Target- |
MechanismStem cell replacements |
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Inactive Indication- |
Drug Highest PhasePhase 1 |
First Approval Ctry. / Loc.- |
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Inactive Indication- |
Drug Highest PhasePreclinical |
First Approval Ctry. / Loc.- |
First Approval Date- |
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Mechanism- |
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Active Indication- |
Inactive Indication- |
Drug Highest PhaseDiscovery |
First Approval Ctry. / Loc.- |
First Approval Date- |
/ Enrolling by invitationPhase 1 An Exploratory Clinical Study to Evaluate UX-DA001 Injection (Human Midbrain Dopaminergic Progenitor Cells Injection) in Subjects with Idiopathic Parkinson's Disease
This clinical study is designed to explore the safety and tolerability of UX-DA001. It will also explore if UX-DA001 works to improve motor function in subjects with Parkinson's disease. UX-DA001 manufactured from participant's own cells will differentiate into mature dopaminergic neurons after being transplanted into the brain of the participant.
UX-DA001注射液(人中脑多巴胺能神经前体细胞注射液)在原发性帕金森病患者中的探索性临床试验
[Translation] UX-DA001 injection (human midbrain dopaminergic neural precursor cell injection) exploratory clinical trial in patients with primary Parkinson's disease
主要目的:评估不同剂量组 UX-DA001 注射液细胞移植治疗原发性帕金森病(PD)患者的安全性和耐受性。
次要目的:
评估不同剂量组 UX-DA001 注射液在原发性 PD 患者脑内的植入、存活和增生情况;
评估不同剂量组 UX-DA001 注射液对原发性 PD 患者运动症状的改善情况;
评估不同剂量组 UX-DA001 注射液对原发性 PD 患者非运动症状及整体生活质量的影响。
[Translation] Primary objective: To evaluate the safety and tolerability of cell transplantation of UX-DA001 injection in different dose groups for the treatment of patients with primary Parkinson's disease (PD).
Secondary objectives:
To evaluate the implantation, survival and proliferation of UX-DA001 injection in different dose groups in the brain of patients with primary PD;
To evaluate the improvement of motor symptoms of patients with primary PD by UX-DA001 injection in different dose groups;
To evaluate the effects of UX-DA001 injection in different dose groups on non-motor symptoms and overall quality of life of patients with primary PD.
100 Clinical Results associated with Shanghai Yuesai Biotechnology Co., Ltd.
0 Patents (Medical) associated with Shanghai Yuesai Biotechnology Co., Ltd.
100 Deals associated with Shanghai Yuesai Biotechnology Co., Ltd.
100 Translational Medicine associated with Shanghai Yuesai Biotechnology Co., Ltd.