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Liver FailurePhase 1/2NCT01218464

Safety and Efficacy of Human Mesenchymal Stem Cells for Treatment of Liver Failure

A Phase 1/2 study testing Conventional plus MSC treatment and Conventional plus pacebo treatment in people with Liver Failure and Mesenchymal Stem Cells, run by Beijing 302 Hospital 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 The sponsor has not verified this record for over two years, so it may be out of date.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

Liver failure (LF) is a dramatic clinical syndrome with massive necrosis of liver cells. and liver transplantation is the only available therapeutic option for patients suffering with this condition. However, lack of donors, surgical complications, rejection, and high cost are serious problems. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Liver Failure, Mesenchymal Stem Cells
What is being tested?
Conventional plus MSC treatment and Conventional plus pacebo treatment
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
1 siteChina
Study dates
Mar 2009to Mar 2014
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 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Aged 18-70 years
  • Liver failure
  • Negative pregnancy test (female patients in fertile age)
  • Written consent

Who cannot join

  • Hepatocellular carcinoma or other malignancies
  • Severe problems in other vital organs(e.g.the heart,renal or lungs)
  • Pregnant or lactating women
  • Severe bacteria infection
  • Anticipated with difficulty of follow-up observation
  • Other candidates who are judged to be not applicable to this study by doctors

Trial locations and contacts

1 site in 1 country.

Fu-Sheng Wang, Professor contact

86-10-63879735 ext. 2015.12

fswang@public.bta.net.cn

China1 site, 1 recruiting

  • Beijing 302 Hospital

    Beijing, Beijing Municipality, 100039

    Ming Shi, Professor, 86-10-63879735 ext. 2015.12, shiming302@sina.com

    Recruiting

Other trials in China

About this study

Official title: Phase Ⅰ/Ⅱ Study of Human Umbilical Cord Derived Mesenchymal Stem Cells (UC-MSCs) for Treatment of Liver Failure

Liver failure (LF) is a dramatic clinical syndrome with massive necrosis of liver cells. and liver transplantation is the only available therapeutic option for patients suffering with this condition. However, lack of donors, surgical complications, rejection, and high cost are serious problems. Previous study showed that bone marrow derived mesenchymal stem cells (BM-MSCs) replace hepatocytes in injured liver, and effectively rescue experimental liver failure and contribute to liver regeneration. In this study, the patients with LF will undergo administration of human umbilical cord mesenchymal stem cells (UC-MSCs) via peripheral vein transfusion to evaluate the safty and efficacy of UC-MSCs treatment for these patients.

Read the detailed description

Liver failure (LF) is a severe life-threatening condition, and is a dramatic clinical syndrome with massive necrosis of liver cells, and liver transplantation is the only available therapeutic option for patients suffering with this condition. However, lack of donors, surgical complications, rejection, and high cost are serious problems. Since current therapeutic options for LF that is usually with extremely poor prognosis are still limited, recent studies indicate that mesenchymal stem cells (MSCs), due to their function in immune modulation and liver-damage repair, are of great therapeutic potential for this disease. Previous study showed that bone marrow derived mesenchymal stem cells (BM-MSCs) replace hepatocytes in injured liver, and effectively rescue experimental liver failure and contribute to liver regeneration.The purpose of this study is to investigate the safety and initial efficacy of human umbilical cord MSC (UC-MSCs) treatment for patients with LF. In this study, MSCs were isolated from umbilical cord and generated in appropriate growth medium. 50 LF patients with LF received i.v. transfusion of 0.5-1.0×106 cells/kg of MSCs as the treated group and other 20 LF patients with LF were transfused with placebo without MSCs as control group. All 70 of them received the routine management for liver failure. During the 2-year follow up, the evaluation of safty and efficacy will be undergone to help to establish innovative cell-based therapies for the treatment of diseases.

Being tested
Conventional plus MSC treatment, Conventional plus pacebo treatment
Keywords
Liver Failure, Mesenchymal Stem Cells, Model for End-Stage Liver Disease, Ascite, Serum Albumin
Medical subject headings
Liver Failure

What participants receive

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

  • Conventional plus MSC treatmentDrug

    Participants received conventional treatment and taken i.v., once per 4 week, at a dose of 0.5*10E6 MSC/kg body for 12 weeks.

  • Conventional plus pacebo treatmentDrug

    Participants received conventional treatment and taken i.v., once per 4 week, at 50 ml saline for 12 weeks.

Study groups in NCT01218464
Study groupRoleWhat they receive
Conventional plus MSC treatmentExperimentalParticipants will receive conventional treatment plus a dose of MSC from day 0 through the week 12 study visit. Participants will then be followed until 2 years study visit
Receives: Drug: Conventional plus MSC treatment
Conventional plus pacebo treatmentExperimentalParticipants will receive conventional plus placebo treatment from day 0 through the week 12 study visit. Participants will then be followed until 2 years study visit
Receives: Drug: Conventional plus pacebo treatment

What is being measured

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

  1. The levels of serum Total Protein and Albumin

    Measured: 2 years after treatment

Secondary outcomes (8)

  1. The levels of serum Total Bilirubin and Direct Bilirubin

    Measured: 2 years after treatment

  2. The levels of serum Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Cholinesterase (CHE)

    Measured: 2 years after treatment

  3. The level of alpha-fetoprotein (AFP)

    Measured: 2 years after treatment

  4. The content of ascites

    Measured: 2 years after treatment

  5. Survival rate and time

    Measured: 2 years after treatment

  6. Body temperature, tetter and allergy

    Measured: Between 0 to 24 hours after UC-MSCs transfusion

  7. The levels of Prothrombin Activity (PA) and Prothrombin Time (PT)

    Measured: 2 years after treatment

  8. The score for Model for End-Stage Liver Disease

    Measured: 2 years after treatment

Timeline

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

  1. First posted11 Oct 2010 (estimated)
  2. Study startMar 2009
  3. Primary completionMar 2014 (estimated)
  4. Study completionMar 2014 (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
Parallel groups
Masking
Double blind
Who is masked
Participant, Care provider
Enrolment
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01218464
Sponsor's protocol ID
Beijing302-003
Status last verified
May 2013
First submitted
8 Oct 2010
Last updated
31 May 2013
Results posted
No
Data monitoring committee
Yes

Publications

  • Kuo TK, Hung SP, Chuang CH, Chen CT, Shih YR, Fang SC, Yang VW, Lee OK. Stem cell therapy for liver disease: parameters governing the success of using bone marrow mesenchymal stem cells. Gastroenterology. 2008 Jun;134(7):2111-21, 2121.e1-3. doi: 10.1053/j.gastro.2008.03.015. Epub 2008 Mar 12.

    PubMed 18455168

  • Campard D, Lysy PA, Najimi M, Sokal EM. Native umbilical cord matrix stem cells express hepatic markers and differentiate into hepatocyte-like cells. Gastroenterology. 2008 Mar;134(3):833-48. doi: 10.1053/j.gastro.2007.12.024. Epub 2007 Dec 23.

    PubMed 18243183

  • 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

  • Mohamadnejad M, Alimoghaddam K, Mohyeddin-Bonab M, Bagheri M, Bashtar M, Ghanaati H, Baharvand H, Ghavamzadeh A, Malekzadeh R. Phase 1 trial of autologous bone marrow mesenchymal stem cell transplantation in patients with decompensated liver cirrhosis. Arch Iran Med. 2007 Oct;10(4):459-66.

    PubMed 17903050

  • Kharaziha P, Hellstrom PM, Noorinayer B, Farzaneh F, Aghajani K, Jafari F, Telkabadi M, Atashi A, Honardoost M, Zali MR, Soleimani M. Improvement of liver function in liver cirrhosis patients after autologous mesenchymal stem cell injection: a phase I-II clinical trial. Eur J Gastroenterol Hepatol. 2009 Oct;21(10):1199-205. doi: 10.1097/MEG.0b013e32832a1f6c.

    PubMed 19455046

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Conventional plus MSC treatment and Conventional plus pacebo treatment in people with Liver Failure and Mesenchymal Stem Cells, run by Beijing 302 Hospital 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 31 May 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 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 Fu-Sheng Wang, Professor (86-10-63879735 ext. 2015.12, fswang@public.bta.net.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The levels of serum Total Protein and Albumin (time frame: 2 years after treatment). 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 NCT01218464, 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 31 May 2013.

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