Human Cord Derived MSC (Jilin Tuohua )

Phase I (single dose, randomized, double-blind, dose escalation) Primary objective: To evaluate the safety and tolerability of human umbilical cord mesenchymal stem cell injection in patients with decompensated hepatitis B cirrhosis and determine the safe dose for clinical use. Secondary objective: To evaluate the preliminary efficacy of human umbilical cord mesenchymal stem cell injection in patients with decompensated hepatitis B cirrhosis and provide a basis for the design of subsequent clinical trial programs. Exploratory objective: To evaluate the pharmacokinetic characteristics and immunogenicity of human umbilical cord mesenchymal stem cell injection in patients with decompensated hepatitis B cirrhosis. Phase II (multiple doses, randomized, double-blind, dose expansion) Primary objective: To evaluate the preliminary efficacy of human umbilical cord mesenchymal stem cell injection in patients with decompensated hepatitis B cirrhosis. Secondary objective: To evaluate the safety of human umbilical cord mesenchymal stem cell injection in patients with decompensated hepatitis B cirrhosis. Exploratory objective: To evaluate the pharmacokinetic characteristics and immunogenicity of human umbilical cord mesenchymal stem cell injection in patients with decompensated hepatitis B cirrhosis.

Primary Objectives: Phase I: To evaluate the safety and tolerability of a single dose (SAD) of human umbilical cord mesenchymal stem cell injection in patients with fibrotic interstitial lung disease. Phase IIa: To evaluate the safety and tolerability of multiple doses (MAD) of human umbilical cord mesenchymal stem cell injection in patients with fibrotic interstitial lung disease. Phase IIb: To evaluate the change from baseline in forced vital capacity (FVC) 24 weeks after the first dose. Secondary Objectives: To evaluate the efficacy of human umbilical cord mesenchymal stem cell injection in patients with fibrotic interstitial lung disease. To evaluate the safety of human umbilical cord mesenchymal stem cell injection in patients with fibrotic interstitial lung disease (Phase IIb only).