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Effect of Cell Therapy on the Clinical Signs and symptoms of Patients with Severe knee Osteoarthritis: Pilot study

Protocol summary

Study aim
Effect of Cell Therapy on the Clinical Signs and symptoms of Patients with Severe knee Osteoarthritis
Design
By random sampling method, based on a random number table Among Patients Referred to the orthopedic clinic, since the start of the project, 5 patients selected on the basis of clinical, para-clinical findings and Kellgren-Lawrence grades 2- 4 osteoarthritis that they will be selected by the physician's decision.
Settings and conduct
Patients with knee osteoarthritis referring to Orthopedic Clinic of Urmia Imam Khomeini Hospital.
Participants/Inclusion and exclusion criteria
Patients with grade 2 to 4 osteoarthritis who do not have other underlying conditions and do not consume tobacco.
Intervention groups
Stem cells extracted from each patient inject himself.
Main outcome variables
Signs and symptoms of Osteoarthritis are including morning pain and stiffness, decrease joint flexion, joint swelling and Arthritis and joint deformities.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180102038184N1
Registration date: 2018-12-29, 1397/10/08
Registration timing: registered_while_recruiting

Last update: 2018-12-29, 1397/10/08
Update count: 0
Registration date
2018-12-29, 1397/10/08
Registrant information
Name
sahar mehranfar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3235 9094
Email address
mehranfar.s@umsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-23, 1397/08/01
Expected recruitment end date
2021-04-30, 1400/02/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Cell Therapy on the Clinical Signs and symptoms of Patients with Severe knee Osteoarthritis: Pilot study
Public title
Effect of Cell Therapy on knee Osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1. Have grade 2-4 knee osteoarthritis 2. They have been taken Corticosteroids and NSAIDs for a long time, but due to its side effects , they are not able to take these group of pills. 3. Although Corticosteroids and NSAIDs have been taken for 3 months, significant improvement has not been observed in sense of pain. 4. Being in the range of 18- 85- year-old
Exclusion criteria:
1. There are have blood diseases, cancers, AIDS, and hepatitis. 2- Taking Immunosuppressive drugs for the last 6 months; NSAIDs, ASA within 7 days ago; Plavix, Warfarin within 3 days ago. 3- Tobacco users. 4- Being pregnant or breastfeeding mothers 5 - Have immune system disease 6 - BMI less than 30 7 - Susceptible to lidocaine and epinephrine 8 - Have other joint disease, such as chondrocalcinosis, rheumatoid arthritis, gout, fibromyalgia, lupus,… 9- Have a knee joint surgery up to a year ago 10 - Have arthritis in the pelvis, shoulder... 11 - Unable to tolerate the pain without taking pain killer pills for 5-7 days before each medical visit.
Age
From 18 years old to 85 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 5
More than 1 sample in each individual
Number of samples in each individual: 5
ten
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
Ethics committee of Urmia University of Medical Sciences
Street address
Orjhans Street., Resalat Blvd., Urmia University of Medical Science, Urmia., Iran
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Approval date
2018-08-16, 1397/05/25
Ethics committee reference number
IR.UMSU.REC.1397.164

Health conditions studied

1

Description of health condition studied
ostheoarthritis
ICD-10 code
M17
ICD-10 code description
Osteoarthritis of knee

Primary outcomes

1

Description
Score of signs and sypmtomes of knee osteoarthritis according to koos (Knee injury and Osteoarthritis Outcome Score) questionnaire
Timepoint
1,3,6 months after and 1 year after
Method of measurement
Magnetic Resonance Imaging (MRI) , Knee injury and Osteoarthritis Outcome Score (KOOS)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Isolated Mesenchymal stem cells that extracted form Patient's adipose tissue injected only once with 1,000,000 cells into intra-articular knee joint by an Orthopedic surgeon.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Urmia Emam khomeini Hospital
Full name of responsible person
Sahar Mehranfar
Street address
Orjhans Street., Resalat Blvd., Urmia University of Medical Science
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3223 4897
Email
mehranfar.s@umsu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Sahar Mehranfar
Street address
Orjhans Street., Resalat Blvd., Urmia University of Medical Science
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3223 4897
Email
mehranfar.s@msum.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Oroumia University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Sahar Mehranfar
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
cell therapy, cancer diagnosis in early stage
Street address
Orjhans Street., Resalat Blvd., Urmia University of Medical Science
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3223 4897
Email
mehranfar.s@msum.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Sahar Mehranfar
Position
Assist. Prof
Latest degree
Ph.D.
Other areas of specialty/work
cell therapy
Street address
Orjhans Street., Resalat Blvd., Urmia University of Medical Science
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3223 4897
Email
mehranfar.s@umsu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Oroumia University of Medical Sciences
Full name of responsible person
Sahar Mehranfar
Position
Academic staff
Latest degree
Ph.D.
Other areas of specialty/work
cell therapy
Street address
Resalat blv, orzhnas alley
City
Urmia
Province
West Azarbaijan
Postal code
5714783734
Phone
+98 44 3223 4897
Email
mehranfar.s@umsu.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
The whole data can be shared after being unidentified and after the end of the study
When the data will become available and for how long
After the article is published
To whom data/document is available
All academic researchers
Under which criteria data/document could be used
Future studies
From where data/document is obtainable
The executor of the plan
What processes are involved for a request to access data/document
Formal email from academic email
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