Bone Marrow Mononuclear Cells for the Repair of Severe Maxillofacial Bone Defects

Patients receive transplantation of autologous bone marrow-derived mononuclear cells (BMMNCs) mixed with Bio-Oss bone graft material into the maxillofacial/alveolar bone defect, covered with a collagen membrane. Bone marrow (approximately 60 mL) is aspirated from the iliac crest; BMMNCs are isolated by density-gradient centrifugation without in vitro expansion.

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.

• 骨髓基质细胞

Bio-Oss xenogeneic bone graft material mixed with BMMNCs and implanted into the defect; the graft is covered with a collagen membrane.

The volume fraction of newly formed bone in the grafted defect area, measured and analyzed on cone-beam computed tomography (CBCT) images and reported as a percentage of new bone volume relative to the total grafted defect volume.

Pain at the surgical site assessed using the Visual Analog Scale (VAS), a 0-10 scale where 0 = no pain and 10 = worst imaginable pain. Higher scores indicate a worse outcome (more pain).

Patient self-reported comfort and absence of foreign body sensation, assessed by patient interview at each follow-up visit. Reported as the number of participants reporting good comfort.

Occurrence of persistent or irreversible symptoms and complications/comorbidities requiring clinical management, assessed at each follow-up visit. Reported as the number of participants with such events.

Clinical examination of the color, shape, and texture of the mucosa at the implantation site, documented by photography. Reported as the number of participants with any abnormal mucosal finding.

Exposure of the implanted graft material at the implantation site, assessed by clinical examination and documented by photography. Reported as the number of participants with implant exposure.

Laboratory safety assessments include complete blood count, urinalysis, liver and kidney function, and blood glucose. Results will be aggregated and reported as the number of participants with any clinically significant laboratory abnormality.

All adverse events recorded from enrollment to end of study, graded according to the Common Terminology Criteria for Adverse Events (CTCAE) on a 5-grade scale: Grade 1 = mild, Grade 2 = moderate, Grade 3 = severe, Grade 4 = life-threatening or disabling, Grade 5 = death. Higher grades indicate a worse outcome. Reported as the number of participants with adverse events.