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.
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.
Tokuyama Ryusuke
ORTHOREBIRTH CO. LTD.
15-3-303 Chigasaki-Chuo, Tsuzuki-ku, Yokohama, Kanagawa, Japan 224-0032
+81-45-532-3650
tokuyama@orthorebirth.com
Tokuyama Ryusuke
ORTHOREBIRTH CO. LTD.
15-3-303 Chigasaki-Chuo, Tsuzuki-ku, Yokohama, Kanagawa, Japan 224-0032
+81-45-532-3650
tokuyama@orthorebirth.com
Recruiting
Dec. 16, 2025
36
Interventional
randomized controlled trial
open(masking not used)
no treatment control/standard of care control
parallel assignment
treatment purpose
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.
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.
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.
Bone fusion assessed by CT at 52 weeks postoperatively
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
