Cartilage tissue engineering applications commonly encompass the use of three-dimensional scaffolds to provide a suitable microenvironment for the incorporation of cells or growth factors to regenerate damaged tissues. Silk fibroin scaffolds are typically porous, biocompatible and biodegradable materials that support physical and biochemical stimuli for optimal cell growth and function. In addition, over the last years autologous chondrocyte transplantation (ACT) as an advanced, cell-based technology, use for the treatment of chondral defects of the knee. The purpose of this trial is to evaluate 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.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017062434731N1
Registration date:2017-07-27, 1396/05/05
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-07-27, 1396/05/05
Registrant information
Name
Manijeh Khanmohammadi
Name of organization / entity
Avicenna Research Institute
Country
Iran (Islamic Republic of)
Phone
+98 21 2243 2020
Email address
m.khanmohammadi@ari.ir
Recruitment status
Recruitment complete
Funding source
Avicenna Research Institutescientific and technological department of presidential office
Expected recruitment start date
2017-07-23, 1396/05/01
Expected recruitment end date
2019-07-23, 1398/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical evaluation of osteochondral regeneration using autologous chondrocytes seeded in bilayered
Public title
Clinical evaluation of of osteochondral regeneration using silk fibroin and collagen scaffolds
Purpose
Treatment
Inclusion/Exclusion criteria
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.
Age
From 18 years old to 65 years old
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
15
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Avicenna Research Institute
Street address
Avicenna Research Institute, Shahid Beheshti University, Evin, PO Box 19615-1177
City
Tehran
Postal code
1936773493
Approval date
2017-05-23, 1396/03/02
Ethics committee reference number
IR.ACECR.Avicenna.REC.1396.4
Health conditions studied
1
Description of health condition studied
Osteochondral defects
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Radiological and Clinical Studies
Timepoint
Before intervention and 6 months and 1 year after intervention
Method of measurement
Radiographic images
2
Description
MRI studies
Timepoint
Before intervention and 6 months and 1 year after intervention
Method of measurement
MRI results
Secondary outcomes
1
Description
Pain in the surgical area
Timepoint
after intervention
Method of measurement
Based on available evidence
Intervention groups
1
Description
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.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Shariati Hospital
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Avicenna Research Institute
Full name of responsible person
Dr Somaieh Kazemnejad
Street address
Avicenna Research Institute, Shahid Beheshti University, Evin, PO Box 19615-1177
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Avicenna Research Institute
Proportion provided by this source
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
2
Sponsor
Name of organization / entity
scientific and technological department of presidential office