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Liver CirrhosisPhase 1/2NCT01483248

Human Menstrual Blood-derived Mesenchymal Stem Cells for Patients With Liver Cirrhosis

A Phase 1/2 study testing conventional therapy plus MenSC transplantation in people with Liver Cirrhosis and Fibrosis, run by S-Evans Biosciences Co., Ltd. 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 The sponsor has not verified this record for over two years, so it may be out of date.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

Orthotopic liver transplantation (OLT) is currently the most effective method for end-stage liver diseases. However, the critical shortage of donor organs, high cost, and the problem of immune rejection limit its clinical application, and even some patients on the waiting list will never survive to receive a matched… Read more about this study

Who is it for?
Ages 20 to 50 years, women only
Conditions the study is for
Liver Cirrhosis, Fibrosis, Liver Disease
What is being tested?
conventional therapy plus MenSC transplantation
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
50 participants
Where
1 siteChina
Study dates
Oct 2010to Oct 2015
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 20 to 50 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Written informed consent
  • Aged 20 to 50years
  • Liver cirrhosis
  • Negative pregnancy test

Who cannot join

  • Pregnant or lactating women
  • Malignancies
  • Sepsis
  • Vital organs failure
  • Severe bacteria infection
  • Vascular thromboses in the portal or hepatic veins

Trial locations and contacts

1 site in 1 country.

China1 site

  • the First Affiliated Hospital of Zhejiang University-IRB

    Hangzhou, Zhejiang, 310003

Other trials in China

About this study

Official title: Phase 1/2 Study of Human Menstrual Blood-derived Mesenchymal Stem Cells Transplantation for the Evaluation of the Efficacy and Safety in Patients With Liver Cirrhosis

Orthotopic liver transplantation (OLT) is currently the most effective method for end-stage liver diseases. However, the critical shortage of donor organs, high cost, and the problem of immune rejection limit its clinical application, and even some patients on the waiting list will never survive to receive a matched liver. Stem cell transplantation instead of conventional medical therapy or orthotopic liver transplantation will be a promising alternate approach to regenerate damaged hepatic mass. Adult mesenchymal stem cells (MSCs) are generally thought of as an autologous source of regenerative cells in previous studies.In this study, the safety and efficacy of menstrual blood-derived stem cells transplantation for patients with liver cirrhosis will be evaluated.

Read the detailed description

The purpose of this study is to show whether menstrual blood-derived stem cells can improve the disease conditions in patients with liver cirrhosis.

One of two treatment arms will be assigned to the patients. One group will receive 2 weeks of conventional therapy plus MenSCs treatment; The other group will receive 2 weeks of conventional therapy plus placebo treatment.

MenSCs will be cultured and collected in a GMP lab. Patients were strictly monitored after the cells injection via i.v.. Patients are followed up at intervals up to at least 2 years.Clinical parameters such as ascites volume,serum alanine aminotransferase,total bilirubin,prothrombin time,albumin,MELD score,and Child-Pugh score will be evaluated at each timepoint.

Being tested
conventional therapy plus MenSC transplantation, Conventional therapy plus placebo treatment
Keywords
Menstrual blood, Mesenchymal stem cell, Liver cirrhosis
Medical subject headings
Liver Cirrhosis, Fibrosis, Liver Diseases, Digestive System Diseases

What participants receive

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

  • conventional therapy plus MenSC transplantationBiological

    Also called Interferon, Bifendatatum, Ursodeoxycholic Acid, Menstrual blood-derived stem cells(MenSCs)

    patients will receive conventional treatment,such as antiviral drugs, lowering aminotransferase and jaundice medicine.

    MenSCs transplantation: taken i.v., twice per week, at a dose of 1*10E6 MSC/kg body for 2 weeks.

  • Conventional therapy plus placebo treatmentDrug

    Also called Interferon, Bifendatatum, Ursodeoxycholic Acid

    25 of the enrolled patients were assigned to receive comprehensive treatment including antiviral drugs, lowering aminotransferase and jaundice medicine.

Study groups in NCT01483248
Study groupRoleWhat they receive
InterventionExperimentalConventional therapy plus MenSCs treatment
Receives: Biological: conventional therapy plus MenSC transplantation
No interventionActive comparatorConventional therapy plus placebo treatment: Oral or intravenous administration
Receives: Drug: Conventional therapy plus placebo treatment

What is being measured

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

  1. Overall Survival

    Measured: 48 weeks

Secondary outcomes (6)

  1. Liver function improvement

    Measured: 48 weeks

  2. Complications

    such as fever,anaphylaxis,cough,chest distress,and dyspnea,et al.

    Measured: 48 weeks

  3. The improvement of ascites after 12-week treatment

    Measured: 48 weeks

  4. Child-Pugh score

    Measured: 48 weeks

  5. MELD score

    Measured: 48 weeks

  6. SF36-quality of life

    Measured: 48 weeks

Timeline

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

  1. First posted1 Dec 2011 (estimated)
  2. Study startOct 2010
  3. Primary completionOct 2013 (estimated)
  4. Study completionOct 2015 (estimated)

Resources

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
Randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01483248
Sponsor's protocol ID
SEB-1115-LC
Status last verified
Jun 2012
First submitted
23 Nov 2011
Last updated
7 Jun 2012
Results posted
No
Data monitoring committee
Yes

Publications

  • Houlihan DD, Hopkins LJ, Suresh SX, Armstrong MJ, Newsome PN. Autologous bone marrow mesenchymal stem cell transplantation in liver failure patients caused by hepatitis B: short-term and long-term outcomes. Hepatology. 2011 Nov;54(5):1891-2; author reply 1892. doi: 10.1002/hep.24722. No abstract available.

    PubMed 21987440

  • 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

  • Forbes SJ, Newsome PN. New horizons for stem cell therapy in liver disease. J Hepatol. 2012 Feb;56(2):496-9. doi: 10.1016/j.jhep.2011.06.022. Epub 2011 Jul 26.

    PubMed 21798218

  • Nikeghbalian S, Pournasr B, Aghdami N, Rasekhi A, Geramizadeh B, Hosseini Asl SM, Ramzi M, Kakaei F, Namiri M, Malekzadeh R, Vosough Dizaj A, Malek-Hosseini SA, Baharvand H. Autologous transplantation of bone marrow-derived mononuclear and CD133(+) cells in patients with decompensated cirrhosis. Arch Iran Med. 2011 Jan;14(1):12-7.

    PubMed 21194255

  • Zhang D, Jiang M, Miao D. Transplanted human amniotic membrane-derived mesenchymal stem cells ameliorate carbon tetrachloride-induced liver cirrhosis in mouse. PLoS One. 2011 Feb 4;6(2):e16789. doi: 10.1371/journal.pone.0016789.

    PubMed 21326862

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing conventional therapy plus MenSC transplantation in people with Liver Cirrhosis and Fibrosis, run by S-Evans Biosciences Co., 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 4 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 7 Jun 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 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?

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?

Overall Survival (time frame: 48 weeks). 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 NCT01483248, which also lists 5 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 7 Jun 2012.

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