Clinical Research Directory
Browse clinical research sites, groups, and studies.
Bone Marrow Mononuclear Cells for the Repair of Severe Maxillofacial Bone Defects
Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Summary
This is a single-center, single-arm, open-label clinical study conducted at the Department of Stomatology, Nanjing Drum Tower Hospital. The study aims to evaluate the safety and efficacy of autologous bone marrow-derived mononuclear cells (BMMNCs) combined with a bone graft material (Bio-Oss) for the repair of severe maxillofacial (alveolar/jaw) bone defects caused by inflammation, trauma, or other reasons. Approximately 20 patients aged 18-60 years with severe alveolar bone resorption requiring bone grafting will be enrolled. About 60 mL of autologous bone marrow will be aspirated from the iliac crest, and BMMNCs will be isolated by density-gradient centrifugation under GMP conditions without in vitro expansion. The BMMNCs will be mixed with Bio-Oss bone graft material and implanted into the bone defect, covered with a collagen membrane. Cone-beam CT (CBCT) will be performed postoperatively to assess new bone formation. Follow-up visits are scheduled at 1 week, 1 month, 3 months, and 6 months after surgery. The primary outcome is the new bone volume fraction in the grafted area measured by CBCT. Safety will be assessed by clinical examination of the implantation site and laboratory tests (blood routine, urinalysis, liver and kidney function, blood glucose).
Official title: A Clinical Study of Autologous Bone Marrow Mononuclear Cells Combined With Bio-oss® for the Repair of Severe Maxillofacial Bone Defects
Key Details
Gender
All
Age Range
16 Years - 60 Years
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2022-11-01
Completion Date
2027-09-01
Last Updated
2026-10-01
Healthy Volunteers
No
Interventions
Autologous bone marrow-derived mononuclear cells (BMMNCs)
Approximately 60 mL of autologous bone marrow is aspirated from the iliac crest. BMMNCs are isolated using human peripheral blood lymphocyte separation medium by density-gradient centrifugation under GMP conditions, with quality control testing, and used fresh without in vitro expansion. The BMMNCs are mixed with an appropriate amount of Bio-Oss bone graft material and implanted into the bone defect during surgery under local anesthesia, covered with a collagen membrane. Perioperative antibiotics are routinely administered.
Bio-Oss bone graft material with collagen membrane
Bio-Oss xenogeneic bone graft material mixed with BMMNCs and implanted into the defect; the graft is covered with a collagen membrane.
Locations (1)
Nanjing Drum Tower Hospital, Nanjing University Medical School
Nanjing, Jiangsu, China