A Phase 1/2 interventional study of CS-ACI in Osteochondritis, Osteochondritis Dissecans and Joint Diseases, sponsored by Yan Jin. Status unknown at 3 sites in China. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2012-10-01.
Sponsored by Yan Jin · Phase 1/2, Interventional, and Treatment
In this study,the Autologous chondrocyte implantation (ACI)technology and cell sheet technology are used to Cells Sheet-Autologous Chondrocyte Implantation(CS-ACI) for treating Cartilage Defects.The Safety and Efficacy Study of CS-ACI are evaluated.
All procedures are carried out after obtaining informed written consent from patients. Cartilage tissue is acquired from the Non-weight-bearing area of patients. chondrocyte are isolated and grown in culture for 6-8 weeks. After this time interval, the cells are reprocessed and the cell sheet is obtained. Implantation of the chondrocyte sheet into the Cartilage defect of the keen.The patients will be assessed clinically with scoring systems preoperatively as well as 24 months postoperatively to assess relief of symptoms and joint function. Radiological assessment (MRIs)of the affected joints will be performed at the same time points aforementioned to assess integrity of the formed cartilage. Second look arthroscopy and biopsy will also be performed to histologically assess the repair tissue and grade it via arthroscopic grading system according to the International Cartilage Repair Society guidelines.
30 studies on the registry are indexed under Osteochondritis Dissecans; 7 are open to participants now.
This study's planned enrollment of 10 is below the median of 45 across 17 interventional studies indexed under Osteochondritis Dissecans.
Browse Osteochondritis Dissecans studies →This is the only study on the registry with Yan Jin as lead sponsor.
Compared within Osteochondritis Dissecans, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Osteochondritis. The counts are of registry records indexed under each term, refreshed daily. How we classify →
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Group/Cohort Label： pretherapy post-treatment Group/Cohort Description ：The CS-ACI is used to prepare cell sheet and implant to the Cartilage defects.The arm of safety and efficacy are compared preoperative observation with postoperative observation.
Drug: CS-ACI
Procedure: Self-control. Cells Sheet-Autologous Chondrocyte Implantation(CS-ACI) includes an arthroscopy for harvesting of cartilage 6-8 weeks prior to the open cartilage surgery. Other Names: Cells Sheet-Autologous Chondrocyte Implantation （CS-ACI）
Also known as: Cells Sheet-Autologous Chondrocyte Implantation（ CS-ACI）
Mean change from baseline in the MRI
Time frame: 3month,6 month, 12 months, 24 months
Change from Baseline in the Lysholm
Time frame: 3month,6 month, 12 months, 24 months
Change from Baseline in the Knee injury and Osteoarthritis Outcome Score (KOOS)Which consists of five sub- categories = Pain, ADL, QOL, Symptoms, Sport
Time frame: 3month,6 month, 12 months, 24 months
This study is status unknown, as verified in Sep 2012. You cannot join it, but the record below documents what was studied.
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