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

RecruitingNAAges 16 Years - 60 YearsAllThe Affiliated Nanjing Drum Tower Hospital of Nan…
NCT07852806 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 postoperat

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📋 Eligibility rules (as published)
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.
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What it tests

  • Autologous bone marrow-derived mononuclear cells (BMMNCs)
  • Bio-Oss bone graft material with collagen membrane
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Where

1 site
Nanjing Drum Tower Hospital, Nanjing University Medical School
Nanjing, China
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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