1. Home
  2. Approved trials
  3. » فارسی

Comparison of Transplantation of Mesenchymal Stem Cells and Autologous Chondrogenic Pre-Differentiated Mesenchymal Stem Cells for the Treatment of Cartilage Lesions of knee joint

Protocol summary

Summary
The aim of the present study was to transplant autologous chondrogenic pre-differentiated mesenchymal stem cells to treat patients with knee cartilage lesions. For this purpose, 16 patients aged between 15 and 40 with joint cartilage injuries (lesion size between 2.5 and 6 cm in internal or external femoral condylar) are included in this study. The selected individuals should not have any metabolic, infectious, and malnutrition or have not used any special medication. Sixteen patients are selected, which then devided into two groups; a control group that receives only synovial mesenchymal stem cells and a treatment group that receives chondrogenic pre-differentiated mesenchymal stem cells. After transplantation, patients were evaluated for improvement at 3, 6, 12, and 18 weeks after treatment by arthroscopy and MRI. At the end of the course, a synovial fluid was sampled and joint biopsy was performed to determine the biochemical factors such as glycosamineglycans, hydroxyproline. Gene and protein expression, like aggrecan, collagen type 2 and sox9 are also investigated using Real-time PCR and immunocytochemistry.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017052634053N2
Registration date: 2017-07-13, 1396/04/22
Registration timing: prospective

Last update:
Update count: 0
Registration date
2017-07-13, 1396/04/22
Registrant information
Name
Gholamreza Ghorbani Amjad
Name of organization / entity
Hamadan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 919 521 6837
Email address
ghorbaniamjad@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Hamedan University of Medical Sciences
Expected recruitment start date
2017-08-23, 1396/06/01
Expected recruitment end date
2019-08-23, 1398/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Transplantation of Mesenchymal Stem Cells and Autologous Chondrogenic Pre-Differentiated Mesenchymal Stem Cells for the Treatment of Cartilage Lesions of knee joint
Public title
The use of stem cells for the treatment of the cartilage lesions
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: aged between 15 years to 40 years; the lesion between 2.5 and 6 square centimeters; the lesions of trauma sports and non-sports injury; femoral condyle internal or external lesions Exclusion criteria: Obesity; corticosteroid injection less than 3 months ago; hyaluronic acid injection less than 6 months ago; varus and valgus more than 5 degree; diabetes type one and two; autoimmune disease; malnutrition; certain neurological diseases; history of allergy; infectious diseases
Age
From 15 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 16
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Hamadan University of Medical Sciences
Street address
Hamadan University of Medical Sciences, Shahid Fahmideh Blvd, Hamadan, Iran
City
Hamadan
Postal code
Approval date
2017-04-22, 1396/02/02
Ethics committee reference number
IR.UMSHA.REC.1396.81

Health conditions studied

1

Description of health condition studied
Destructive lesions of the knee joint cartilage
ICD-10 code
M94.9
ICD-10 code description
Disorder of cartilage, unspecified

Primary outcomes

1

Description
Articular cartilage lesions of the knee
Timepoint
3.6.12,18 weeks
Method of measurement
MRI and diagnostic arthroscopy

Secondary outcomes

1

Description
glycosaminoglycans, collagen, gene and protein expression of, agercan, collagen type II and sox9
Timepoint
Eighteenth week
Method of measurement
biochemical, molecular and immunocytochemistry analysis

Intervention groups

1

Description
Control group: This group will receive only autologous mesenchymal stem cells. One to two million cells are spilled in the alginate bed and the medium is changed every three days until the alginate is saturated with the MSCs. Alginate will then be transplanted into the affected area. Alginate volume is determined based on the amount of damage space.
Category
Treatment - Other

2

Description
Intervention group: This group receives autologous chondrogenic pre-differentiated mesenchymal stem cells (MSCs). One to two million cells are spilled in the alginate bed and the medium is changed every three days until the alginate is saturated with the MSCs. Then we use induced media to differentiate the cells. When they induced to autologous chondrogenic pre-differentiated, the alginate containing these cells will be transplanted into the affected area. Alginate volume is determined based on the amount of damage space.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Hamadan Besat Hospital
Full name of responsible person
Dr Gholamreza Ghorbani Amjad
Street address
Department of Orthopedics, School of Medicine, Hamadan University of Medical Sciences, Hamdan, Iran
City
Hamadan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Dr Saeid Bashirian
Street address
Vice Chancellor For Research And Technology, Hamadan University of Medical Sciences, Shahid Fahmideh Blvd, Hamadan, Iran
City
Hamadan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Hamadan University of Medical Sciences
Proportion provided by this source
100
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

Person responsible for general inquiries

Contact
Name of organization / entity
Hamadan university of medical sciences
Full name of responsible person
Farjam Goudarzi
Position
Ph.D of Clinical Biochemistery
Other areas of specialty/work
Street address
Department of Biochemistry, School of Medicine, Hamadan University of Medical Sciences, Hamadan, Iran
City
Hamadan
Postal code
Phone
+98 81 3821 4454
Fax
Email
farjam.goudarzi@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Gholamreza Ghorbani Amjad
Position
Knee Surgery Fellowship
Other areas of specialty/work
Street address
Department of Orthopedics, School of Medicine, Hamadan University of Medical Sciences, Hamdan, Iran
City
Hamadan
Postal code
Phone
+98 81 3821 4454
Fax
Email
amjad52m@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Hamadan University of Medical Sciences
Full name of responsible person
Ali Rafat
Position
Master of Anatomical Sciences
Other areas of specialty/work
Street address
Department of Anatomical Sciences, School of Medicine, Hamadan University of Medical Sciences, Hamadan, Iran
City
Hamadan
Postal code
Phone
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
Loading...