Liver DiseasesPhase 2ABMSCIFTLDNCT02943707
Autologous Bone Marrow Stem Cells Infusion for the Treatment of Liver Diseases.
A Phase 2 study testing Autologous bone marrow stem cells infusion and drugs such as Ursodeoxycholic Acid tablets in people with Liver Diseases, run by Wenzhou Medical University at 1 site in China.
Trial summary
This study evaluates the effect of autologous bone marrow stem cells infusion (ABMSCi) therapy for liver diseases.Treatment group will receive ABMSCi and drugs therapy ,while control group will only receive drugs therapy. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Liver Diseases
- What is being tested?
- Autologous bone marrow stem cells infusion and drugs such as Ursodeoxycholic Acid tablets
- Type of treatment
- Pill or oral medicine, Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- Oct 2016to Oct 2020
- Phase
- Phase 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Definite liver diseases (such as viral hepatitis, autoimmune liver diseases, fatty liver diseases, ect);
- Active bone marrow hyperplasia showed by bone marrow biopsy before ABMSCi;
- Age between 18 and 60 years;
- Abnormal liver function.
Who cannot join
- Enlisted for liver transplantation
- Diagnosis of hepatocellular carcinoma or other cancers
- Other severe medical disease, and acute infection
- pregnant or nursing females,co-infections with HIV ,serious bacterial infection
- other vital organ or system dysfunction
- with severe complications of liver cirrhosis
- hematological disorder
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
the First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000
yongping chen, 8613505777281, 13505777281@163.com
lanman xu, 8613587646315, 13587646315@163.com
About this study
This study evaluates the effect of autologous bone marrow stem cells infusion (ABMSCi) therapy for liver diseases.Treatment group will receive ABMSCi and drugs therapy ,while control group will only receive drugs therapy.
Read the detailed description
- Autologous bone marrow stem cells (ABMSC) mobilization and harvest For harvesting more ABMSC, ABMSC mobilization is induced by recombinant human granulocyte colony stimulating factor (rhGCSF,Gran○R), administered subcutaneously at a dose of 300μg daily for three consecutive days before bone marrow puncture. Bone marrow (160-200ml) of the patients is harvested from both posterior superior iliacs according to standard procedures under local anaesthesia and is collected in a plastic bag containing heparin.
- Both treatment group and control group receive drugs therapy.
- ABMSC separation and infusion ABMSC is separated and purified in a class 10,000 clean laboratory. After fat and bony particles are removed by filtration, collected cells are moved to a cell-processing device. 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 is measured by an automated complete blood count instrument and flow cytometry analysis. The number of mononuclear cells is counted manually under a microscope by Wright-Giemsa stain method. Cell differentiation factor 34(CD34) positive cells were determined by flow cytometry analysis. The time of ABMSC separation and purification is 2.5-3 hours. ABMSC is added to 10 ml saline and well mixed by shaking the vial gently. The catheter is 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 . The mixture of saline and ABMSC is infused into proper hepatic artery at uniform speed for about two minutes. The catheter is removed after the ABMSCi.
- 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 analysis is performed using the Statistic Package for Social Science (SPSS). All statistical analysis is based on two-tailed hypothesis tests with a significance level of p< 0.05.
- Conditions
- Liver Diseases
- Being tested
- Autologous bone marrow stem cells infusion, drugs such as Ursodeoxycholic Acid tablets
- Keywords
- liver diseases, Bone Marrow Cell Transplantation
- Medical subject headings
- Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous bone marrow stem cells infusionProcedure or surgery
Also called ABMSCi
Autologous bone marrow stem cells are infused into proper hepatic artery
drugs such as Ursodeoxycholic Acid tabletsDrug
Also called UDCA
Ursodeoxycholic Acid tablets(UDCA), each time 150 mg, three times a day orally
| Study group | Role | What they receive |
|---|---|---|
| treatment group: ABMSCi & drugs | Experimental | ABMSCi: Autologous bone marrow stem cells infusion drugs such as Ursodeoxycholic Acid tablets(UDCA), each time 150 mg, three times a day orally Receives: Procedure: Autologous bone marrow stem cells infusion; Drug: drugs such as Ursodeoxycholic Acid tablets |
| control group: drugs | Active comparator | drugs such as Ursodeoxycholic Acid tablets(UDCA), each time 150 mg, three times a day orally Receives: Drug: drugs such as Ursodeoxycholic Acid tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline alanine aminotransferase at 6 months
alanine aminotransferase (ALT)
Measured: baseline and 6 months after treatment
Change from baseline aspartate aminotransferase at 6 months
aspartate aminotransferase (AST)
Measured: baseline and 6 months after treatment
Change from baseline total bilirubin at 6 months
total bilirubin (TBil)
Measured: baseline and 6 months after treatment
Change from baseline direct bilirubin at 6 months
direct bilirubin (DBil)
Measured: baseline and 6 months after treatment
Change from baseline total bile acid at 6 months
total bile acid (TBA)
Measured: baseline and 6 months after treatment
Change from baseline albumin at 6 months
albumin (ALB)
Measured: baseline and 6 months after treatment
Change from baseline prothrombin time at 6 months
prothrombin time (PT),
Measured: baseline and 6 months after treatment
Change from baseline international normalized ratio at 6 months
international normalized ratio (INR)
Measured: baseline and 6 months after treatment
Change from baseline white blood cell at 6 months
white blood cell (WBC)
Measured: baseline and 6 months after treatment
Change from baseline platelet at 6 months
platelet (PLT)
Measured: baseline and 6 months after treatment
Secondary outcomes (7)
Change from baseline liver density at 6 months
Low density, medium density, high density tested by abdominal B ultrasound/CT/MRI
Measured: baseline and 6 months after treatment
Change from baseline liver size at 6 months
Enlarged size, normal size, shrunken size tested by abdominal B ultrasound/CT/MRI
Measured: baseline and 6 months after treatment
Change from baseline spleen thickness at 6 months
tested by abdominal B ultrasound/CT/MRI
Measured: baseline and 6 months after treatment
Incidence of adverse events that are related to treatment
Postoperative pyrexia, infection, liver cirrhosis, ascites, upper gastrointestinal hemorrhage, malignant tumors of liver and other organs
Measured: baseline and 6 months after treatment
Number of participants that survive without developing disease
Measured: 12 months after treatment
Number of participants that survive with developing disease
Measured: 12 months after treatment
Number of participants that die after treatment
Measured: 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.
- First posted25 Oct 2016 (estimated)
- Study startOct 2016
- Primary completionOct 2017 (estimated)
- Study completionOct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Liver DiseasesStudies 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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wenzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, yongping chen, Wenzhou Medical University
- Investigators
- yongping chen, Study chair, First Affiliated Hospital of Wenzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02943707
- Sponsor's protocol ID
- 12330000470005914R
- Acronym
- ABMSCIFTLD
- Status last verified
- Oct 2016
- First submitted
- 17 Oct 2016
- Last updated
- 25 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Ma XR, Tang YL, Xuan M, Chang Z, Wang XY, Liang XH. Transplantation of autologous mesenchymal stem cells for end-stage liver cirrhosis: a meta-analysis based on seven controlled trials. Gastroenterol Res Pract. 2015;2015:908275. doi: 10.1155/2015/908275. Epub 2015 Mar 15.
PubMed 25861263Xu L, Gong Y, Wang B, Shi K, Hou Y, Wang L, Lin Z, Han Y, Lu L, Chen D, Lin X, Zeng Q, Feng W, Chen Y. Randomized trial of autologous bone marrow mesenchymal stem cells transplantation for hepatitis B virus cirrhosis: regulation of Treg/Th17 cells. J Gastroenterol Hepatol. 2014 Aug;29(8):1620-8. doi: 10.1111/jgh.12653.
PubMed 24942592Peng 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 21608000Deng Q, Cai T, Zhang S, Hu A, Zhang X, Wang Y, Huang J. Autologous Peripheral Blood Stem Cell Transplantation Improves Portal Hemodynamics in Patients with Hepatitis B Virus-related Decompensated Cirrhosis. Hepat Mon. 2015 Dec 20;15(12):e32498. doi: 10.5812/hepatmon.32498. eCollection 2015 Dec.
PubMed 26977164Mohamadnejad M, Vosough M, Moossavi S, Nikfam S, Mardpour S, Akhlaghpoor S, Ashrafi M, Azimian V, Jarughi N, Hosseini SE, Moeininia F, Bagheri M, Sharafkhah M, Aghdami N, Malekzadeh R, Baharvand H. Intraportal Infusion of Bone Marrow Mononuclear or CD133+ Cells in Patients With Decompensated Cirrhosis: A Double-Blind Randomized Controlled Trial. Stem Cells Transl Med. 2016 Jan;5(1):87-94. doi: 10.5966/sctm.2015-0004. Epub 2015 Dec 10.
PubMed 26659833Chen Y, Chen S, Liu LY, Zou ZL, Cai YJ, Wang JG, Chen B, Xu LM, Lin Z, Wang XD, Chen YP. Mesenchymal stem cells ameliorate experimental autoimmune hepatitis by activation of the programmed death 1 pathway. Immunol Lett. 2014 Dec;162(2 Pt B):222-8. doi: 10.1016/j.imlet.2014.10.021. Epub 2014 Oct 28.
PubMed 25445618
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autologous Bone Marrow Stem Cells Infusion for the Treatment of Liver Diseases.
- ClinicalTrials.gov ID
- NCT02943707
- Acronym / sponsor ID
- ABMSCIFTLD / 12330000470005914R
- Conditions
- Liver Diseases
- Keywords
- liver diseases, Bone Marrow Cell Transplantation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Wenzhou Medical UniversityUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Oct 2020 (estimated)
- First posted
- 25 Oct 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.
This study evaluates the effect of autologous bone marrow stem cells infusion (ABMSCi) therapy for liver diseases.Treatment group will receive ABMSCi and drugs therapy ,while control group will only receive drugs therapy.
Detailed description
- Autologous bone marrow stem cells (ABMSC) mobilization and harvest For harvesting more ABMSC, ABMSC mobilization is induced by recombinant human granulocyte colony stimulating factor (rhGCSF,Gran○R), administered subcutaneously at a dose of 300μg daily for three consecutive days before bone marrow puncture. Bone marrow (160-200ml) of the patients is harvested from both posterior superior iliacs according to standard procedures under local anaesthesia and is collected in a plastic bag containing heparin.
- Both treatment group and control group receive drugs therapy.
- ABMSC separation and infusion ABMSC is separated and purified in a class 10,000 clean laboratory. After fat and bony particles are removed by filtration, collected cells are moved to a cell-processing device. 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 is measured by an automated complete blood count instrument and flow cytometry analysis. The number of mononuclear cells is counted manually under a microscope by Wright-Giemsa stain method. Cell differentiation factor 34(CD34) positive cells were determined by flow cytometry analysis. The time of ABMSC separation and purification is 2.5-3 hours. ABMSC is added to 10 ml saline and well mixed by shaking the vial gently. The catheter is 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 . The mixture of saline and ABMSC is infused into proper hepatic artery at uniform speed for about two minutes. The catheter is removed after the ABMSCi.
- 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 analysis is performed using the Statistic Package for Social Science (SPSS). All statistical analysis is 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 |
|---|---|---|
| treatment group: ABMSCi & drugs | Experimental | Procedure: Autologous bone marrow stem cells infusion, Drug: drugs such as Ursodeoxycholic Acid tabletsABMSCi: Autologous bone marrow stem cells infusion drugs such as Ursodeoxycholic Acid tablets(UDCA), each time 150 mg, three times a day orally |
| control group: drugs | Active comparator | Drug: drugs such as Ursodeoxycholic Acid tabletsdrugs such as Ursodeoxycholic Acid tablets(UDCA), each time 150 mg, three times a day orally |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Definite liver diseases (such as viral hepatitis, autoimmune liver diseases, fatty liver diseases, ect);
- Active bone marrow hyperplasia showed by bone marrow biopsy before ABMSCi;
- Age between 18 and 60 years;
- Abnormal liver function.
Key exclusion criteria (7 listed)
- Enlisted for liver transplantation
- Diagnosis of hepatocellular carcinoma or other cancers
- Other severe medical disease, and acute infection
- pregnant or nursing females,co-infections with HIV ,serious bacterial infection
- other vital organ or system dysfunction
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 infusionAlso: ABMSCiAutologous bone marrow stem cells are infused into proper hepatic artery | Procedure or surgery | treatment group: ABMSCi & drugs |
| drugs such as Ursodeoxycholic Acid tabletsAlso: UDCAUrsodeoxycholic Acid tablets(UDCA), each time 150 mg, three times a day orally | Drug | control group: drugs, treatment group: ABMSCi & drugs |
Primary outcome
Change from baseline alanine aminotransferase at 6 months
Time frame: baseline and 6 months after treatment
alanine aminotransferase (ALT)
Change from baseline aspartate aminotransferase at 6 months
Time frame: baseline and 6 months after treatment
aspartate aminotransferase (AST)
Change from baseline total bilirubin at 6 months
Time frame: baseline and 6 months after treatment
total bilirubin (TBil)
Change from baseline direct bilirubin at 6 months
Time frame: baseline and 6 months after treatment
direct bilirubin (DBil)
Change from baseline total bile acid at 6 months
Time frame: baseline and 6 months after treatment
total bile acid (TBA)
Change from baseline albumin at 6 months
Time frame: baseline and 6 months after treatment
albumin (ALB)
Change from baseline prothrombin time at 6 months
Time frame: baseline and 6 months after treatment
prothrombin time (PT),
Change from baseline international normalized ratio at 6 months
Time frame: baseline and 6 months after treatment
international normalized ratio (INR)
Change from baseline white blood cell at 6 months
Time frame: baseline and 6 months after treatment
white blood cell (WBC)
Change from baseline platelet at 6 months
Time frame: baseline and 6 months after treatment
platelet (PLT)
7 secondary outcomes
Change from baseline liver density at 6 months
Time frame: baseline and 6 months after treatment
Change from baseline liver size at 6 months
Time frame: baseline and 6 months after treatment
Change from baseline spleen thickness at 6 months
Time frame: baseline and 6 months after treatment
Incidence of adverse events that are related to treatment
Time frame: baseline and 6 months after treatment
Number of participants that survive without developing disease
Time frame: 12 months after treatment
Number of participants that survive with developing disease
Time frame: 12 months after treatment
Number of participants that die after treatment
Time frame: 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 25 Oct 2016.
- Background: PubMed 25861263Ma XR, Tang YL, Xuan M, Chang Z, Wang XY, Liang XH. Transplantation of autologous mesenchymal stem cells for end-stage liver cirrhosis: a meta-analysis based on seven controlled trials. Gastroenterol Res Pract. 2015;2015:908275. doi: 10.1155/2015/908275. Epub 2015 Mar 15.
- Results publication: PubMed 24942592Xu L, Gong Y, Wang B, Shi K, Hou Y, Wang L, Lin Z, Han Y, Lu L, Chen D, Lin X, Zeng Q, Feng W, Chen Y. Randomized trial of autologous bone marrow mesenchymal stem cells transplantation for hepatitis B virus cirrhosis: regulation of Treg/Th17 cells. J Gastroenterol Hepatol. 2014 Aug;29(8):1620-8. doi: 10.1111/jgh.12653.
- Results publication: 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.
- Results publication: PubMed 26977164Deng Q, Cai T, Zhang S, Hu A, Zhang X, Wang Y, Huang J. Autologous Peripheral Blood Stem Cell Transplantation Improves Portal Hemodynamics in Patients with Hepatitis B Virus-related Decompensated Cirrhosis. Hepat Mon. 2015 Dec 20;15(12):e32498. doi: 10.5812/hepatmon.32498. eCollection 2015 Dec.
- Results publication: PubMed 26659833Mohamadnejad M, Vosough M, Moossavi S, Nikfam S, Mardpour S, Akhlaghpoor S, Ashrafi M, Azimian V, Jarughi N, Hosseini SE, Moeininia F, Bagheri M, Sharafkhah M, Aghdami N, Malekzadeh R, Baharvand H. Intraportal Infusion of Bone Marrow Mononuclear or CD133+ Cells in Patients With Decompensated Cirrhosis: A Double-Blind Randomized Controlled Trial. Stem Cells Transl Med. 2016 Jan;5(1):87-94. doi: 10.5966/sctm.2015-0004. Epub 2015 Dec 10.
- Results publication: PubMed 25445618Chen Y, Chen S, Liu LY, Zou ZL, Cai YJ, Wang JG, Chen B, Xu LM, Lin Z, Wang XD, Chen YP. Mesenchymal stem cells ameliorate experimental autoimmune hepatitis by activation of the programmed death 1 pathway. Immunol Lett. 2014 Dec;162(2 Pt B):222-8. doi: 10.1016/j.imlet.2014.10.021. Epub 2014 Oct 28.
- 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.
yongping chen 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?
A Phase 2 study testing Autologous bone marrow stem cells infusion and drugs such as Ursodeoxycholic Acid tablets in people with Liver Diseases, run by Wenzhou 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 4 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 25 Oct 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 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 yongping chen (8613505777281, 13505777281@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline alanine aminotransferase at 6 months (time frame: baseline and 6 months after treatment). The study lists 10 primary outcomes in all. 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 NCT02943707, which also lists 6 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 25 Oct 2016.