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IRCT2017062434731N1 IRCT 2017-07-27 Avicenna Research Institute Clinical evaluation of of osteochondral regeneration using silk fibroin and collagen scaffolds Clinical evaluation of osteochondral regeneration using autologous chondrocytes seeded in bilayered 2017-07-23 anticipated 15 Complete https://irct.ir/trial/26467 interventional Randomization: N/A, Blinding: Single blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. 1-2 Osteochondral defects. Evaluation of the safety and effectiveness of the autologous chondrocytes seeded in bilayered scaffolds based on silk fibroin and collagen in presence of growth factors in the treatment of osteochondral lesions located on the femoral condyle of the patients in phase 1 and 2 clinical trial during 24 months..
public Dr Somaieh Kazemnejadi
Shahid Beheshti University, Evin
Tehran Iran (Islamic Republic of) +98 21 2243 2020 kazemnejad_s@yahoo.com Avicenna Research Institute scientific Dr Somaieh Kazemnejad
Avicenna Research Institute, Shahid Beheshti University, Evin, PO Box 19615-1177
Tehran Iran (Islamic Republic of) 00219822432020 kazemnejad_s@yahoo.com Avicenna Research Institute Iran (Islamic Republic of) Inclusion criteria: female or male; within the age range of 18 to 65 years; symptomatic osteochondral lesion of the medial or lateral femoral condyles with ICRS grade 3-4 lesion. Exclusion Criteria: meniscus removal with surgical treatment; knee non corrected instability; diagnosis with metastatic diseases or malignant diseases; pregnancy or breast feeding, history of neurological disease; history of endocrinological disorders such as diabetes; history of pulmonary heart diseases; infectious diseases such as hepatitis B and C, HIV and history of allergic diseases. 18 years 65 years Both Treatment - Surgery Evaluation of the safety and effectiveness of the autologous chondrocytes seeded in bilayered scaffolds based on silk fibroin and collagen in presence of growth factors in the treatment of osteochondral lesions located on the femoral condyle of the patients in phase 1 and 2 clinical trial during 24 months. Radiological and Clinical Studies. Timepoint: Before intervention and 6 months and 1 year after intervention. Method of measurement: Radiographic images. MRI studies. Timepoint: Before intervention and 6 months and 1 year after intervention. Method of measurement: MRI results. Pain in the surgical area. Timepoint: after intervention. Method of measurement: Based on available evidence. scientific and technological department of presidential office Avicenna Research Institute scientific and technological department of presidential office Approved 2017-05-23 Avicenna Research Institute Avicenna Research Institute, Shahid Beheshti University, Evin, PO Box 19615-1177 Tehran Iran (Islamic Republic of)