MS, Paik YH, Seok JY, Chung YE, Kim HO, Kim KS, Ahn SH, Kim DY, Kim MJ, Lee KS, Chon CY, Kim SJ, Terai S, Sakaida I, Han KH. Autologous bone marrow infusion activates the progenitor cell compartment in patients with advanced liver cirrhosis. Cell Transplant. 2010;19(10):1237-46. doi: 10.3727/096368910X506863. Epub 2010 Jun 3.
Background: PubMed 21608000Peng L, Xie DY, Lin BL, Liu J, Zhu HP, Xie C, Zheng YB, Gao ZL. Autologous bone marrow mesenchymal stem cell transplantation in liver failure patients caused by hepatitis B: short-term and long-term outcomes. Hepatology. 2011 Sep 2;54(3):820-8. doi: 10.1002/hep.24434. Epub 2011 Jul 14.
Background: PubMed 16778155Terai S, Ishikawa T, Omori K, Aoyama K, Marumoto Y, Urata Y, Yokoyama Y, Uchida K, Yamasaki T, Fujii Y, Okita K, Sakaida I. Improved liver function in patients with liver cirrhosis after autologous bone marrow cell infusion therapy. Stem Cells. 2006 Oct;24(10):2292-8. doi: 10.1634/stemcells.2005-0542. Epub 2006 Jun 15.

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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.

qiqiang zeng, MD contact

86-0577-88069307

zengqiqiangwz@163.com

qiyu zhang, MD study chair

First Affiliated Hospital of Wenzhou Medical University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 6 inclusion and 3 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 22 Mar 2012. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 qiqiang zeng, MD (86-0577-88069307, zengqiqiangwz@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Child-pugh score (time frame: 1 month after treament). 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 NCT01560845, which also lists 4 linked publications.

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 22 Mar 2012.