An interventional study of tissue-engineered bone in Defective Composite Restorations, Bone Cysts and Bone Defect, sponsored by The First Affiliated Hospital of Xinxiang Medical College. Recruiting at 1 site in China. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2026-01-02.
Sponsored by The First Affiliated Hospital of Xinxiang Medical College · Not applicable, Interventional, and Treatment
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.
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.
18 studies on the registry are indexed under Bone Cysts; 5 are open to participants now.
This study's planned enrollment of 30 is above the median of 17 across 10 interventional studies indexed under Bone Cysts.
Browse Bone Cysts studies →The First Affiliated Hospital of Xinxiang Medical College is the lead sponsor of 42 studies on the registry; 38 are open to participants now.
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Exclusion Criteria:
Device: tissue-engineered bone
Commercial decalcified bone scaffolds were combined with autologous bone marrow mesenchymal stem cells to form tissue engineered bone in vitro
The scores of bone healing
The scores of bone healing are divided into three kinds: nonhealing: 0；delayed healing: 1; normal healing.
Time frame: 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
Time frame: 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)
Time frame: At the end of visits 1, 2, 3 (respectively performed at screening and 7, 90, 360 days after the surgery)
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
Time frame: 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.
Time frame: About 360 days after surgical treatment of bone defect
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The First Affiliated Hospital of Xinxiang Medical College