Defective Composite RestorationsNCT07066228
Bone Reconstruction With Autologous Bone Marrow Mesenchymal Stem Cells in Vitro to Repair Long Tubular Bone Defects
A study testing tissue-engineered bone in people with Defective Composite Restorations and Bone Cysts, run by The First Affiliated Hospital of Xinxiang Medical College at 1 site in China.
Trial summary
Commercial decalcified bone scaffolds were combined with autologous bone marrow mesenchymal stem cells to form tissue engineered bone in vitro to explore the effect of this tissue engineered bone in the clinical repair of long tubular bone defects in limbs. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Defective Composite Restorations, Bone Cysts, Bone Defect
- What is being tested?
- tissue-engineered bone
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 7 Aug 2025to Dec 2028
- 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 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age: 18-55 years old, gender unrestricted;
- Defective nonunion with bone loss exceeding 30% of the bone cross-section and a length of 2-3 cm;
- Solitary bone cysts involving more than 50% of the bone cross-section.
Who cannot join
- Combined with local tumors, tuberculosis, infections or other bone-healing affecting lesions;
- Systemic diseases affecting bone healing such as osteofibrous dysplasia, osteogenesis imperfecta, bone dystrophic diseases, and metabolic bone disorders;
- Moderate-to-severe osteoporosis (BMD: T-score < -2.5);
- Severe systemic conditions including systemic malnutrition, systemic infectious diseases, severe cardiopulmonary diseases, coagulation disorders, and major organ failure;
- Complicated with severe brain trauma;
- Heavy smoking, drug abuse, alcoholism, or other harmful addictions;
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- Psychiatric disorders or patients with menopausal symptoms;
- Concurrent participation in other studies or recent completion (within 4 weeks) of other clinical trials;
- Pregnancy, lactation, or planned pregnancy within one year after initial enrollment;
- Psychological conditions impairing treatment compliance;
- Congenital malformations of vital organs or other systems;
- Nonunion caused by malignant tumor resection;
- Refusal to accept tissue-engineered bone repair protocol.
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
The First Affiliated Hospital of Xinxiang Medical College
Xinxiang, Henan, 453000
Wenjie Ren, 13937354075, 13937354075@163.com
About this study
Official title: Clinical Transformation of Bone Reconstruction With Autologous Bone Marrow Mesenchymal Stem Cells in Vitro to Repair Long Tubular Bone Defects of Limbs
Commercial decalcified bone scaffolds were combined with autologous bone marrow mesenchymal stem cells to form tissue engineered bone in vitro to explore the effect of this tissue engineered bone in the clinical repair of long tubular bone defects in limbs.
Read the detailed description
Bone defects caused by trauma, tumors, and other factors, particularly weight-bearing long tubular bone defects in the limbs, pose significant harm to patients and severely impact their quality of life, remaining a major clinical challenge. Current repair methods such as autologous bone grafting, vascularized autologous bone grafting, allogeneic bone grafting, induced membrane technique, and bone transport technique face limitations including lengthy treatment cycles, high costs, restricted donor sites and bone harvest quantities, and unpredictable outcomes.
To address these challenges, the National Engineering Research Center for Tissue Engineering has developed an innovative approach through continuous research and innovation. This method utilizes autologous bone marrow mesenchymal stem cells (BMSCs) with minimal invasiveness, strong proliferation capacity, and potent osteogenic potential as seed cells for bone construction. These cells are combined with clinically approved allogeneic decalcified bone materials to create tissue-engineered bone through in vitro induction. This approach offers multiple advantages: absence of immune rejection, unrestricted material sources, sufficient cultured bone volume, and high survival rates, providing a new direction for treating long tubular bone defects in limbs.
This study aims to evaluate the clinical efficacy of tissue-engineered bone constructed with autologous BMSCs for repairing long bone defects in extremities, thereby providing evidence-based support for bone defect treatment.
- Being tested
- tissue-engineered bone
- Keywords
- autologous bone marrow mesenchymal stem cells, DBM, long tubular bone defects of limbs
- Medical subject headings
- Bone Cysts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tissue-engineered boneDevice
Commercial decalcified bone scaffolds were combined with autologous bone marrow mesenchymal stem cells to form tissue engineered bone in vitro
| Study group | Role | What they receive |
|---|---|---|
| Tissue engineered bone on bone defect | Other | Not described Receives: Device: tissue-engineered bone |
What is being measured
The primary outcome is the main question the study is designed to answer.
The scores of bone healing
The scores of bone healing are divided into three kinds: nonhealing: 0；delayed healing: 1; normal healing.
Measured: About 360 days after surgical treatment of bone defect
The adverse event incidence using tissue-engineered bone
The adverse event incidence of tissue-engineered bone
Measured: About 360 days after surgical treatment of bone defect
Bone union (bone healing) evaluation through modified lane and sandhu radiological scoring system
Evaluation of the bone regeneration in the area of intervention in comparison to baseline (V1), by means of X-ray and/or CT scan examination, on visits V1, V2 and V3. X-ray scoring systems have been implemented according to the criteria proposed by modified Lane and Sandhu Radiological Scoring System. This scoring system evaluates bone formation and union. To evaluate the bone formation, there is a scale with 5 points, from 0 to 4 (0=No evidence of bone formation-4=Bone formation occupying 100% of defect). To evaluate bone union, there is a scale with 3 points, from 0 to 2 (0=Non-union-2=Radiogrical union)
Measured: At the end of visits 1, 2, 3 (respectively performed at screening and 7, 90, 360 days after the surgery)
Secondary outcomes (2)
The scores of time of weight loading after operation
The scores of time of weight loading after operation are divided into three kinds: longer than six months: 0; longer than three months: 1; less than three months: 2
Measured: About 360 days after surgical treatment of bone defect
The scores of pain
The scores of pain after operation are divided into four kinds: severe: 0; moderate: 1; slight: 2; none: 3.
Measured: About 360 days after surgical treatment of bone defect
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2025
- Study start7 Aug 2025
- Primary completionJan 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Defective Composite RestorationsStudies of the same condition, open and under way.
- 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Xinxiang Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wenjie Ren, Principal investigator, The First Affiliated Hospital of Xinxiang Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07066228
- Sponsor's protocol ID
- TEBLTBD-2022-02
- Status last verified
- Dec 2025
- First submitted
- 11 Apr 2025
- Last updated
- 2 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Transformation of Bone Reconstruction With Autologous Bone Marrow Mesenchymal Stem Cells in Vitro to Repair Long Tubular Bone Defects of Limbs
- ClinicalTrials.gov ID
- NCT07066228
- Acronym / sponsor ID
- TEBLTBD-2022-02
- Keywords
- autologous bone marrow mesenchymal stem cells, DBM, long tubular bone defects of limbs
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Xinxiang Medical CollegeUniversity, hospital or other
- Study start
- 7 Aug 2025 (actual)
- Primary completion
- Jan 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 15 Jul 2025 (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.
Commercial decalcified bone scaffolds were combined with autologous bone marrow mesenchymal stem cells to form tissue engineered bone in vitro to explore the effect of this tissue engineered bone in the clinical repair of long tubular bone defects in limbs.
Detailed description
Bone defects caused by trauma, tumors, and other factors, particularly weight-bearing long tubular bone defects in the limbs, pose significant harm to patients and severely impact their quality of life, remaining a major clinical challenge. Current repair methods such as autologous bone grafting, vascularized autologous bone grafting, allogeneic bone grafting, induced membrane technique, and bone transport technique face limitations including lengthy treatment cycles, high costs, restricted donor sites and bone harvest quantities, and unpredictable outcomes.
To address these challenges, the National Engineering Research Center for Tissue Engineering has developed an innovative approach through continuous research and innovation. This method utilizes autologous bone marrow mesenchymal stem cells (BMSCs) with minimal invasiveness, strong proliferation capacity, and potent osteogenic potential as seed cells for bone construction. These cells are combined with clinically approved allogeneic decalcified bone materials to create tissue-engineered bone through in vitro induction. This approach offers multiple advantages: absence of immune rejection, unrestricted material sources, sufficient cultured bone volume, and high survival rates, providing a new direction for treating long tubular bone defects in limbs.
This study aims to evaluate the clinical efficacy of tissue-engineered bone constructed with autologous BMSCs for repairing long bone defects in extremities, thereby providing evidence-based support for bone defect treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tissue engineered bone on bone defect | Other | Device: tissue-engineered bone |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age: 18-55 years old, gender unrestricted;
- Defective nonunion with bone loss exceeding 30% of the bone cross-section and a length of 2-3 cm;
- Solitary bone cysts involving more than 50% of the bone cross-section.
Key exclusion criteria (13 listed)
- Combined with local tumors, tuberculosis, infections or other bone-healing affecting lesions;
- Systemic diseases affecting bone healing such as osteofibrous dysplasia, osteogenesis imperfecta, bone dystrophic diseases, and metabolic bone disorders;
- Moderate-to-severe osteoporosis (BMD: T-score < -2.5);
- Severe systemic conditions including systemic malnutrition, systemic infectious diseases, severe cardiopulmonary diseases, coagulation disorders, and major organ failure;
- Complicated with severe brain trauma;
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 |
|---|---|---|
| tissue-engineered boneCommercial decalcified bone scaffolds were combined with autologous bone marrow mesenchymal stem cells to form tissue engineered bone in vitro | Device | Tissue engineered bone on bone defect |
Primary outcome
The scores of bone healing
Time frame: About 360 days after surgical treatment of bone defect
The scores of bone healing are divided into three kinds: nonhealing: 0；delayed healing: 1; normal healing.
The adverse event incidence using tissue-engineered bone
Time frame: About 360 days after surgical treatment of bone defect
The adverse event incidence of tissue-engineered bone
Bone union (bone healing) evaluation through modified lane and sandhu radiological scoring system
Time frame: At the end of visits 1, 2, 3 (respectively performed at screening and 7, 90, 360 days after the surgery)
Evaluation of the bone regeneration in the area of intervention in comparison to baseline (V1), by means of X-ray and/or CT scan examination, on visits V1, V2 and V3. X-ray scoring systems have been implemented according to the criteria proposed by modified Lane and Sandhu Radiological Scoring System. This scoring system evaluates bone formation and union. To evaluate the bone formation, there is a scale with 5 points, from 0 to 4 (0=No evidence of bone formation-4=Bone formation occupying 100% of defect). To evaluate bone union, there is a scale with 3 points, from 0 to 2 (0=Non-union-2=Radiogrical union)
2 secondary outcomes
The scores of time of weight loading after operation
Time frame: About 360 days after surgical treatment of bone defect
The scores of pain
Time frame: About 360 days after surgical treatment of bone defect
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 2 Jan 2026.
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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.
Wenjie Ren principal investigator
The First Affiliated Hospital of Xinxiang Medical College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tissue-engineered bone in people with Defective Composite Restorations and Bone Cysts, run by The First Affiliated Hospital of Xinxiang Medical College 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 3 inclusion and 13 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 2 Jan 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 Wenjie Ren (8613937354075, 13937354075@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The scores of bone healing (time frame: About 360 days after surgical treatment of bone defect). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 Jan 2026.