Traumatic osteoarthritis, degenerative diseases or age-related diseases, have been controversial in terms of treatment. New methods of treatment, including stem cell transplantation in articular cartilage defects, are studied. Stem cells of the bone marrow include hematopoietic, mesenchymal and stromal stem cells. Several studies have been conducted on the use of bone marrow mononuclear cells in treatment of articular cartilage disorders. The costs of this style are less than autologous chondrocyte transplantation; that is why it is named easy one-stage style. In this study, the effect of transplantation of autologous bone marrow stem cells on pain relief and improvement of joint function was evaluated in at least 10 patients with knee osteoarthritis who had the inclusion criteria and volunteers participating in the study. IKDC evaluation form and a physical exam were done by an orthopedic collaborator. A hematology-oncology specialist obtained 30-70 ml heparinized bone marrow sample from the iliac crest. Bone marrow mononuclear cells were isolated under GMP in the clean room. After direct injection of the cells into the joint, the patients were followed by clinical examination and other evaluations including conventional radiography of the knee and knee MRI in several stages.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015050922174N1
Registration date:2015-08-11, 1394/05/20
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-08-11, 1394/05/20
Registrant information
Name
Maryam Ayatollahi
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3628 1529
Email address
ssci@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2014-05-05, 1393/02/15
Expected recruitment end date
2016-05-04, 1395/02/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of autologous bone marrow stem cells in treatment of knee osteoarthritis
Public title
The effect of autologous bone marrow stem cells on knee osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients with knee joint osteoarthritis referring to orthopedic and rehabilitation clinics, cell therapy center of Ghadir Mother and Child hospital, and hospitals affiliated to Shiraz University of Medical Sciences.
Exclusion criteria: very advanced or severe osteoarthritis; age over 65 years old; BMI greater than 25; inflammatory joint and rheumatic disease; history of cancer; chemotherapy or use of immunosuppressive drugs; diabetes; history of smoking; Knee joint laxity; varus and valgus deformity of the knee.
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
10
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shiraz University of Medical Sciences
Street address
Zand Street
City
Shiraz
Postal code
Approval date
2014-02-24, 1392/12/05
Ethics committee reference number
92/429770
Health conditions studied
1
Description of health condition studied
knee osteoarthritis
ICD-10 code
m19.0
ICD-10 code description
Primary arthrosis of other joints
Primary outcomes
1
Description
Activity level function
Timepoint
3, 6, 12 month
Method of measurement
History
Secondary outcomes
1
Description
Swelling and morning stiffness
Timepoint
3, 6, 12 month
Method of measurement
History and physical exam
2
Description
Severity and frequency of pain
Timepoint
3, 6, 12 month
Method of measurement
History
3
Description
Knee locking and giving way
Timepoint
3, 6, 12 month
Method of measurement
History
4
Description
Activity level before and after injection
Timepoint
3, 6, 12 month
Method of measurement
History
Intervention groups
1
Description
Treatment by injection of stem cells
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Orthopedic Clinics Affiliated to Shiraz University of Medical Sciences, and Ghadir Mother and Child
Full name of responsible person
Street address
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
DR.Seyyed Basir Hashemi
Street address
Zand Street
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Dr.Maryam Ayatollahi
Position
Associate Professor
Other areas of specialty/work
Street address
Zand Street
City
Shiraz
Postal code
Phone
+98 71 3227 9711
Fax
Email
ayatollmb@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr.Maryam Ayatollahi
Position
Associate Professor, PHD in Genetics
Other areas of specialty/work
Street address
Zand Street
City
Shiraz
Postal code
Phone
+98 71 3227 9711
Fax
Email
ayatollmb@yahoo.com
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)