RecruitingNot ApplicableNCT07066228

Bone Reconstruction With Autologous Bone Marrow Mesenchymal Stem Cells in Vitro to Repair Long Tubular Bone Defects

Clinical Transformation of Bone Reconstruction With Autologous Bone Marrow Mesenchymal Stem Cells in Vitro to Repair Long Tubular Bone Defects of Limbs


Sponsor

The First Affiliated Hospital of Xinxiang Medical College

Enrollment

30 participants

Start Date

Aug 7, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 55 Years

Inclusion Criteria3

  • 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.

Exclusion Criteria13

  • 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;
  • 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.

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Interventions

DEVICEtissue-engineered bone

Commercial decalcified bone scaffolds were combined with autologous bone marrow mesenchymal stem cells to form tissue engineered bone in vitro


Locations(1)

The First Affiliated Hospital of Xinxiang Medical College

Xinxiang, Henan, China

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NCT07066228


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