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

NCT07852806 | Recruiting

• 1 other identifier: 2022-LCYJ-ZX-07
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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).

Conditions

Alveolar Bone Loss; Maxillofacial Bone Defect

Keywords

Bone marrow mononuclear cells; Bone regeneration; Bone defect; Stem cell therapy

Outcome Measures

Primary Outcomes (1)

• 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.

  Immediately after surgery, 3 months, and 6 months after surgery (primary assessment at 6 months)

Secondary Outcomes (3)

• Pain intensity assessed by Visual Analog Scale (VAS)

  Immediately after surgery, 1 week, 1 month, 3 months, and 6 months after surgery

• Number of participants reporting good comfort without foreign body sensation

  Up to 6 months after surgery

• Number of participants with complications requiring clinical management

  Up to 6 months after surgery

Other Outcomes (4)

• Number of participants with abnormal mucosa at the implantation site

  1 week, 1 month, 3 months, and 6 months after surgery

• Number of participants with implant exposure

  1 week, 1 month, 3 months, and 6 months after surgery

• Number of participants with clinically significant abnormal laboratory safety tests

  Preoperatively and at 1 week, 1 month, 3 months, and 6 months after surgery

Study Arms (1)

Autologous BMMNCs + Bio-Oss bone graft

EXPERIMENTAL

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.

Biological: Autologous bone marrow-derived mononuclear cells (BMMNCs); Other: Bio-Oss bone graft material with collagen membrane

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.

Also known as: BMMNCs

Autologous BMMNCs + Bio-Oss bone graft

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.

Autologous BMMNCs + Bio-Oss bone graft

Eligibility Criteria

• Age: 16 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School: lead

Study Sites (1)

Nanjing Drum Tower Hospital, Nanjing University Medical School

Nanjing, Jiangsu, 210008, China

RECRUITING

Related Publications (3)

• Kaigler D, Pagni G, Park CH, Braun TM, Holman LA, Yi E, Tarle SA, Bartel RL, Giannobile WV. Stem cell therapy for craniofacial bone regeneration: a randomized, controlled feasibility trial. Cell Transplant. 2013;22(5):767-77. doi: 10.3727/096368912X652968.

  PMID: 22776413 BACKGROUND

• Hibi H, Yamada Y, Ueda M, Endo Y. Alveolar cleft osteoplasty using tissue-engineered osteogenic material. Int J Oral Maxillofac Surg. 2006 Jun;35(6):551-5. doi: 10.1016/j.ijom.2005.12.007. Epub 2006 Apr 11.

  PMID: 16584868 BACKGROUND

• Roddy E, DeBaun MR, Daoud-Gray A, Yang YP, Gardner MJ. Treatment of critical-sized bone defects: clinical and tissue engineering perspectives. Eur J Orthop Surg Traumatol. 2018 Apr;28(3):351-362. doi: 10.1007/s00590-017-2063-0. Epub 2017 Oct 28.

  PMID: 29080923 BACKGROUND

MeSH Terms

Conditions

Alveolar Bone Loss

Condition Hierarchy (Ancestors)

Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Haiyan Qin, MD

  Nanjing Drum Tower Hospital, Nanjing University Medical School

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dongyu Bao

CONTACT

15651989007; baodongyu_anson@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 7, 2026
• First Posted: October 1, 2026
• Study Start: November 1, 2022
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: October 1, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)