Autologous Cell-derived Tissue Engineered Cartilage for Repairing Articular Cartilage Lesions
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|ClinicalTrials.gov Identifier: NCT02770209|
Recruitment Status : Unknown
Verified May 2016 by Quanyi Guo, Chinese PLA General Hospital.
Recruitment status was: Active, not recruiting
First Posted : May 12, 2016
Last Update Posted : May 12, 2016
|Condition or disease||Intervention/treatment||Phase|
|Cartilage Diseases||Biological: biomimetic cartilage matrix + autologous chondrocytes Procedure: arthroscopic debridement Procedure: microfracture surgery||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Autologous Cell-derived Tissue Engineered Cartilage for Repairing Articular Cartilage Lesions: a Protocol for a Prospective, Randomized, Controlled Clinical Trial|
|Study Start Date :||February 2012|
|Actual Primary Completion Date :||August 2013|
|Estimated Study Completion Date :||June 2016|
Experimental: the experimental group
Patients in the experimental group will be treated with the biomimetic cartilage matrix combined with autologous chondrocytes. The entire course of treatment includes two surgeries. The first surgery will be performed to observe articular cartilage damage by arthroscopy and assess treatment potential. If the patient's condition meets the surgical requirement, we will extract cartilage from the fossa intercondylar non-weight-bearing area during the first surgery. Chondrocytes will be in vitro-amplified and inoculated into the cartilage scaffold. The fully prepared seeded scaffold will be implanted into the site of injury during the second surgery.
Biological: biomimetic cartilage matrix + autologous chondrocytes
Experimental: the control group
Patients in the control group will be subjected to arthroscopic debridement and microfracture surgery.
Procedure: arthroscopic debridement
Procedure: microfracture surgery
- Change of Magnetic resonance imaging(MRI) [ Time Frame: Before treatment and month 3, month 6, month 12, month 18 after surgery ]using joint MRI, cartilage thickness and fusion with surrounding normal cartilage and subchondral bone, as well as the presence or absence of articular effusion and subchondral bone edema will be assessed.
- Change of Lysholm score [ Time Frame: Before treatment and month 3, month 6, month 12, month 18 after surgery ]The Lysholm score is out of a possible 100 points.
- Change of 2000 IKDC subjective knee evaluation score [ Time Frame: Before treatment and month 3, month 6, month 12,month 18 after surgery ]A higher score indicates better knee function. IKDC score is used to evaluate knee function and symptoms. 100 points represents no restrictions of daily life and sports.
- Change of KOOS survey [ Time Frame: Before treatment and month 3, month 6, month 12,month 18 after surgery ]
- Change of the VAS pain scale [ Time Frame: Before treatment and month 3, month 6, month 12,month 18 after surgery ]Joint pain will be evaluated with the VAS pain scale; 0 = painless, 10 = severe pain.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02770209
|Principal Investigator:||Quanyi Guo, Ph.D||Institute of Orthopedics, Chinese PLA Hospital, Beijing, China|