Clinical trial NCT03957655: Safety and Efficacy of SHED for Decompensated Liver Cirrhosis
Official title: Safety and Efficacy of Stem Cells From Human Exfoliated Deciduous Teeth for Treatment of Decompensated Liver Cirrhosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Liver Cirrhosis
Keywords: Liver Cirrhosis
stem cell
therapy
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
Collaborators: name: Eastern Hepatobiliary Surgery Hospital
name: CAR-T (Shanghai) Biotechnology Co., Ltd.
First posted: 2019-05-21
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Model for End-Stage Liver Disease (MELD)-Na score
timeFrame: baseline and 4,8,12,16,24 week
Secondary outcomes:
measure: Child-Pugh score
timeFrame: baseline and 4,8,12,16,24 week
measure: Changes of liver function
timeFrame: baseline and 4,8,12,16,24 week
measure: Changes of life quality
timeFrame: baseline and 4,8,12,16,24 week
measure: Survival Rate at half of one year
timeFrame: half of one year
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Changhai Hospital
state: Shanghai
Study officials:
affiliation: Changhai Hospital
name: Zhaoshen Li, Dr.
role: STUDY_CHAIR
affiliation: Changhai Hospital
name: Chengzhong Li, Dr.
role: STUDY_DIRECTOR
affiliation: Changhai Hospital
name: Lei Xin, Dr.
role: PRINCIPAL_INVESTIGATOR
affiliation: Changhai Hospital
name: Jianya Xue, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.