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

Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School • ClinicalTrials.gov ID: NCT07852806

Registry updated: 2026-10-01

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Description

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).

Interventions

Autologous bone marrow-derived mononuclear cells (BMMNCs) (Biological)
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 (Other)
Bio-Oss xenogeneic bone graft material mixed with BMMNCs and implanted into the defect; the graft is covered with a collagen membrane.

Eligibility criteria

Inclusion Criteria: * 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. Exclusion Criteria: * 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; * Patients with allergic constitution or a history of allergy to drugs or food; * Patients with poor oral hygiene habits who cannot comply with medical advice, which may affect efficacy assessment; * Patients who have participated in other clinical trials within the past 4 weeks.

Conditions

Maxillofacial Bone Defect Alveolar Bone Loss

Locations

Nanjing Drum Tower Hospital, Nanjing University Medical School — Nanjing, Jiangsu, China

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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