Maxillofacial Bone DefectNCT07852806
Bone Marrow Mononuclear Cells for the Repair of Severe Maxillofacial Bone Defects
A study testing Autologous bone marrow-derived mononuclear cells (BMMNCs) and Bio-Oss bone graft material with collagen membrane in people with Maxillofacial Bone Defect and Alveolar Bone Loss, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 to 60 years
- Conditions the study is for
- Maxillofacial Bone Defect, Alveolar Bone Loss
- What is being tested?
- Autologous bone marrow-derived mononuclear cells (BMMNCs) and Bio-Oss bone graft material with collagen membrane
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2022to 1 Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Nanjing Drum Tower Hospital, Nanjing University Medical School
Nanjing, Jiangsu, 210008
About this study
Official title: 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).
Read the detailed description
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.
- Conditions
- Maxillofacial Bone Defect, Alveolar Bone Loss
- Being tested
- Autologous bone marrow-derived mononuclear cells (BMMNCs), Bio-Oss bone graft material with collagen membrane
- Keywords
- Bone marrow mononuclear cells, Bone regeneration, Bone defect, Stem cell therapy
- Medical subject headings
- Alveolar Bone Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous bone marrow-derived mononuclear cells (BMMNCs)Biological
Also called 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.
Bio-Oss bone graft material with collagen membraneOther
Bio-Oss xenogeneic bone graft material mixed with BMMNCs and implanted into the defect; the graft is covered with a collagen membrane.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: Autologous bone marrow-derived mononuclear cells (BMMNCs); Other: Bio-Oss bone graft material with collagen membrane |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
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).
Measured: Immediately after surgery, 1 week, 1 month, 3 months, and 6 months after surgery
Number of participants reporting good comfort without foreign body sensation
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.
Measured: Up to 6 months after surgery
Number of participants with complications requiring clinical management
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.
Measured: Up to 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2026
- Study start1 Nov 2022
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Maxillofacial Bone DefectStudies of the same condition, open and under way.
- More trials run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Haiyan Qin, MD, Principal investigator, Nanjing Drum Tower Hospital, Nanjing University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07852806
- Sponsor's protocol ID
- 2022-LCYJ-ZX-07
- Status last verified
- Aug 2026
- First submitted
- 7 Sep 2026
- Last updated
- 1 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 22776413Hibi 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.
PubMed 16584868Roddy 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.
PubMed 29080923
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study of Autologous Bone Marrow Mononuclear Cells Combined With Bio-oss® for the Repair of Severe Maxillofacial Bone Defects
- ClinicalTrials.gov ID
- NCT07852806
- Acronym / sponsor ID
- 2022-LCYJ-ZX-07
- Conditions
- Maxillofacial Bone Defect, Alveolar Bone Loss
- Keywords
- Bone marrow mononuclear cells, Bone regeneration, Bone defect, Stem cell therapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Sep 2027 (estimated)
- First posted
- 1 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Autologous BMMNCs + Bio-Oss bone graft | Experimental | Biological: Autologous bone marrow-derived mononuclear cells (BMMNCs), Other: Bio-Oss bone graft material with collagen membranePatients 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. |
Who may qualify
- Ages
- 16 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autologous bone marrow-derived mononuclear cells (BMMNCs)Also: BMMNCsApproximately 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. | Biological | Autologous BMMNCs + Bio-Oss bone graft |
| Bio-Oss bone graft material with collagen membraneBio-Oss xenogeneic bone graft material mixed with BMMNCs and implanted into the defect; the graft is covered with a collagen membrane. | Other | Autologous BMMNCs + Bio-Oss bone graft |
Primary outcome
New bone volume fraction in the grafted bone defect area measured by CBCT
Time frame: 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.
3 secondary outcomes
Pain intensity assessed by Visual Analog Scale (VAS)
Time frame: Immediately after surgery, 1 week, 1 month, 3 months, and 6 months after surgery
Number of participants reporting good comfort without foreign body sensation
Time frame: Up to 6 months after surgery
Number of participants with complications requiring clinical management
Time frame: Up to 6 months after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2026.
- Background: PubMed 22776413Kaigler 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.
- Background: PubMed 16584868Hibi 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.
- Background: PubMed 29080923Roddy 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.
- Individual participant dataSharing planned: No
Related trials for Maxillofacial Bone Defect
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Haiyan Qin, MD principal investigator
Nanjing Drum Tower Hospital, Nanjing University Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Autologous bone marrow-derived mononuclear cells (BMMNCs) and Bio-Oss bone graft material with collagen membrane in people with Maxillofacial Bone Defect and Alveolar Bone Loss, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dongyu Bao (15651989007, baodongyu_anson@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
New bone volume fraction in the grafted bone defect area measured by CBCT (time frame: Immediately after surgery, 3 months, and 6 months after surgery (primary assessment at 6 months)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07852806, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2026.