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).
Patients with severe alveolar bone resorption caused by inflammation, trauma, or other reasons, requiring bone grafting;
Aged 18 to 60 years;
No systemic diseases such as hypertension, diabetes, heart disease, or immunodeficiency;
Fully informed of the entire study process, willing to participate, and able to sign the informed consent form.
Patients without maxillofacial bone defects;
Patients with systemic diseases such as hypertension, heart disease, or diabetes;
Patients who have recently received immunosuppressive therapy;
Women who are planning pregnancy, pregnant, or breastfeeding;
Single group
Autologous bone marrow-derived mononuclear cells (BMMNCs)
Biological/VaccineApproximately 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
Other interventionBio-Oss xenogeneic bone graft material mixed with BMMNCs and implanted into the defect; the graft is covered with a collagen membrane.
New bone volume fraction in the grafted bone defect area measured by CBCT
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 intensity assessed by Visual Analog Scale (VAS)
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).
Number of participants reporting good comfort without foreign body sensation
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.
Number of participants with complications requiring clinical management
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.
Number of participants with abnormal mucosa at the implantation site
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.
Number of participants with implant exposure
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.
Number of participants with clinically significant abnormal laboratory safety tests
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.
Incidence and severity of adverse events
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.
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