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

NCT07066228 | Recruiting DMC

• 1 other identifier: TEBLTBD-2022-02
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Defective Composite Restorations; Bone Cysts; Bone Defect; Bone Nonunion

Keywords

autologous bone marrow mesenchymal stem cells; DBM; long tubular bone defects of limbs

Outcome Measures

Primary Outcomes (3)

• The scores of bone healing

  The scores of bone healing are divided into three kinds: nonhealing: 0；delayed healing: 1; normal healing.

  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

  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)

  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

  About 360 days after surgical treatment of bone defect

• The scores of pain

  About 360 days after surgical treatment of bone defect

Study Arms (1)

Tissue engineered bone on bone defect

OTHER

Device: tissue-engineered bone

Interventions

tissue-engineered bone DEVICE

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

Tissue engineered bone on bone defect

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The First Affiliated Hospital of Xinxiang Medical College: lead

Study Sites (1)

The First Affiliated Hospital of Xinxiang Medical College

Xinxiang, Henan, 453000, China

RECRUITING

MeSH Terms

Conditions

Bone Cysts

Condition Hierarchy (Ancestors)

Cysts; Neoplasms; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Wenjie Ren

  The First Affiliated Hospital of Xinxiang Medical College

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wenjie Ren

CONTACT

8613937354075; 13937354075@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 11, 2025
• First Posted: July 15, 2025
• Study Start: August 7, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: January 2, 2026

Record last verified: 2025-12

Locations

CN (1)