Liver CirrhosisPhase 1/2NCT03626090
Mesenchymal Stem Cell Therapy for Liver Cirrhosis
A Phase 1/2 study testing Autologous BM MSC in people with Liver Cirrhosis, run by Stem Med Pte. Ltd. at 3 sites in Singapore.
Trial summary
MSCs have been studied for the treatment of liver diseases as well as non-liver diseases. MSCs have been successful in treating conditions like acute steroid-resistant GVHD in hematopoietic stem cell transplanted patients and also have shown to improve the MELD score in end-stage liver disease. Read more about this study
- Who is it for?
- Ages 21 to 69 years
- Conditions the study is for
- Liver Cirrhosis
- What is being tested?
- Autologous BM MSC
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 3 sitesSingapore
- Study dates
- 18 Aug 2018to 22 Oct 2021
- 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 21 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must meet all the inclusive criteria to participate in the study:
- with definite liver cirrhosis, irrespective of aetiology
- must have Child's B or C stage
- must have signed an informed consent form
Who cannot join
- Subjects with any of the following criteria are regarded as an exclusion from the study and will not be permitted to participate:
- age ≤21 years and >70 years old
- with life expectancy of < 6 months
- cancers and bone marrow malignancies
- patients with an active infection or multiple infections
- patients with uncontrolled hypertension and diabetes
Show all 9Show fewer
- immunosuppressed patients (IST must have stopped at least 4 weeks prior to trial enrolment)
- patients who are HIV positive
- patients who are pregnant or lactating
Trial locations and contacts
3 sites in 1 country.
Singapore3 sites, 3 recruiting
- Recruiting
Asian American Liver Centre - Gleneagles Hospital (Annexe Block)
Singapore, 258500
Clinical Trial Department, 63699191, clinicaltrials@stem-med.sg
Lee Kang Hoe
- Recruiting
Parkway Cancer Centre - Gleneagles Hospital
Singapore, 258500
Clinical Trial Department, 63699191, clinicaltrials@stem-med.sg
Teo Cheng Peng
- Recruiting
Desmond Wai Liver & Gastrointestinal Disease Centre - Mount Elizabeth Novena Specialist Centre
Singapore, 329563
Clinical Trial Department, 63699191, clinicaltrials@stem-med.sg
Wai Chun Tao, Desmond
About this study
Official title: Mesenchymal Stem Cell Therapy for Liver Cirrhosis: A Phase I/II Study
MSCs have been studied for the treatment of liver diseases as well as non-liver diseases. MSCs have been successful in treating conditions like acute steroid-resistant GVHD in hematopoietic stem cell transplanted patients and also have shown to improve the MELD score in end-stage liver disease. There were no severe side effects observed in using autologous MSCs as a treatment option. The outcome of the studies done so far have been positive and it is encouraged to study the use of MSCs as cell therapy for treating liver diseases.
The estimated rate of cirrhosis in HBV patients in Singapore is about 1.6% per year, rate of hepatocellular carcinoma is about 0.8% per year overall and 3.0% per year in cirrhotic patients. Knowing that there are not many options currently available for Liver Cirrhosis patients and that they have a poor prognosis with an average life expectancy of < 12 months, this study uses autologous MSCs to treat Liver Cirrhosis patients in Singapore. The objective of the study is to demonstrate that autologous bone marrow is safe to be used in patients with liver cirrhosis as well as demonstrate that bone marrow MSC may improve liver function and prolong patient survival.
Read the detailed description
Liver cirrhosis refers to extreme scarring of the liver, resulting in suboptimal function of the liver. It can result from a variety of causes, ranging from hepatitis B and C infection, excessive alcohol consumption, autoimmune causes, fatty liver and others. Irrespective of the cause, once the liver becomes cirrhotic, it is a downhill course.
Liver cirrhosis is irreversible and most patients will progressively worsen over time. Once liver cirrhosis has reached the stage of decompensation, that is, development of jaundice, ascites, variceal bleeding, hepatic encephalopathy and coagulopathy the two-year survival drops to about 50%.
The definitive treatment of decompensated cirrhosis is liver transplantation. While a liver transplantation is potentially curative, the high costs, lack of a donor, treatment-related mortality and the immunosuppression complications make this option possible only for a limited number of patients. The vast majority do not have an effective option at all, thus the need to develop alternative therapies. Various types of Stem Cells had been investigated as a regenerative therapy for liver cirrhosis. These stem cells include bone marrow mesenchymal stem cells (MSC), bone marrow mononuclear cells (MNC) and peripheral CD34 positive cells. Some early studies have shown encouraging results in patients who had autologous bone marrow stem cell transplantation. There was improved liver function in these patients with cirrhotic livers.
The sponsor is proposing a study to look into the role of MSC therapy for patients with liver cirrhosis in Singapore. This will be a Phase I/II study with the main emphasis on the safety profile first. The trial will be conducted in compliance with the protocol, GCP and local regulatory requirement(s).
- Conditions
- Liver Cirrhosis
- Being tested
- Autologous BM MSC
- Keywords
- Liver, Cirrhosis, Child B, Child C, Advance, Advanced, Singapore, MSC, Mesenchymal, Stem Cell, Cell Therapy, MSC Therapy, Treatment
- Medical subject headings
- Liver Cirrhosis, Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous BM MSCBiological
A total of 100-200ml will be harvested from the subject, in either a single or multiple punctures. This will be processed for autologous MSC infusion.
| Study group | Role | What they receive |
|---|---|---|
| Treatment Arm | Experimental | A single dose of 0.5 to 1 x 10^6/kg autologous BM MSCs (Total volume: 30 - 50 ml) will be infused via peripheral venous access. Receives: Biological: Autologous BM MSC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Examination
To observe for the following:
- absence of grade IV anaphylactic reactions (in reference to CTCAE 4.03)
- absence of grade IV febrile reactions or septic/ infective complications (in reference to CTCAE 4.03).
Measured: Up to 34 weeks
MR Elastography
To detect liver stiffness
Measured: Up to 34 weeks
The level of serum alanine aminotransferase (ALT)
To ensure the absence of deterioration of liver function.
Measured: Up to 34 weeks
The level of glomerular filtration rate (GFR)
To ensure the absence of deterioration of renal function.
Measured: Up to 34 weeks
Secondary outcomes (4)
The level of serum prothrombin time (PT)
To assess the efficacy of treatment
Measured: Up to 6 months, post-infusion
The level of serum total bilirubin (TB)
To assess the efficacy of treatment
Measured: Up to 6 months, post-infusion
The level of serum albumin (ALB)
To assess the efficacy of treatment
Measured: Up to 6 months, post-infusion
MELD Score
To assess the efficacy of treatment
Measured: Up to 6 months, post-infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2018
- Study start18 Aug 2018
- Primary completion22 Oct 2021 (estimated)
- Study completion22 Oct 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (56)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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- As the primary objective of the study is to assess safety of MSC infusion, a single arm non-blinded study design has been adopted.
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stem Med Pte. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Parkway Cancer Centre, Asian American Liver Centre, Desmond Wai Liver & Gastrointestinal Diseases Centre
- Responsible party
- Sponsor
- Investigators
- Teo Cheng Peng, Principal investigator, Parkway Cancer CentreWai Chun Tao, Desmond, Principal investigator, Desmond Wai Liver & Gastrointestinal Diseases CentreLee Kang Hoe, Principal investigator, Asian American Liver Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03626090
- Sponsor's protocol ID
- P-SM-L0001
- Status last verified
- Mar 2021
- First submitted
- 26 Jul 2018
- Last updated
- 17 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Poh Z, Goh BB, Chang PE, Tan CK. Rates of cirrhosis and hepatocellular carcinoma in chronic hepatitis B and the role of surveillance: a 10-year follow-up of 673 patients. Eur J Gastroenterol Hepatol. 2015 Jun;27(6):638-43. doi: 10.1097/MEG.0000000000000341.
PubMed 25831135Lyra AC, Soares MB, da Silva LF, Fortes MF, Silva AG, Mota AC, Oliveira SA, Braga EL, de Carvalho WA, Genser B, dos Santos RR, Lyra LG. Feasibility and safety of autologous bone marrow mononuclear cell transplantation in patients with advanced chronic liver disease. World J Gastroenterol. 2007 Feb 21;13(7):1067-73. doi: 10.3748/wjg.v13.i7.1067.
PubMed 17373741Terai 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 16778155Peng 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 21608000Zhao DC, Lei JX, Chen R, Yu WH, Zhang XM, Li SN, Xiang P. Bone marrow-derived mesenchymal stem cells protect against experimental liver fibrosis in rats. World J Gastroenterol. 2005 Jun 14;11(22):3431-40. doi: 10.3748/wjg.v11.i22.3431.
PubMed 15948250Ortiz LA, Gambelli F, McBride C, Gaupp D, Baddoo M, Kaminski N, Phinney DG. Mesenchymal stem cell engraftment in lung is enhanced in response to bleomycin exposure and ameliorates its fibrotic effects. Proc Natl Acad Sci U S A. 2003 Jul 8;100(14):8407-11. doi: 10.1073/pnas.1432929100. Epub 2003 Jun 18.
PubMed 12815096Meier RP, Muller YD, Morel P, Gonelle-Gispert C, Buhler LH. Transplantation of mesenchymal stem cells for the treatment of liver diseases, is there enough evidence? Stem Cell Res. 2013 Nov;11(3):1348-64. doi: 10.1016/j.scr.2013.08.011. Epub 2013 Aug 29.
PubMed 24090934Amorin B, Alegretti AP, Valim V, Pezzi A, Laureano AM, da Silva MA, Wieck A, Silla L. Mesenchymal stem cell therapy and acute graft-versus-host disease: a review. Hum Cell. 2014 Oct;27(4):137-50. doi: 10.1007/s13577-014-0095-x. Epub 2014 Jun 6.
PubMed 24903975Jacobs SA, Roobrouck VD, Verfaillie CM, Van Gool SW. Immunological characteristics of human mesenchymal stem cells and multipotent adult progenitor cells. Immunol Cell Biol. 2013 Jan;91(1):32-9. doi: 10.1038/icb.2012.64.
PubMed 23295415Uccelli A, Moretta L, Pistoia V. Mesenchymal stem cells in health and disease. Nat Rev Immunol. 2008 Sep;8(9):726-36. doi: 10.1038/nri2395.
PubMed 19172693Di Nicola M, Carlo-Stella C, Magni M, Milanesi M, Longoni PD, Matteucci P, Grisanti S, Gianni AM. Human bone marrow stromal cells suppress T-lymphocyte proliferation induced by cellular or nonspecific mitogenic stimuli. Blood. 2002 May 15;99(10):3838-43. doi: 10.1182/blood.v99.10.3838.
PubMed 11986244Krampera M, Glennie S, Dyson J, Scott D, Laylor R, Simpson E, Dazzi F. Bone marrow mesenchymal stem cells inhibit the response of naive and memory antigen-specific T cells to their cognate peptide. Blood. 2003 May 1;101(9):3722-9. doi: 10.1182/blood-2002-07-2104. Epub 2002 Dec 27.
PubMed 12506037Meisel R, Zibert A, Laryea M, Gobel U, Daubener W, Dilloo D. Human bone marrow stromal cells inhibit allogeneic T-cell responses by indoleamine 2,3-dioxygenase-mediated tryptophan degradation. Blood. 2004 Jun 15;103(12):4619-21. doi: 10.1182/blood-2003-11-3909. Epub 2004 Mar 4.
PubMed 15001472Suva D, Passweg J, Arnaudeau S, Hoffmeyer P, Kindler V. In vitro activated human T lymphocytes very efficiently attach to allogenic multipotent mesenchymal stromal cells and transmigrate under them. J Cell Physiol. 2008 Mar;214(3):588-94. doi: 10.1002/jcp.21244.
PubMed 17786951Kisseleva T, Cong M, Paik Y, Scholten D, Jiang C, Benner C, Iwaisako K, Moore-Morris T, Scott B, Tsukamoto H, Evans SM, Dillmann W, Glass CK, Brenner DA. Myofibroblasts revert to an inactive phenotype during regression of liver fibrosis. Proc Natl Acad Sci U S A. 2012 Jun 12;109(24):9448-53. doi: 10.1073/pnas.1201840109. Epub 2012 May 7.
PubMed 22566629
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mesenchymal Stem Cell Therapy for Liver Cirrhosis: A Phase I/II Study
- ClinicalTrials.gov ID
- NCT03626090
- Acronym / sponsor ID
- P-SM-L0001
- Conditions
- Liver Cirrhosis
- Keywords
- Liver, Cirrhosis, Child B, Child C, Advance, Advanced, Singapore, MSC
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Stem Med Pte. Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Parkway Cancer Centre, Asian American Liver Centre, Desmond Wai Liver & Gastrointestinal Diseases Centre
- Study start
- 18 Aug 2018 (actual)
- Primary completion
- 22 Oct 2021 (estimated)
- Study completion
- 22 Oct 2021 (estimated)
- First posted
- 10 Aug 2018 (actual)
- 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.
MSCs have been studied for the treatment of liver diseases as well as non-liver diseases. MSCs have been successful in treating conditions like acute steroid-resistant GVHD in hematopoietic stem cell transplanted patients and also have shown to improve the MELD score in end-stage liver disease. There were no severe side effects observed in using autologous MSCs as a treatment option. The outcome of the studies done so far have been positive and it is encouraged to study the use of MSCs as cell therapy for treating liver diseases.
The estimated rate of cirrhosis in HBV patients in Singapore is about 1.6% per year, rate of hepatocellular carcinoma is about 0.8% per year overall and 3.0% per year in cirrhotic patients. Knowing that there are not many options currently available for Liver Cirrhosis patients and that they have a poor prognosis with an average life expectancy of < 12 months, this study uses autologous MSCs to treat Liver Cirrhosis patients in Singapore. The objective of the study is to demonstrate that autologous bone marrow is safe to be used in patients with liver cirrhosis as well as demonstrate that bone marrow MSC may improve liver function and prolong patient survival.
Detailed description
Liver cirrhosis refers to extreme scarring of the liver, resulting in suboptimal function of the liver. It can result from a variety of causes, ranging from hepatitis B and C infection, excessive alcohol consumption, autoimmune causes, fatty liver and others. Irrespective of the cause, once the liver becomes cirrhotic, it is a downhill course.
Liver cirrhosis is irreversible and most patients will progressively worsen over time. Once liver cirrhosis has reached the stage of decompensation, that is, development of jaundice, ascites, variceal bleeding, hepatic encephalopathy and coagulopathy the two-year survival drops to about 50%.
The definitive treatment of decompensated cirrhosis is liver transplantation. While a liver transplantation is potentially curative, the high costs, lack of a donor, treatment-related mortality and the immunosuppression complications make this option possible only for a limited number of patients. The vast majority do not have an effective option at all, thus the need to develop alternative therapies. Various types of Stem Cells had been investigated as a regenerative therapy for liver cirrhosis. These stem cells include bone marrow mesenchymal stem cells (MSC), bone marrow mononuclear cells (MNC) and peripheral CD34 positive cells. Some early studies have shown encouraging results in patients who had autologous bone marrow stem cell transplantation. There was improved liver function in these patients with cirrhotic livers.
The sponsor is proposing a study to look into the role of MSC therapy for patients with liver cirrhosis in Singapore. This will be a Phase I/II study with the main emphasis on the safety profile first. The trial will be conducted in compliance with the protocol, GCP and local regulatory requirement(s).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- As the primary objective of the study is to assess safety of MSC infusion, a single arm non-blinded study design has been adopted.
| Arm | Type | Receives |
|---|---|---|
| Treatment Arm | Experimental | Biological: Autologous BM MSCA single dose of 0.5 to 1 x 10^6/kg autologous BM MSCs (Total volume: 30 - 50 ml) will be infused via peripheral venous access. |
Who may qualify
- Ages
- 21 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- with definite liver cirrhosis, irrespective of aetiology
- must have Child's B or C stage
- must have signed an informed consent form
Key exclusion criteria (9 listed)
- Subjects with any of the following criteria are regarded as an exclusion from the study and will not be permitted to participate:
- age ≤21 years and >70 years old
- with life expectancy of < 6 months
- cancers and bone marrow malignancies
- patients with an active infection or multiple infections
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 BM MSCA total of 100-200ml will be harvested from the subject, in either a single or multiple punctures. This will be processed for autologous MSC infusion. | Biological | Treatment Arm |
Primary outcome
Clinical Examination
Time frame: Up to 34 weeks
To observe for the following: * absence of grade IV anaphylactic reactions (in reference to CTCAE 4.03) * absence of grade IV febrile reactions or septic/ infective complications (in reference to CTCAE 4.03).
MR Elastography
Time frame: Up to 34 weeks
To detect liver stiffness
The level of serum alanine aminotransferase (ALT)
Time frame: Up to 34 weeks
To ensure the absence of deterioration of liver function.
The level of glomerular filtration rate (GFR)
Time frame: Up to 34 weeks
To ensure the absence of deterioration of renal function.
4 secondary outcomes
The level of serum prothrombin time (PT)
Time frame: Up to 6 months, post-infusion
The level of serum total bilirubin (TB)
Time frame: Up to 6 months, post-infusion
The level of serum albumin (ALB)
Time frame: Up to 6 months, post-infusion
MELD Score
Time frame: Up to 6 months, post-infusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2021.
- Background: PubMed 25831135Poh Z, Goh BB, Chang PE, Tan CK. Rates of cirrhosis and hepatocellular carcinoma in chronic hepatitis B and the role of surveillance: a 10-year follow-up of 673 patients. Eur J Gastroenterol Hepatol. 2015 Jun;27(6):638-43. doi: 10.1097/MEG.0000000000000341.
- Background: PubMed 17373741Lyra AC, Soares MB, da Silva LF, Fortes MF, Silva AG, Mota AC, Oliveira SA, Braga EL, de Carvalho WA, Genser B, dos Santos RR, Lyra LG. Feasibility and safety of autologous bone marrow mononuclear cell transplantation in patients with advanced chronic liver disease. World J Gastroenterol. 2007 Feb 21;13(7):1067-73. doi: 10.3748/wjg.v13.i7.1067.
- 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.
- 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 15948250Zhao DC, Lei JX, Chen R, Yu WH, Zhang XM, Li SN, Xiang P. Bone marrow-derived mesenchymal stem cells protect against experimental liver fibrosis in rats. World J Gastroenterol. 2005 Jun 14;11(22):3431-40. doi: 10.3748/wjg.v11.i22.3431.
- Background: PubMed 12815096Ortiz LA, Gambelli F, McBride C, Gaupp D, Baddoo M, Kaminski N, Phinney DG. Mesenchymal stem cell engraftment in lung is enhanced in response to bleomycin exposure and ameliorates its fibrotic effects. Proc Natl Acad Sci U S A. 2003 Jul 8;100(14):8407-11. doi: 10.1073/pnas.1432929100. Epub 2003 Jun 18.
- Background: PubMed 24090934Meier RP, Muller YD, Morel P, Gonelle-Gispert C, Buhler LH. Transplantation of mesenchymal stem cells for the treatment of liver diseases, is there enough evidence? Stem Cell Res. 2013 Nov;11(3):1348-64. doi: 10.1016/j.scr.2013.08.011. Epub 2013 Aug 29.
- Background: PubMed 24903975Amorin B, Alegretti AP, Valim V, Pezzi A, Laureano AM, da Silva MA, Wieck A, Silla L. Mesenchymal stem cell therapy and acute graft-versus-host disease: a review. Hum Cell. 2014 Oct;27(4):137-50. doi: 10.1007/s13577-014-0095-x. Epub 2014 Jun 6.
- Background: PubMed 23295415Jacobs SA, Roobrouck VD, Verfaillie CM, Van Gool SW. Immunological characteristics of human mesenchymal stem cells and multipotent adult progenitor cells. Immunol Cell Biol. 2013 Jan;91(1):32-9. doi: 10.1038/icb.2012.64.
- Background: PubMed 19172693Uccelli A, Moretta L, Pistoia V. Mesenchymal stem cells in health and disease. Nat Rev Immunol. 2008 Sep;8(9):726-36. doi: 10.1038/nri2395.
- Background: PubMed 11986244Di Nicola M, Carlo-Stella C, Magni M, Milanesi M, Longoni PD, Matteucci P, Grisanti S, Gianni AM. Human bone marrow stromal cells suppress T-lymphocyte proliferation induced by cellular or nonspecific mitogenic stimuli. Blood. 2002 May 15;99(10):3838-43. doi: 10.1182/blood.v99.10.3838.
- Background: PubMed 12506037Krampera M, Glennie S, Dyson J, Scott D, Laylor R, Simpson E, Dazzi F. Bone marrow mesenchymal stem cells inhibit the response of naive and memory antigen-specific T cells to their cognate peptide. Blood. 2003 May 1;101(9):3722-9. doi: 10.1182/blood-2002-07-2104. Epub 2002 Dec 27.
- Individual participant dataSharing planned: No
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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.
Teo Cheng Peng principal investigator
Parkway Cancer Centre
Wai Chun Tao, Desmond principal investigator
Desmond Wai Liver & Gastrointestinal Diseases Centre
Lee Kang Hoe principal investigator
Asian American Liver Centre
3 sites 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 Autologous BM MSC in people with Liver Cirrhosis, run by Stem Med Pte. Ltd. at 3 sites in Singapore.
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 9 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 17 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Singapore. 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 Clinical Trial Department (63699191, clinicaltrials@stem-med.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Examination (time frame: Up to 34 weeks). The study lists 4 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 NCT03626090, which also lists 56 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 17 Mar 2021.