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Liver CirrhosisPhase 1/2LCNCT01573923

Safety and Efficacy Study of Umbilical Mesenchymal Stem Cells for Liver Cirrhosis

A Phase 1/2 study testing mesenchymal stem cells and Conventional therapy in people with Liver Cirrhosis, run by Alliancells Bioscience Corporation Limited at 6 sites 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 The sponsor has not verified this record for over two years, so it may be out of date.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 cirrhosis and subsequent liver failure are leading causes of morbidity and mortality worldwide. Alcohol abuse and viral hepatitis are the most common causes of cirrhosis. Novel therapies are necessary to prevent or block the process of the disease. Read more about this study

Who is it for?
Ages 30 to 60 years
Conditions the study is for
Liver Cirrhosis
What is being tested?
mesenchymal stem cells and Conventional therapy
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
320 participants
Where
6 sitesChina
Study dates
Jul 2014to 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 30 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • written informed consent
  • aged 30-60 years
  • clinical diagnosis of compensated or decompensated liver
  • child-Pugh B/C (7-12 points)
  • expecting lifetime is over three years

Who cannot join

  • pregnant woman
  • patient with severe vascular diseases
  • patient with any organ failure
  • patient with any tumors
  • patient with HIV
  • patient who has been transplanted
Show all 9Show fewer
  • patient treated with immunosuppressors
  • patient for whom the follow-up is considered impossible
  • patients with any disease or condition which the investigator or treating physician feels would interfere with the trial or the safety of the subject

Trial locations and contacts

6 sites in 1 country.

Xuetao Pei, MD,PhD contact

86-10-68214650

peixt@nic.bmi.ac.cn

Haijie Ji, MD contact

86-10-63188853

jihaijie82@sohu.com

6 sites in 1 country

China6 sites, 6 recruiting

  • The 302 Hospital of Chinese People's Liberation Army

    Beijing, Beijing Municipality

    Hanwei Li, MD, PhD

    Recruiting

  • the First Affiliated Hospital of Lanzhou University

    Lanzhou, Gansu

    Xun Li, MD, PhD

    Xun Li, MD

    Recruiting

  • The first people's hospital of Lianyungang

    Lianyungang, Jiangsu, 222002

    Hui Shi, MD

    Hui Shi, MD

    Recruiting

  • Hainan BOAO Life infinity international anti-aging medical center

    Qionghai, Hainan, 571434

    Jiang Shu, Jiang.st@hotmail.com

    Recruiting

  • Tongji Hospital of Tongji University

    Shanghai, Shanghai Municipality

    Liming Chen, MD, PhD

    Jianwei Lu, PhD

    Recruiting

  • The 323 Hospital of Chinese People's Liberation Army

    Xi’an, Shanxi, 710054

    Liming Wang, MD, 86-29-84756502, wanglm@fmmu.edu.cn

    Liming Wang, MD

    Recruiting

Other trials in China

About this study

Official title: Clinical Trial of Umbilical Mesenchymal Stem Cells Transplantation for Liver Cirrhosis-Phase I/II

Liver cirrhosis and subsequent liver failure are leading causes of morbidity and mortality worldwide. Alcohol abuse and viral hepatitis are the most common causes of cirrhosis. Novel therapies are necessary to prevent or block the process of the disease. In this current prospective cohort, the investigators plan to organize four hospitals to determine the safety and efficacy of intravenous administration of umbilical mesenchymal stem cells in the treatment of patients with liver cirrhosis in next three years.

Conditions
Liver Cirrhosis
Being tested
mesenchymal stem cells, Conventional therapy
Keywords
Umbilical Mesenchymal Stem Cells; Liver cirrhosis
Medical subject headings
Liver Cirrhosis

What participants receive

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

  • mesenchymal stem cellsBiological

    Conventional therapy plus UC-MSC intravenous administration (4x107/40ml, once per three months, four times in one year)

  • Conventional therapyBiological

    Conventional therapy without cell therapy

Study groups in NCT01573923
Study groupRoleWhat they receive
Conventional therapySham comparatoronly apply for conventional medical therapy without any cell therapy
Receives: Biological: Conventional therapy
mesenchymal stem cellsActive comparatorcombination of conventional therapy with umbilical mesenchymal stem cells intravenous injection, (4x107/40ml, once per three months, four times in one year)
Receives: Biological: mesenchymal stem cells

What is being measured

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

  1. survival time

    Measured: 3-year follow up

Secondary outcomes (6)

  1. Serum markers regarding liver and kidney function

    liver functions：Albumin (ALB), Alanine aminotransferase (ALT), Aspartate Aminotransferase (AST), Prealbumin(PA), total bilirubin (TB), and direct bilirubin (DB) kidney function：Blood urea nitrogen (BUN), Urea (UA), and Crea (Cr)

    Measured: 0, 3, 6, 9 and 12 months

  2. Serum markers regarding lipid and sugar profile

    Total cholesterol (TC), high density lipoprotein cholesterol (HDL-C), low density lipoprotein cholesterol (LDL-C), triglycerides (TG), very low density lipoprotein cholesterol (VLDL-C), and Non-HDL-C; blood sugar;

    Measured: 0, 3, 6, 9 and 12 months

  3. Serum markers regarding cytokine profile

    IL-1β, IL-4, IL-6, IL-8, IL-10, IL-12(p40), IL-15, IL-17A, TNFα, TNFβ, IFN-γ, RANTES, TGFβ, lymphotactin, and C-reactive protein level (CRP)

    Measured: 0, 3, 6, 9 and 12 months

  4. Serum levels of Hepatitis B and C

    Serum levels of Hepatitis B and C

    Measured: 0, 3, 6, 9 and 12 months

  5. tolerance and the adverse events

    The classification for uncomfortable reaction is: 0, no discomfort; 1, slightly unwell, does not affect daily life; 2, moderate discomfort, affects daily life and work; 3, moderately unwell, significantly affects life, and bed rest; 4, severely unwell, life-threatening.

    A serious adverse event is defined as fatal, life threatening, permanently disabling, and tumors, particularly hepatocellular carcinoma.

    Measured: 3-year follow up

  6. Changes of any clinical symptoms

    abdominal distension, appetite, debilitation, and edema of lower limbs.

    Measured: 3-year follow up

Timeline

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

  1. First posted10 Apr 2012 (estimated)
  2. Study startJul 2014
  3. Primary completionJul 2015 (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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
320 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01573923
Sponsor's protocol ID
Alliancells-2012-1
Acronym
LC
Status last verified
Apr 2012
First submitted
6 Apr 2012
Last updated
14 Apr 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing mesenchymal stem cells and Conventional therapy in people with Liver Cirrhosis, run by Alliancells Bioscience Corporation Limited at 6 sites 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 5 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 14 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites 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. Some participants in this study may receive a placebo. 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 Xuetao Pei, MD,PhD (86-10-68214650, peixt@nic.bmi.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

survival time (time frame: 3-year follow up). 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 NCT01573923.

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 14 Apr 2015.

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