3
项与 人脐带间充质干细胞 (拓华生物) 相关的临床试验评价人脐带间充质干细胞注射液在纤维化性间质性肺病患者中的安全性、耐受性和初步有效性的Ⅰ/Ⅱ期临床研究
主要目的：
Ⅰ期：评价人脐带间充质干细胞注射液在纤维化性间质性肺病患者中单次给药（SAD）的安全性和耐受性。
Ⅱa期：评价人脐带间充质干细胞注射液在纤维化性间质性肺病患者中多次给药（MAD）的安全性和耐受性。
Ⅱb期：首次给药后24周，用力肺活量（FVC）较基线的变化。
次要目的：
评价人脐带间充质干细胞注射液在纤维化性间质性肺病患者中的有效性。
评价人脐带间充质干细胞注射液在纤维化性间质性肺病患者中的安全性（仅Ⅱb期）。
A Phase I-II, Open-label, Single-arm, Dose-escalation Clinical Trial to Evaluate the Safety and Tolerability of Human Umbilical Cord Mesenchymal Stem Cell Injection in the Treatment of Moderate to Severe Acute Respiratory Distress Syndrome
Primary Objective: To evaluate the safety and tolerability of human umbilical cord mesenchymal stem cell injection in the treatment of moderate/severe acute respiratory distress syndrome.Secondary Objectives: To explore the efficacy and appropriate dosage of human umbilical cord mesenchymal stem cell injection in the treatment of moderate/severe acute respiratory distress syndrome.Exploratory Objective: To explore the immunogenicity and pharmacokinetic/pharmacodynamic (PK/PD) characteristics of a single dose of human umbilical cord mesenchymal stem cell injection in patients with moderate/severe acute respiratory distress syndrome.
A Phase I-II Clinical Study on the Safety, Tolerability, and Preliminary Efficacy of Human Umbilical Cord Mesenchymal Stem Cell Injection in Patients With Decompensated Hepatitis B Cirrhosis
Phase I (Single Administration, 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 to determine the safe clinical dose.Secondary Objective: To evaluate the preliminary efficacy of Human Umbilical Cord Mesenchymal Stem Cell Injection in patients with decompensated hepatitis B cirrhosis, providing a basis for the design of subsequent clinical trial protocols.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 Administrations, 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.
100 项与 人脐带间充质干细胞 (拓华生物) 相关的临床结果
100 项与 人脐带间充质干细胞 (拓华生物) 相关的转化医学
100 项与 人脐带间充质干细胞 (拓华生物) 相关的专利（医药）
1
项与 人脐带间充质干细胞 (拓华生物) 相关的新闻（医药）2026年4月15日，拓华生物科技有限公司自主研发并拥有自主知识产权的Ⅰ类创新药——人脐带间充质干细胞注射液（受理号：CXSL2600094），正式获得国家药品监督管理局药品审评中心（CDE）临床试验默示许可，获批开展Ⅰ-Ⅱ期临床试验，适应症为糖尿病肾脏病。
2型糖尿病肾病是糖尿病最常见的微血管并发症，也是导致终末期肾病的首要病因。当前临床常规治疗以血糖控制、血压管理、降低尿蛋白排泄为主，难以从根本上修复受损肾组织，无法有效阻断病程进展，临床亟需更具针对性的创新治疗方案。
人脐带间充质干细胞（hUC-MSCs）具备来源充足、伦理争议小、免疫原性低、增殖能力强等优势，是当前最适宜产业化应用的干细胞来源之一。该干细胞可通过多通路、多靶点协同发挥治疗作用，抑制肾脏炎症反应、调控免疫微环境，减轻肾小球及肾小管损伤；延缓肾脏纤维化进程，减少细胞外基质沉积，实现肾功能保护；同时可改善胰岛素抵抗、促进微血管修复，从代谢调节与组织修复双重维度延缓肾病发展，降低尿蛋白水平，稳定肾小球滤过率。
本次临床试验默示许可的获批，进一步夯实了公司在细胞治疗领域的研发布局，丰富了创新产品管线储备。随着细胞药物研发持续推进、更多适应症逐步获批，该产品不仅有望为广大糖尿病肾脏病患者带来全新的治疗方案，也将为企业高质量发展开辟新的增长空间。
100 项与 人脐带间充质干细胞 (拓华生物) 相关的药物交易
