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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.

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	lumbar stenosis, spondylolisthesis, spondylolysis, scoliosis, instability, disc disease
Date of first enrollment	16/12/2025
Target sample size	36
Countries of recruitment
Study type	Interventional
Intervention(s)	The investigational medicinal product is an osteogenic agent in which the modified human recombinant bone morphogenetic protein AMP2 is bound to the absorbable bone regeneration material ReBOSSIS-J. Trial interventions other than the investigational medicinal product may include the use of spinal cages as medical devices corresponding to the investigational device for the fixation of RBBM-S1, provided that such medical devices are not manufactured by ORTHOREBIRTH Co., Ltd. and are not manufactured by a third party for ORTHOREBIRTH Co., Ltd.

Outcome(s)

Primary Outcome

Bone fusion assessed by CT at 52 weeks postoperatively

Secondary Outcome

1. Bone fusion assessed by CT at 26 weeks postoperatively. 2. Bone fusion assessed by radiography at 26, 39, and 52 weeks postoperatively. 3. Change from baseline in NRS scores for low back pain and lower extremity pain due to degenerative lumbar disease at 12, 26, 39, and 52 weeks postoperatively. 4. Change from baseline in ODI at 12, 26, 39, and 52 weeks postoperatively. 5. Change from baseline in JOABPEQ at 12, 26, 39, and 52 weeks postoperatively. 6. Change from baseline in EQ-5D-5L at 12, 26, 39, and 52 weeks postoperatively. 7. Presence or absence of secondary surgical interventions due to nonunion or pseudoarthrosis up to week 52. Safety evaluation: Adverse events Pharmacokinetic assessment of AMP2 CT imaging assessments at 2, 6, 12, 26, and 52 weeks postoperatively Radiographic assessments at 2, 6, 12, 26, 39, and 52 weeks postoperatively

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	Not applicable
Gender
Include criteria	1. Japanese patients aged 18 years or older at the time of informed consent, with fully matured skeletal development. 2. 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. 3. Patients whose general medical condition is stable and who are eligible for surgical intervention. 4. Male patients or female patients who are postmenopausal (including menopause due to oophorectomy). 5. Patients who have received a sufficient explanation of the study and have provided written informed consent.
Exclude criteria	1. Patients requiring surgery at more than one intervertebral level. 2. 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. 3. 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. 4. Patients with a BMI of 40 or higher. 5. 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. 6. Patients with an active systemic infection or an infection at the planned surgical site. 7. Patients with a history of smoking (including electronic cigarettes and nicotine-containing products) within 30 days prior to surgery. 8. 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. 9. Patients with diabetes mellitus whose glycemic control is inadequate. 10. Patients with endocrine or metabolic disorders known to affect bone metabolism. 11. Patients who have received any of the following medications that may affect bone healing within four weeks prior to surgery: 11-1. Bone-forming agents (PTH analogues) 11-2. Anti-sclerostin monoclonal antibodies 11-3. Systemic corticosteroids or corticosteroid-containing products 11-4. Immunosuppressive agents 12. Patients with a history of hypersensitivity or allergy to the investigational product or medical devices used in the study. 13. Patients who are unable to practice appropriate contraception during the study period. 14. Patients with prior exposure to recombinant proteins or peptides used for bone formation. 15. Patients who have participated in another clinical study within one year prior to investigational product administration. 16. Patients deemed unsuitable for participation in this study by the principal investigator or sub-investigator.