Tissue-engineered cartilage repair for knee cartilage defects

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

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

Study contacts

• Study coordinator: Wenjie Ren
• Email: 13937354075@163.com
• Phone: 8613937354075

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.