NCT06539429进行中（未招募）1 期
Phase I Clinical Study to Evaluate Safety and Efficacy of ANT-301 in Knee Osteoarthritis Patients
Anterogen Co., Ltd.1 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2024年10月22日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Safety assessment
研究概览
简要总结
This is a phase I open study to evaluate the efficacy and safety of ANT-301 in patients with knee osteoarthritis K&L Grade III/IV.
详细描述
Study Design: open-label, single-center, dose-escalation study
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who have been provided with information about the clinical trial and have provided written consent on the informed consent form
- •Patients aged 19 to 70 years old.
- •Patients diagnosed with K&L grade III/IV knee osteoarthritis
- •Patients with a VAS pain score of 40mm or higher when measured on a 100-point scale
排除标准
- •Patients with joint diseases other than osteoarthritis
- •Patients who have undergone knee joint surgery or radiation therapy to the knee joint within 6 months prior to the screening
- •Patients who received intra-articular injections within 6 months prior to the screening
- •Patients who have received systemic steroid therapy within 3 months prior to the screening
- •Patients who have received immunosuppressive agents within 3 months prior to the screening
- •Patients who have received cell therapy or gene therapy to the target knee within 5 years prior to the screening
- •Patients who are unwilling to use contraception during the clinical trial period
研究组 & 干预措施
ANT-301
Experimental
Vial containing allogenic adipose-derived mesenchymal stem cells and human fibrin hydrogel
干预措施: ANT-301 (Biological)
结局指标
主要结局
Safety assessment
时间窗: Week 2, 4, 8, 12, 24 and Month 12
Number of Adverse events and Laboratory Abnormalities
次要结局
- WOMAC questionnaire score(Baseline, Week 4, 8, 12, 24 and 12 months)
- Pain improvement according to VAS scale measurements(Baseine, Week 4, 8, 12, 24 and Month 12)
- IKDC score(Baseline, Week 4, 8, 12, 24 and 12 months)
研究者
研究点 (1)
Loading locations...
相似试验
招募中
早期 1 期
Clinical Study of SN301A Injection in the Treatment of Hepatocellular CarcinomaHepatocellular Carcinoma (HCC)NCT06652243Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine12
招募中
1 期
CLDN6/GPC3/Mesothelin/AXL-CAR-NK Cell Therapy for Advanced Solid TumorsStage IV Ovarian CancerTestis Cancer, RefractoryEndometrial Cancer RecurrentCAR NKNCT05410717Second Affiliated Hospital of Guangzhou Medical University200
已完成
1 期
Multiple Ascending Doses (MAD) of Anti-A Disintegrin and Metalloproteinase With Thrombospondin Motifs-5 (Anti-ADAMTS-5) Nanobody in Participants With Knee Osteoarthritis (OA)Osteoarthritis, KneeNCT03583346Merck KGaA, Darmstadt, Germany32
招募中
1 期
A Clinical Research About CD70-targeted CAR-NKT Cells Therapy in Subjects with Advanced Malignant Solid TumorsAdvanced Malignant Solid TumorsNCT06728189Peking University Cancer Hospital & Institute13
招募中
1 期
CD70-targeted CAR-NKT Cells(CGC729) Therapy in the Renal Cell CarcinomaRenal Cell CarcinomaNCT06182735Fudan University9