Safety and Efficacy of SHED for Decompensated Liver Cirrhosis

NCT03957655 | Unknown Early Phase 1 DMC

• 1 other identifier: SHED01
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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. Secondary outcomes are Child-Pugh, liver function, life quality and survival.

Conditions

Liver Cirrhosis

Keywords

Liver Cirrhosis; stem cell; therapy

Outcome Measures

Primary Outcomes (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)

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

Secondary Outcomes (4)

• Child-Pugh score

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

• Changes of liver function

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

• Changes of life quality

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

• Survival Rate at half of one year

  half of one year

Study Arms (2)

SHED group

EXPERIMENTAL

SHED transplantation via peripheral vein: 1x10E6 SHEDs/kg body weight administered via peripheral vein at week 0,4,8,12.

Biological: SHED group

Control

NO INTERVENTION

Standard medication for viral hepatitis and cirrhosis

Interventions

SHED group BIOLOGICAL

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

SHED group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Changhai Hospital: lead
• Eastern Hepatobiliary Surgery Hospital: collaborator
• CAR-T (Shanghai) Biotechnology Co., Ltd.: collaborator

Study Sites (1)

Changhai Hospital

Shanghai, Shanghai Municipality, 200433, China

Location

Related Publications (3)

• 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.

  PMID: 29478901 BACKGROUND

• 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.

  PMID: 30135248 BACKGROUND

• 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.

  PMID: 28217369 BACKGROUND

MeSH Terms

Conditions

Liver Cirrhosis

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Zhaoshen Li, Dr.

  Changhai Hospital

  STUDY CHAIR

• Chengzhong Li, Dr.

  Changhai Hospital

  STUDY DIRECTOR

• Lei Xin, Dr.

  Changhai Hospital

  PRINCIPAL INVESTIGATOR

• Jianya Xue, Dr.

  Changhai Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lei Xin, Dr.

CONTACT

862131161365; aip_xin@163.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcome assessors will be blind to the randomization results of the participants.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: May 19, 2019
• First Posted: May 21, 2019
• Study Start: December 2, 2019
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2021
• Last Updated: December 3, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)