JPRN-jRCT2021200034已完成2 期
Investigator-initiated Phase 2 clinical study of S-005151 in patients with osteoarthritis of the knee
Ishibashi Yasuyuki0 个研究点目标入组 20 人开始时间: 2020年12月24日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 20
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 < 70age old（—）
- 性别
- All
入选标准
- •[At the time of informed consent]
- •1) Patients with the ability to understand the study and comply with such as the requirements of the study, and to obtain written consent prior to screening.
- •2) Male or female patients aged >=20 and <70 at the time of consent acquisition.
- •3) Patients with medial knee osteoarthritis scheduled for high tibial osteotomy and arthroscopic microfracture.
- •4) (Only women) Patients who can be consent to the contraceptive methods during the period from consent acquisition to 3 months after the last administration .
- •[Before surgery]
- •5) Patient with Medial knee osteoarthritis condition meeting the following for knee joints undergoing surgery.
- •-Kellgren-Lawrence grade is 2 or 3
- •-Exposure of subchondral bone is seen partially or the whole articular surface
- •-Area of the cartilage defect is 2 ~ 9 cm^2
- •-The mean of each subscale of Knee Injury and Osteoarthritis Outcome Score (KOOS) < 70
- •-Body Mass Index (BMI) <= 30 kg/m^2
- •[At Registration]
- •6) Patients undergoing surgery as specified in this study who are able to initiate drug administration by the day after surgery.
排除标准
- •[At the time of informed consent]
- •1) Patients with the following diseases in the knee joint of the surgical treatment side specified in this study.
- •A) Anterior cruciate ligament dysfunction, Posterior cruciate ligament dysfunction
- •B) Arthritis of the knee (purulent arthritis, gouty arthritis)
- •C) Lateral tibiofemoral arthropathy, patellofemoral arthropathy, and neuropathic arthropathy (Charcot's joint)
- •D) Medial femoral condyle osteonecrosis
- •E) Intra-articular fracture of the knee articular with residual sequelae during or after treatment
- •F) Fractures of the femur or tibia under treatment.
- •2) Patients with concomitant systemic inflammatory diseases (rheumatoid arthritis, psoriatic arthritis, various types of vasculitis).
- •3) Diabetics with poor control (HbA1C more than 8% in laboratory tests of pre-test 1).
- •4) Patients who cannot undergo MRI.
- •5) Patients with active malignancies (including a history of cancer within 5 years of disease-free period).
- •6) Patients with severe cardiovascular disease, renal disease, liver disease, respiratory disease, or hematologic disease.
- •7) Patients with a history of severe drug allergy (shock, anaphylaxis, angioedema) and patients with or with a history of severe allergic disease.
- •8) Female patients who wish to become pregnant during pregnancy or the study period, and female patients who are breastfeeding.
- •9) Patients who are scheduled to use prohibited concomitant medications or to receive prohibited concomitant therapy during the study period.
- •10) Patients who have received regenerative medicine in the past.
- •11) Patients who have previously received S-005151.
- •12) Patients who have received with other investigational products within 90 days prior to acquisition of consent.
- •13) Patients judged inappropriate for the study by the investigator or sub-investigator.
- •[Before surgery]
- •14) Patients requiring at least 15 degrees correction of the tibia alone for the knee joint performing the surgery.
- •15) Patients found to meet exclusion criteria 1) to 13).
- •[At Registration]
- •16) Patients found to meet exclusion criteria 1) to 14).
研究者
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