Tissue Engineered Cartilage to Repairing Articular Cartilage Defects

NCT07094100 | Recruiting DMC

• 1 other identifier: TECOA-2021
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The joint cartilage constructed by combining bone marrow mesenchymal stem cells with three-dimensional materials has achieved the goal of repairing joint cartilage.

Conditions

Cartilage Injury; OA Knee

Outcome Measures

Primary Outcomes (1)

• KSS score

  subjective knee clinical and functional score (0-100)score.100 is better in function

  before the operation, at 3, 6, 12 and 24 months after the operation.

Secondary Outcomes (3)

• Koos scores

  before the operation, at 3, 6, 12 and 24 months after the operation.

• Lysholm score

  before the operation, at 3, 6, 12 and 24 months after the operation.

• WOMAC score

  before the operation, at 3, 6, 12 and 24 months after the operation.

Study Arms (1)

Tissue-engineered cartilage to repair articular cartilage defects

EXPERIMENTAL

Device: Tissue engineered cartilage

Interventions

Tissue engineered cartilage DEVICE

Cartilage constructed by autologous bone marrow mesenchymal stem cells

Tissue-engineered cartilage to repair articular cartilage defects

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patients' age ranges from 18 to 65 years old, and gender is not restricted;
• The imaging results show that the epiphyseal growth is mature;
• The defects or localized injuries of joint cartilage caused by trauma or other reasons;
• The injured area is the distal weight-bearing surface of the femoral condyle of the knee joint, with no more than 4 lesions, and there is no injury to the cruciate ligaments;
• The patients voluntarily sign and provide a written informed consent form and are willing to closely cooperate with the doctor's strict postoperative rehabilitation program.

You may not qualify if:

• The patient is extremely overweight, with a body mass index greater than 35;
• The lower limb alignment is valgus by more than 10° and varus by more than 5°;
• Multiple ligament injuries;
• There are numerous bad habits such as heavy smoking, drug abuse, and excessive alcohol consumption;
• Has undergone open knee joint surgery within the past six months;
• Has severe joint stiffness or fibrosis;
• Has an allergic constitution or a history of allergic reactions to collagen;
• Has mental abnormalities;
• Cannot or is unwilling to undergo rehabilitation training;
• Has primary cardiovascular diseases, lung diseases, endocrine and metabolic disorders, or other serious diseases that affect their daily life, such as tumors or AIDS;
• Pregnant or lactating women, or those planning to conceive during the trial period;
• Other acute or chronic diseases, for which the researchers consider surgery to be inappropriate.

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

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

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: June 25, 2025
• First Posted: July 30, 2025
• Study Start: April 20, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: May 4, 2026

Record last verified: 2025-07

Locations

CN (1)