Tissue-engineered cartilage repair for knee cartilage defects

Clinical Study of Cartilage Constructed by Autologous Bone Marrow Mesenchymal Stem Cells in Repairing Articular Cartilage Defects

This trial will try tissue-engineered cartilage made from a patient's own bone marrow stem cells to repair cartilage defects in adults with knee injuries or osteoarthritis.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: The First Affiliated Hospital of Xinxiang Medical College (Academic / other)
• Locations: 1 site (Xinxiang, Henan)
• Trial ID: NCT07094100 on ClinicalTrials.gov

What this trial studies

The intervention uses autologous bone marrow mesenchymal stem cells expanded in vitro and combined with a three-dimensional scaffold to create living cartilage for implantation. The engineered tissue is implanted into focal defects on the distal weight-bearing surface of the femoral condyle of the knee. Eligible adults (18–65) with up to four localized lesions and intact cruciate ligaments undergo surgery and a strict postoperative rehabilitation program with planned clinical follow-up. Outcomes will include measures of cartilage repair, joint function, and safety over the follow-up period.

Who should consider this trial

Good fit: Adults aged 18–65 with mature growth plates who have up to four focal cartilage defects on the distal weight-bearing femoral condyle, intact cruciate ligaments, and willingness to follow the postoperative rehabilitation program are ideal candidates.

Not a fit: Patients with BMI over 35, significant lower-limb malalignment (valgus >10° or varus >5°), multiple ligament injuries, heavy smoking/drug/alcohol use, or recent open knee surgery are unlikely to receive benefit from this approach.

Why it matters

Potential benefit: If successful, this approach could restore damaged cartilage, improve knee function, and slow progression to osteoarthritis, potentially reducing the need for more invasive surgeries.

How similar studies have performed: Laboratory and early clinical work indicates BMSC-based tissue-engineered cartilage can form cartilage-like tissue, but large-scale clinical success and long-term superiority over standard treatments remain limited.

Eligibility criteria

Inclusion Criteria:

1. The patients' age ranges from 18 to 65 years old, and gender is not restricted;
2. The imaging results show that the epiphyseal growth is mature;
3. The defects or localized injuries of joint cartilage caused by trauma or other reasons;
4. 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;
5. 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.

Exclusion Criteria:

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

Where this trial is running

Xinxiang, Henan

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

Study contacts

• Study coordinator: Wenjie Ren

Conditions Cartilage Injury; OA Knee