Target- |
MechanismStem cell replacements |
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Inactive Indication- |
Drug Highest PhasePhase 1 |
First Approval Ctry. / Loc.- |
First Approval Date- |
IHS002人脐带间充质干细胞(IHS002HUC-MSC)治疗烧伤创面和慢性创面的I期临床试验
[Translation] Phase I clinical trial of IHS002 human umbilical cord mesenchymal stem cells (IHS002HUC-MSC) in the treatment of burn wounds and chronic wounds
主要目的:评价IHS002 HUC-MSC在烧伤创面和慢性创面(糖尿病足溃疡、压疮)患者中单次给药和多次给药的安全性和耐受性。
次要目的:1)初步探索IHS002 HUC-MSC给药剂量,初步评价IHS002 HUC-MSC促进创面愈合的有效性,为后续临床试验的给药剂量提供依据。2)评价IHS002 HUC-MSC的免疫原性。
探索性目的:初步探索IHS002 HUC-MSC局部给药的药代动力学。
[Translation] Primary objective: To evaluate the safety and tolerability of single and multiple administrations of IHS002 HUC-MSC in patients with burn wounds and chronic wounds (diabetic foot ulcers, pressure sores).
Secondary objectives: 1) To preliminarily explore the dosage of IHS002 HUC-MSC, preliminarily evaluate the effectiveness of IHS002 HUC-MSC in promoting wound healing, and provide a basis for the dosage of subsequent clinical trials. 2) To evaluate the immunogenicity of IHS002 HUC-MSC.
Exploratory objective: To preliminarily explore the pharmacokinetics of local administration of IHS002 HUC-MSC.
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