A Phase I/II exploratory clinical trial to evaluate the efficacy and safety of RBBM-S1 in patients requiring lumbar interbody fusion for degenerative lumbar disease, in comparison with the standard treatment of autologous bone grafting.

未提供0 个研究点目标入组 36 人开始时间: 待定

适应症

试验速览

阶段: 不适用
状态: 招募中
入组人数: 36

研究概览研究设计入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional
分配方式: Randomized

入排标准

年龄范围: 18age old over 至 No limit（—）

入选标准

•Japanese patients aged 18 years or older at the time of informed consent, with fully matured skeletal development.
•Patients for whom single-level lumbar interbody fusion is indicated due to lumbar spinal canal stenosis, degenerative spondylolisthesis, lumbar spondylolysis/spondylolisthesis, degenerative lumbar scoliosis, lumbar instability, or lumbar disc disease.
•Patients whose general medical condition is stable and who are eligible for surgical intervention.
•Male patients or female patients who are postmenopausal (including menopause due to oophorectomy).
•Patients who have received a sufficient explanation of the study and have provided written informed consent.

排除标准

•Patients requiring surgery at more than one intervertebral level.
•Patients with a history of lumbar fusion surgery (including decompression with fusion) at the affected level; however, patients with a history of decompression alone are not excluded.
•Patients whose bone mineral density (BMD) by DEXA is less than 70% of the young adult mean (YAM), or patients with osteoporosis for whom lumbar fusion surgery is judged to be contraindicated at the investigator's discretion.
•Patients with a BMI of 40 or higher.
•Patients with an existing malignant tumor, or those who have received radiotherapy or chemotherapy for a malignant tumor within the past five years from the time of informed consent. Patients who underwent tumor resection alone, or those who received only hormonal therapy as postoperative adjuvant therapy, are not excluded.
•Patients with an active systemic infection or an infection at the planned surgical site.
•Patients with a history of smoking (including electronic cigarettes and nicotine-containing products) within 30 days prior to surgery.
•Patients with systemic diseases such as lupus, Reiter's disease, rheumatic disorders, or autoimmune diseases requiring immunosuppressive therapy including biologics, or other systemic inflammatory conditions.
•Patients with diabetes mellitus whose glycemic control is inadequate.
•Patients with endocrine or metabolic disorders known to affect bone metabolism.
•Patients who have received any of the following medications that may affect bone healing within four weeks prior to surgery:
•Bone-forming agents (PTH analogues)
•Anti-sclerostin monoclonal antibodies
•Systemic corticosteroids or corticosteroid-containing products
•Immunosuppressive agents
•Patients with a history of hypersensitivity or allergy to the investigational product or medical devices used in the study.
•Patients who are unable to practice appropriate contraception during the study period.
•Patients with prior exposure to recombinant proteins or peptides used for bone formation.
•Patients who have participated in another clinical study within one year prior to investigational product administration.
•Patients deemed unsuitable for participation in this study by the principal investigator or sub-investigator.

研究者

发起方

未提供

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