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Liver CirrhosisEarly Phase 1NCT03957655

Safety and Efficacy of SHED for Decompensated Liver Cirrhosis

A Early Phase 1 study testing SHED group in people with Liver Cirrhosis, run by Changhai 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 The sponsor has not verified this record for over two years, so it may be out of date.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

This study is an prospective, randomized control study. Patients with decompensated cirrhosis will be randomly assigned to receive 4 times of SHED treatment plus standard medical care(treatment）or standard medical care (control). The primary outcome is MELD-Na score. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Liver Cirrhosis
What is being tested?
SHED group
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteChina
Study dates
2 Dec 2019to 31 Dec 2021
Phase
Early Phase 1
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
  • HBV-related liver cirrhosis with presentations of decompensation
  • Antiviral treatment with nucleotide drugs for more than half a year and HBV DNA is less than the minimum detection limit;
  • Child-Pugh score B and MELD-Na score≤25
  • Written consent

Who cannot join

  • Hepatic encephalopathy, hepatorenal syndrome, acute phase of severe hepatitis
  • Child-Pugh score A or C
  • Hepatocellular carcinoma or other malignancies
  • Cirrhosis or liver failure caused by non-Hepatitis B
  • Pregnancy or breastfeeding
  • Severe bacteria infection,coinfection with HIV or other viral hepatitis.
Show all 10Show fewer
  • History of severe allergy to biological products or history of immunization within half a year
  • Patients or family members refused to participate in the study
  • Drug abuse or alcohol abuse
  • Other candidates who are judged to be not applicable to this study by doctors.

Trial locations and contacts

1 site in 1 country.

Lei Xin, Dr. contact

862131161365

aip_xin@163.com

China1 site

  • Changhai Hospital

    Shanghai, Shanghai Municipality, 200433

    Lei Xin, Dr., 862131161365, aip_xin@163.com

    Jianya Xue, Dr.

Other trials in China

About this study

Official title: Safety and Efficacy of Stem Cells From Human Exfoliated Deciduous Teeth for Treatment of Decompensated Liver Cirrhosis

This study is an prospective, randomized control study. Patients with decompensated cirrhosis will be randomly assigned to receive 4 times of SHED treatment plus standard medical care(treatment）or standard medical care (control). The primary outcome is MELD-Na score. Secondary outcomes are Child-Pugh, liver function, life quality and survival.

Read the detailed description

At present, there is still no effective treatment for liver cirrhosis, and the use of stem cells for the treatment of cirrhosis has caused great concern.Stem cells from human exfoliated deciduous teeth (SHED) has been shown to be safe and effective for liver diseases. Randomization controlled studies are needed to confirm the long term effect of SHED treatment for liver cirrhosis. The present study aimed to investigate the safety and efficacy of SHED in hepatitis B related liver cirrhosis patients.

This study is an prospective, randomized control study. Patients with decompensated cirrhosis will be randomly assigned to receive 4 times of SHED treatment plus standard medical care(treatment）or standard medical care (control). SHED infusion (1x10E6 cells/kg body weight) via peripheral vein will be given at week 0,4,8,12.The primary outcome is MELD-Na score. Secondary outcomes are Child-Pugh, liver function, life quality and survival.

Conditions
Liver Cirrhosis
Being tested
SHED group
Keywords
Liver Cirrhosis, stem cell, therapy
Medical subject headings
Liver Cirrhosis

What participants receive

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

  • SHED groupBiological

    1x10E6 MSCs/kg body weight will be administered via peripheral vein for 4 times at week 0,4,8,12

Study groups in NCT03957655
Study groupRoleWhat they receive
SHED groupExperimentalSHED transplantation via peripheral vein: 1x10E6 SHEDs/kg body weight administered via peripheral vein at week 0,4,8,12.
Receives: Biological: SHED group
ControlNo interventionStandard medication for viral hepatitis and cirrhosis

What is being measured

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

  1. Model for End-Stage Liver Disease (MELD)-Na score

    The MELD-Na score is a reliable measure of mortality risk in patients with end-stage liver disease.

    MELD-Na score=3.8ln[bilirubin (mg/dl)]+11.21ln(INR) +9.6ln[creatinine (mg/dl) +6.4* (cause: cholestasis and alcoholic cirrhosis are 0, others are 1) +1.59* (135-Na)

    Measured: baseline and 4,8,12,16,24 week

Secondary outcomes (4)

  1. Child-Pugh score

    The Child-Pugh score is a scoring system to measure the severity of chronic liver disease inclusive of cirrhosis. The point scores are added up and classified as: class A: 5-6 points class B: 7-9 points class C: 10-15 points

    The score is composed from several categories:

    total bilirubin, μmol/l (mg/dl)<34: 1 point 34-50: 2 points >50: 3 points

    serum albumin, g/l>35: 1 point 28-35: 2 points <28: 3 points

    INR<1.7: 1 point 1.7-2.3: 2 points >2.3: 3 points

    presence of ascites none: 1 point mild: 2 points moderate to severe: 3 points

    presence of hepatic encephalopathy none: 1 point grades I-II : 2 point grades III-IV: 3 point

    Measured: baseline and 4,8,12,16,24 week

  2. Changes of liver function

    Changes of liver function index such as ALT, AST, ALB, TBIL, PT

    Measured: baseline and 4,8,12,16,24 week

  3. Changes of life quality

    Changes of life quality as assessed by SF-36

    Measured: baseline and 4,8,12,16,24 week

  4. Survival Rate at half of one year

    Survival rate at half of one year

    Measured: half of one year

Timeline

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

  1. First posted21 May 2019
  2. Study start2 Dec 2019 (estimated)
  3. Primary completion31 Dec 2020 (estimated)
  4. Study completion31 Dec 2021 (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
Early Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03957655
Sponsor's protocol ID
SHED01
Status last verified
Dec 2019
First submitted
19 May 2019
Last updated
3 Dec 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Wang D, Zhang H, Liang J, Wang H, Hua B, Feng X, Gilkeson GS, Farge D, Shi S, Sun L. A Long-Term Follow-Up Study of Allogeneic Mesenchymal Stem/Stromal Cell Transplantation in Patients with Drug-Resistant Systemic Lupus Erythematosus. Stem Cell Reports. 2018 Mar 13;10(3):933-941. doi: 10.1016/j.stemcr.2018.01.029. Epub 2018 Mar 1.

    PubMed 29478901

  • Xuan K, Li B, Guo H, Sun W, Kou X, He X, Zhang Y, Sun J, Liu A, Liao L, Liu S, Liu W, Hu C, Shi S, Jin Y. Deciduous autologous tooth stem cells regenerate dental pulp after implantation into injured teeth. Sci Transl Med. 2018 Aug 22;10(455):eaaf3227. doi: 10.1126/scitranslmed.aaf3227.

    PubMed 30135248

  • Ohkoshi S, Hara H, Hirono H, Watanabe K, Hasegawa K. Regenerative medicine using dental pulp stem cells for liver diseases. World J Gastrointest Pharmacol Ther. 2017 Feb 6;8(1):1-6. doi: 10.4292/wjgpt.v8.i1.1.

    PubMed 28217369

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing SHED group in people with Liver Cirrhosis, run by Changhai 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 5 inclusion and 10 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 3 Dec 2019. 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?

Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.

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 Lei Xin, Dr. (862131161365, aip_xin@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Model for End-Stage Liver Disease (MELD)-Na score (time frame: baseline and 4,8,12,16,24 week). 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 NCT03957655, which also lists 3 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 3 Dec 2019.

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