RecruitingNot Applicable

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

China30 participantsStarted 2025-08-07

Plain-language 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.

Who can participate

Age range18 Years – 55 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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 criteria

✕. 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;

What they're measuring

The scores of bone healing

Timeframe: About 360 days after surgical treatment of bone defect

The adverse event incidence using tissue-engineered bone

Timeframe: About 360 days after surgical treatment of bone defect

Bone union (bone healing) evaluation through modified lane and sandhu radiological scoring system

Timeframe: At the end of visits 1, 2, 3 (respectively performed at screening and 7, 90, 360 days after the surgery)

Trial details

NCT IDNCT07066228

SponsorThe First Affiliated Hospital of Xinxiang Medical College

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-01

Contact for this trial

Wenjie Ren

8613937354075 13937354075@163.com

View on ClinicalTrials.gov More Defective Composite Restorations trials

Who can participate

Age range18 Years – 55 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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 criteria

✕. 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;

What they're measuring

The scores of bone healing

Timeframe: About 360 days after surgical treatment of bone defect

The adverse event incidence using tissue-engineered bone

Timeframe: About 360 days after surgical treatment of bone defect

Bone union (bone healing) evaluation through modified lane and sandhu radiological scoring system

Timeframe: At the end of visits 1, 2, 3 (respectively performed at screening and 7, 90, 360 days after the surgery)