Bone marrow cells plus Bio-Oss graft for repairing severe jawbone defects

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-center, single-arm, open-label study conducted at Nanjing Drum Tower Hospital to assess the safety and potential benefit of autologous bone marrow–derived mononuclear cells combined with Bio-Oss bone graft for repairing severe alveolar/jaw bone loss. About 20 eligible adults will undergo 60 mL of autologous bone marrow aspiration, isolation of BMMNCs without expansion, and implantation with Bio-Oss covered by a collagen membrane, followed by postoperative imaging and scheduled follow-ups. Outcomes will include imaging-based assessment of new bone formation and monitoring for adverse events over the follow-up period. The approach aims to shorten treatment timelines and reduce biosafety risks by avoiding in vitro cell expansion.

Why it matters

Who can join: the full rules

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.

Where it's running

• Nanjing Drum Tower Hospital, Nanjing University Medical School
  Nanjing, Jiangsu, China Recruiting

Study contacts

• Principal investigator: Haiyan Qin, MD — Nanjing Drum Tower Hospital, Nanjing University Medical School
• Study coordinator: Dongyu Bao
• Email: baodongyu_anson@163.com
• Phone: 15651989007

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.