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

2026년 9월 28일 업데이트: 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).

연구 개요

상태

모병

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (추정된)

20

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 장소

  • 중국
    • Jiangsu
      • Nanjing, Jiangsu, 중국, 210008
        • 모병
        • Nanjing Drum Tower Hospital, Nanjing University Medical School

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

16년 (어린이, 성인)

건강한 자원 봉사자를 받아들입니다

아니

연구 대상 성별

모두

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 해당 없음
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.
생물학적: 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.

다른 이름들:
  • BMMNC
다른: 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
New bone volume fraction in the grafted bone defect area measured by CBCT
기간: 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)

2차 결과 측정

결과 측정
측정값 설명
기간
Pain intensity assessed by Visual Analog Scale (VAS)
기간: 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
기간: 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
기간: 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

기타 결과 측정

결과 측정
측정값 설명
기간
Number of participants with abnormal mucosa at the implantation site
기간: 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
기간: 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
기간: 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
기간: 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

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

수사관

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

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2022년 11월 1일

기본 완료 (추정된)

2027년 1월 1일

연구 완료 (추정된)

2027년 9월 1일

연구 등록 날짜

최초 제출

2026년 9월 7일

QC 기준을 충족하는 최초 제출

2026년 9월 28일

처음 게시됨 (실제)

2026년 10월 1일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 10월 1일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 9월 28일

마지막으로 확인됨

2026년 8월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 2022-LCYJ-ZX-07

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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