NCT05155657

Study of Decompensated Alcoholic Cirrhosis Treatment by Stem Cells

A Pilot Clinical Study to Evaluate Safety, Tolerability and Preliminary Efficacy of Intravenous Infusion of Umbilical Cord Mesenchymal Stem Cell in the Treatment of Decompensated Alcoholic Cirrhosis

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Yantai Yuhuangding Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

The main purpose of this study is to evaluate the safety and tolerance of umbilical cord mesenchymal stem cells (UCMSCs) in patients with decompensated alcoholic cirrhosis, and to provide dose basis for subsequent clinical study design. We will also explore the possible mechanism of UCMSCs in the treatment of decompensated alcoholic cirrhosis (DAC).

Detailed description

This study adopted a single-center, single-arm, single-dose combined multiple-dose administration, and dose-escalation clinical trial design to evaluate the safety, tolerability and preliminary effectiveness of UCMSCs in the treatment of patients with decompensated liver cirrhosis. Patients were recruited into three different dose groups, and 12 subjects were enrolled in each group. The subjects of each group will receive 0.5×10\^6 cells/kg, 1.0×10\^6 cells/kg, and 2.0×10\^6 cells/kg respectively. According to the principle of dose escalation, subjects preset to low-dose will receive the administration first. Each group will receive only one corresponding dose for safety and tolerability check. The subjects will be observed for 21 days after the initial dose due to limited proliferation or differentiation potential and relatively low immunogenicity of mesenchymal stem cell products. The safety measures will be discussed by the Data Safety and Monitoring Board (DSMB) to determine whether subjects who have received a single dose will proceed with subsequent injections. Once all subjects in the lower-dose group have completed the initial administration and observed for 21 days. The DSMB will decided whether to proceed with the next-dose group. All subjects will receive routine drug treatment during the study. Primary endpoint: incidence and severity of cell therapy related adverse events from the beginning of treatment to the end of the follow-up. Secondary end point of the study includes: the change in Model For End-Stage Liver Disease (MELD) score of the subjects from baseline, at 1, 3, 6 and 12 months after the last administration; the overall survival rate at the 12th month after the last administration; Changes in liver function compared with baseline at 1, 3, 6 and 12 months after the last administration; changes of child Pugh score compared with baseline at 1, 3, 6 and 12 months after the last administration; and the change of Karnofsky Performance Status Scale (KPS) score from baseline at 1, 3, 6 and 12 months after the last administration.

Conditions

• Alcoholic Cirrhosis

Interventions

Type	Name	Description
BIOLOGICAL	Conventional therapy plus low dose UCMSCs treatment	Patients will receive the conventional therapy plus low dose UCMSCs treatment (0.5×10\^6 UCMSCs/kg body)
BIOLOGICAL	Conventional therapy plus medium dose UCMSCs treatment	Patients will receive conventional therapy plus medium dose UCMSCs treatment (1×10\^6 UCMSCs/kg body)
BIOLOGICAL	Conventional therapy plus high dose UCMSCs treatment	Patients will receive conventional therapy plus high dose UCMSCs treatment (2×10\^6 UCMSCs/kg body)

Timeline

• Start date: 2022-06-13
• Primary completion: 2024-12-25
• Completion: 2024-12-25
• First posted: 2021-12-13
• Last updated: 2023-03-28

Locations

1 site across 1 country: China