Safety and Efficacy of SHED for Decompensated Liver Cirrhosis
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- 60
Summary
- Conditions
- Liver Cirrhosis
- Type
- Interventional
- Phase
- Early Phase 1
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Single (Outcomes Assessor)Masking Description: Outcome assessors will be blind to the randomization results of the participants.Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 70 years
- Gender
- Both males and females
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 studie...
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.
Tracking Information
- NCT #
- NCT03957655
- Collaborators
- Eastern Hepatobiliary Surgery Hospital
- CAR-T (Shanghai) Biotechnology Co., Ltd.
- Investigators
- Study Chair: Zhaoshen Li, Dr. Changhai Hospital Study Director: Chengzhong Li, Dr. Changhai Hospital Principal Investigator: Lei Xin, Dr. Changhai Hospital Principal Investigator: Jianya Xue, Dr. Changhai Hospital
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