Rebuilding long limb bones using your own bone marrow stem cells and decalcified bone scaffolds

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

This will try tissue-engineered bone made from your own bone marrow stem cells combined with a decalcified bone scaffold to repair long tubular bone defects in adults.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 55 Years
• Sex: All
• Sponsor: The First Affiliated Hospital of Xinxiang Medical College (Academic / other)
• Locations: 1 site (Xinxiang, Henan)
• Trial ID: NCT07066228 on ClinicalTrials.gov

What this trial studies

Investigators harvest a patient’s bone marrow mesenchymal stem cells (BMSCs), expand and induce them in vitro, and seed them onto a commercially available decalcified bone matrix (DBM) to create tissue-engineered bone. The engineered graft is implanted to repair long tubular limb defects such as nonunions with >30% cross-sectional bone loss or solitary bone cysts involving >50% of the cortex, generally 2–3 cm in length. The trial enrolls adults aged 18–55 and excludes patients with local infection, tumors, systemic bone disorders, severe osteoporosis, severe systemic illness, or substance abuse. The approach aims to provide abundant, patient-derived graft material with low immune risk and to avoid donor-site morbidity, though larger controlled clinical evidence is limited.

Who should consider this trial

Good fit: Adults 18–55 with long tubular limb defects 2–3 cm in length with >30% cross-sectional bone loss or solitary bone cysts affecting >50% of the bone cross-section.

Not a fit: Patients with active local infection, bone tumors or tuberculosis, systemic metabolic bone diseases, moderate-to-severe osteoporosis, severe comorbid conditions, heavy substance use, or psychiatric instability are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, this could provide a plentiful, patient-derived graft option that reduces donor-site problems and improves healing of long bone defects.

How similar studies have performed: Small clinical and preclinical reports of BMSC-seeded scaffolds and DBM show promising bone formation, but large randomized trials confirming consistent clinical benefit are lacking.

Eligibility criteria

Inclusion Criteria:

1. Age: 18-55 years old, gender unrestricted;
2. Defective nonunion with bone loss exceeding 30% of the bone cross-section and a length of 2-3 cm;
3. Solitary bone cysts involving more than 50% of the bone cross-section.

Exclusion Criteria:

1. Combined with local tumors, tuberculosis, infections or other bone-healing affecting lesions;
2. Systemic diseases affecting bone healing such as osteofibrous dysplasia, osteogenesis imperfecta, bone dystrophic diseases, and metabolic bone disorders;
3. Moderate-to-severe osteoporosis (BMD: T-score \< -2.5);
4. Severe systemic conditions including systemic malnutrition, systemic infectious diseases, severe cardiopulmonary diseases, coagulation disorders, and major organ failure;
5. Complicated with severe brain trauma;
6. Heavy smoking, drug abuse, alcoholism, or other harmful addictions;
7. Psychiatric disorders or patients with menopausal symptoms;
8. Concurrent participation in other studies or recent completion (within 4 weeks) of other clinical trials;
9. Pregnancy, lactation, or planned pregnancy within one year after initial enrollment;
10. Psychological conditions impairing treatment compliance;
11. Congenital malformations of vital organs or other systems;
12. Nonunion caused by malignant tumor resection;
13. Refusal to accept tissue-engineered bone repair protocol.

Where this trial is running

Xinxiang, Henan

• The First Affiliated Hospital of Xinxiang Medical College — Xinxiang, Henan, China (Recruiting)

Study contacts

• Principal investigator: Wenjie Ren — The First Affiliated Hospital of Xinxiang Medical College
• Study coordinator: Wenjie Ren

Conditions Defective Composite Restorations; Bone Cysts; Bone Defect; Bone Nonunion; autologous bone marrow mesenchymal stem cells; DBM; long tubular bone defects of limbs