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

28. September 2026 aktualisiert von: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

A Clinical Study of Autologous Bone Marrow Mononuclear Cells Combined With Bio-oss® for the Repair of Severe Maxillofacial Bone Defects

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).

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

Severe maxillofacial bone defects caused by trauma, tumor resection, congenital diseases (e.g., cleft lip and palate), or severe periodontitis-related alveolar bone resorption remain a major clinical challenge. Conventional bone grafting approaches (autologous bone, allogeneic bone, xenogeneic bone substitutes) have limitations including limited bone volume, additional donor-site morbidity, immune rejection, and unpredictable graft resorption.

Bone marrow-derived mononuclear cells (BMMNCs) contain hematopoietic stem cells, mesenchymal stem cells, and other progenitor populations with osteogenic and regenerative potential. Unlike mesenchymal stem cell-based approaches, BMMNCs can be used directly without in vitro expansion, shortening the treatment cycle and reducing cost and biosafety risks.

In this study, eligible patients will undergo the following procedure under local anesthesia: the mucoperiosteum at the defect site is incised and reflected, fibrous connective tissue is removed, and nourishing holes are prepared with a turbine drill. 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 in a GMP-grade cell preparation facility, with quality control testing. The freshly prepared BMMNCs are mixed with an appropriate amount of Bio-Oss bone graft material, implanted into the defect, covered with a collagen membrane, and the wound is sutured. Perioperative antibiotics are routinely used.

CBCT scans are obtained immediately after surgery and at 3 and 6 months to measure the new bone volume fraction in the grafted area. If bone formation is adequate at 6 months, dental implant placement may be performed in the edentulous area. Clinical symptoms and signs are assessed immediately after surgery and at 1 week, 1 month, 3 months, and 6 months. Laboratory safety tests (complete blood count, urinalysis, liver and kidney function, blood glucose) are performed preoperatively and at postoperative follow-up visits. Adverse events are recorded and graded according to CTCAE from enrollment to the end of the study.

Studientyp

Interventionell

Einschreibung (Geschätzt)

20

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210008
        • Rekrutierung
        • Nanjing Drum Tower Hospital, Nanjing University Medical School

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

16 Jahre bis 60 Jahre (Kind, Erwachsene)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: N / A
  • Interventionsmodell: Einzelgruppenzuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Autologous BMMNCs + Bio-Oss bone graft

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.
Biologisch: Autologous bone marrow-derived mononuclear cells (BMMNCs)

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.

Andere Namen:
  • BMMNCs
Sonstiges: Bio-Oss bone graft material with collagen membrane

Bio-Oss xenogeneic bone graft material mixed with BMMNCs and implanted into the defect; the graft is covered with a collagen membrane.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
New bone volume fraction in the grafted bone defect area measured by CBCT
Zeitfenster: Immediately after surgery, 3 months, and 6 months after surgery (primary assessment at 6 months)

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)

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Pain intensity assessed by Visual Analog Scale (VAS)
Zeitfenster: Immediately after surgery, 1 week, 1 month, 3 months, and 6 months after surgery

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).
Immediately after surgery, 1 week, 1 month, 3 months, and 6 months after surgery
Number of participants reporting good comfort without foreign body sensation
Zeitfenster: Up to 6 months after surgery

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.
Up to 6 months after surgery
Number of participants with complications requiring clinical management
Zeitfenster: Up to 6 months after surgery

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.
Up to 6 months after surgery

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Number of participants with abnormal mucosa at the implantation site
Zeitfenster: 1 week, 1 month, 3 months, and 6 months after surgery

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.
1 week, 1 month, 3 months, and 6 months after surgery
Number of participants with implant exposure
Zeitfenster: 1 week, 1 month, 3 months, and 6 months after surgery

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.
1 week, 1 month, 3 months, and 6 months after surgery
Number of participants with clinically significant abnormal laboratory safety tests
Zeitfenster: Preoperatively and at 1 week, 1 month, 3 months, and 6 months after surgery

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.
Preoperatively and at 1 week, 1 month, 3 months, and 6 months after surgery
Incidence and severity of adverse events
Zeitfenster: From enrollment to 6 months after surgery

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.
From enrollment to 6 months after surgery

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Ermittler

  • Hauptermittler: Haiyan Qin, MD, Nanjing Drum Tower Hospital, Nanjing University Medical School

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

Allgemeine Veröffentlichungen

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

1. November 2022

Primärer Abschluss (Geschätzt)

1. Januar 2027

Studienabschluss (Geschätzt)

1. September 2027

Studienanmeldedaten

Zuerst eingereicht

7. September 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

28. September 2026

Zuerst gepostet (Tatsächlich)

1. Oktober 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

1. Oktober 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

28. September 2026

Zuletzt verifiziert

1. August 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 2022-LCYJ-ZX-07

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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