Safety and Efficacy of SHED for Decompensated Liver Cirrhosis

Overview

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.

Full Title of Study: “Safety and Efficacy of Stem Cells From Human Exfoliated Deciduous Teeth for Treatment of Decompensated Liver Cirrhosis”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: December 31, 2020

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.

Interventions

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

Arms, Groups and Cohorts

  • Experimental: SHED group
    • SHED transplantation via peripheral vein: 1x10E6 SHEDs/kg body weight administered via peripheral vein at week 0,4,8,12.
  • No Intervention: Control
    • Standard medication for viral hepatitis and cirrhosis

Clinical Trial Outcome Measures

Primary Measures

  • Model for End-Stage Liver Disease (MELD)-Na score
    • Time Frame: baseline and 4,8,12,16,24 week
    • 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)

Secondary Measures

  • Child-Pugh score
    • Time Frame: baseline and 4,8,12,16,24 week
    • 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
  • Changes of liver function
    • Time Frame: baseline and 4,8,12,16,24 week
    • Changes of liver function index such as ALT, AST, ALB, TBIL, PT
  • Changes of life quality
    • Time Frame: baseline and 4,8,12,16,24 week
    • Changes of life quality as assessed by SF-36
  • Survival Rate at half of one year
    • Time Frame: half of one year
    • Survival rate at half of one year

Participating in This Clinical Trial

Inclusion Criteria

1. Aged 18-70 years 2. HBV-related liver cirrhosis with presentations of decompensation 3. Antiviral treatment with nucleotide drugs for more than half a year and HBV DNA is less than the minimum detection limit; 4. Child-Pugh score B and MELD-Na score≤25 5. Written consent Exclusion Criteria:

1. Hepatic encephalopathy, hepatorenal syndrome, acute phase of severe hepatitis 2. Child-Pugh score A or C 3. Hepatocellular carcinoma or other malignancies 4. Cirrhosis or liver failure caused by non-Hepatitis B 5. Pregnancy or breastfeeding 6. Severe bacteria infection,coinfection with HIV or other viral hepatitis. 7. History of severe allergy to biological products or history of immunization within half a year 8. Patients or family members refused to participate in the study 9. Drug abuse or alcohol abuse 10. Other candidates who are judged to be not applicable to this study by doctors.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Changhai Hospital
  • Collaborator
    • Eastern Hepatobiliary Surgery Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Zhaoshen Li, Prof. – Changhai Hospital
  • Overall Official(s)
    • Zhaoshen Li, Dr., Study Chair, Changhai Hospital
    • Chengzhong Li, Dr., Study Director, Changhai Hospital
    • Lei Xin, Dr., Principal Investigator, Changhai Hospital
    • Jianya Xue, Dr., Principal Investigator, Changhai Hospital
  • Overall Contact(s)
    • Lei Xin, Dr., 862131161365, aip_xin@163.com

References

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.

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.

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.

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