[Translation] A clinical study on the safety, tolerability and preliminary efficacy of local injection of human adipose-derived mesenchymal stem cell injection for hand skin lesions in systemic sclerosis
主要目的
观察人脂肪间充质干细胞注射液局部注射用于治疗系统性硬化症手部皮肤病变的安全性和耐受性。
次要目的
观察人脂肪间充质干细胞注射液局部注射用于治疗系统性硬化症手部皮肤病变的初步有效性。
探索性目的
(1) 探索人脂肪间充质干细胞注射液局部注射用于治疗系统性硬化症手部皮肤病变的肺部相关指标的变化;
(2) 探索人脂肪间充质干细胞注射液局部注射用于治疗系统性硬化症时手部改良的Rodnan皮肤厚度积分(mRSS)较基线的变化情况。
[Translation] Primary objective
To observe the safety and tolerability of local injection of human adipose-derived mesenchymal stem cell injection for the treatment of hand skin lesions in systemic sclerosis.
Secondary objective
To observe the preliminary efficacy of local injection of human adipose-derived mesenchymal stem cell injection for the treatment of hand skin lesions in systemic sclerosis.
Exploratory objective
(1) To explore the changes in lung-related indicators in the treatment of hand skin lesions in systemic sclerosis after local injection of human adipose-derived mesenchymal stem cell injection;
(2) To explore the changes in the modified Rodnan skin thickness score (mRSS) of the hand compared with the baseline when local injection of human adipose-derived mesenchymal stem cell injection is used to treat systemic sclerosis.