Evaluation of safety and efficacy of intra-articular transplantation of allogeneic adipose derived mesenchymal stromal cells in patients with knee joint osteoarthritis An interventional randomized triple-blind placebo controlled clinical trial phase I/II
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Protocol summary
First we will recruit 10 patients with osteoarthritis admitted in orthopedic clinic of shafa yahyaiean hospital evaluating safety of allogeneic adipose derived mesenchymal stem cells, and if there were no serious side effects after 3 months, another 90 patients in two groups: case group (allogeneic adipose derived MSCs) and control group (normal saline) will be studied in terms of their positive effects in pain reduction and improvement in physical function.
First we will recruit 3 patients with osteoarthritis admitted in orthopedic clinic of shafa yahyaiean hospital evaluating safety of allogeneic adipose derived mesenchymal stem cells, and if there were no serious side effects after 3 months, another 90 patients in two groups: case group (allogeneic adipose derived MSCs) and control group (normal saline) will be studied in terms of their positive effects in pain reduction and improvement in physical function.
First we will recruit 103 patients with osteoarthritis admitted in orthopedic clinic of shafa yahyaiean hospital evaluating safety of allogeneic adipose derived mesenchymal stem cells, and if there were no serious side effects after 3 months, another 90 patients in two groups: case group (allogeneic adipose derived MSCs) and control group (normal saline) will be studied in terms of their positive effects in pain reduction and improvement in physical function.
ابتدا 10 بیمار مبتلا به استئو آرتريت مراجعه کننده به کلینیک ارتوپدی بیمارستان شفا یحیائیان، از لحاظ ایمنی سلولهای مزانشیمی مشتق از بافت چربی غیر خودی بررسی شده و در صورت عدم بروز عوارض جانبی جدی پس از سه ماه، 90 بیمار دیگر وارد مطالعه گشته و در دو گروه مورد (سلولهای مزانشیمی مشتق از بافت چربی غیر خودی داخل مفصل) و شاهد (نرمال سالین) از لحاظ اثرات مثبت این سلولها در کاهش درد و بهبود فعالیت فیزیکی، مورد مطالعه قرار می گیرند.
ابتدا 3 بیمار مبتلا به استئو آرتريت مراجعه کننده به کلینیک ارتوپدی بیمارستان شفا یحیائیان، از لحاظ ایمنی سلولهای مزانشیمی مشتق از بافت چربی غیر خودی بررسی شده و در صورت عدم بروز عوارض جانبی جدی پس از سه ماه، 90 بیمار دیگر وارد مطالعه گشته و در دو گروه مورد (سلولهای مزانشیمی مشتق از بافت چربی غیر خودی داخل مفصل) و شاهد (نرمال سالین) از لحاظ اثرات مثبت این سلولها در کاهش درد و بهبود فعالیت فیزیکی، مورد مطالعه قرار می گیرند.
ابتدا 103 بیمار مبتلا به استئو آرتريت مراجعه کننده به کلینیک ارتوپدی بیمارستان شفا یحیائیان، از لحاظ ایمنی سلولهای مزانشیمی مشتق از بافت چربی غیر خودی بررسی شده و در صورت عدم بروز عوارض جانبی جدی پس از سه ماه، 90 بیمار دیگر وارد مطالعه گشته و در دو گروه مورد (سلولهای مزانشیمی مشتق از بافت چربی غیر خودی داخل مفصل) و شاهد (نرمال سالین) از لحاظ اثرات مثبت این سلولها در کاهش درد و بهبود فعالیت فیزیکی، مورد مطالعه قرار می گیرند.
General information
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empty
Recruitment centers
#1
Name of recruitment center - English: Orthopedic clinic of Shafa yahyaeian hospital
Name of recruitment center - Persian: کلینیک ارتوپدی بیمارستان شفا یحیائیان
Full name of responsible person - English: Dr. Abolfazl Bagheri fard
Full name of responsible person - Persian: دکتر ابوالفضل باقری فرد
Street address - English: Mojahedin e eslam street, Baharestan Square
Street address - Persian: میدان بهارستان، خیابان مجاهدین اسلام
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: ۱۴۴۹۶۱۴۵۳۵
Phone: +98 21 3354 2006
Fax:
Email: bagherifard@gmail.com
Web page address:
Name of recruitment center - English: Orthopedic Clinic of Shafa Yahyaeian hospital
Name of recruitment center - Persian: کلینیک ارتوپدی بیمارستان شفا یحیائیان
Full name of responsible person - English: Dr. Abolfazl Bagheri fard
Full name of responsible person - Persian: دکتر ابوالفضل باقری فرد
Street address - English: Mojahedin e eslam street, Baharestan Square
Street address - Persian: میدان بهارستان، خیابان مجاهدین اسلام
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: ۱۴۴۹۶۱۴۵۳۵
Phone: +98 21 3354 2006
Fax:
Email: bagherifard@gmail.com
Web page address:
Name of recruitment center - English: Orthopedic clinicClinic of Shafa yahyaeianYahyaeian hospital Name of recruitment center - Persian: کلینیک ارتوپدی بیمارستان شفا یحیائیان Full name of responsible person - English: Dr. Abolfazl Bagheri fard Full name of responsible person - Persian: دکتر ابوالفضل باقری فرد Street address - English: Mojahedin e eslam street, Baharestan Square Street address - Persian: میدان بهارستان، خیابان مجاهدین اسلام City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: ۱۴۴۹۶۱۴۵۳۵ Phone: +98 21 3354 2006 Fax: Email: bagherifard@gmail.com Web page address:
Sponsors / Funding sources
#1
contact.organization_id:
Name of organization / entity - English: Shafa yahyaeian hospital
Name of organization / entity - Persian: بیمارستان شفا یحیائیان
Full name of responsible person - English: Abolfazl Bagheri fard
Full name of responsible person - Persian: ابوالفضل باقری فرد
Street address - English: Mojahedin e eslam street, Baharestan Sq
Street address - Persian: میدان بهارستان،خیابان مجاهدین اسلام
City - English: tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: ۱۴۴۹۶۱۴۵۳۵
Phone: +98 21 3354 2001
Fax:
Email: bagherifard@gmail.com
Web page address:
contact.organization_id:
Name of organization / entity - English: Shafa Yahyaeian Hospital
Name of organization / entity - Persian: بیمارستان شفا یحیائیان
Full name of responsible person - English: Abolfazl Bagheri fard
Full name of responsible person - Persian: ابوالفضل باقری فرد
Street address - English: Mojahedin e eslam street, Baharestan Sq
Street address - Persian: میدان بهارستان،خیابان مجاهدین اسلام
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: ۱۴۴۹۶۱۴۵۳۵
Phone: +98 21 3354 2001
Fax:
Email: bagherifard@gmail.com
Web page address:
contact.organization_id: Name of organization / entity - English: Shafa yahyaeian hospitalYahyaeian Hospital Name of organization / entity - Persian: بیمارستان شفا یحیائیان Full name of responsible person - English: Abolfazl Bagheri fard Full name of responsible person - Persian: ابوالفضل باقری فرد Street address - English: Mojahedin e eslam street, Baharestan Sq Street address - Persian: میدان بهارستان،خیابان مجاهدین اسلام City - English: tehranTehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: ۱۴۴۹۶۱۴۵۳۵ Phone: +98 21 3354 2001 Fax: Email: bagherifard@gmail.com Web page address:
Protocol summary
Study aim
Evaluation of safety and efficacy of intra-articular transplantation of allogeneic adipose-derived mesenchymal stem cells on pain relieving and physical activity improvement, in patients with knee joint osteoarthritis.
Design
A triple-blind randomized controlled clinical trial phase I/II
Settings and conduct
First we will recruit 3 patients with osteoarthritis admitted in orthopedic clinic of shafa yahyaiean hospital evaluating safety of allogeneic adipose derived mesenchymal stem cells, and if there were no serious side effects after 3 months, another 90 patients in two groups: case group (allogeneic adipose derived MSCs) and control group (normal saline) will be studied in terms of their positive effects in pain reduction and improvement in physical function.
Participants/Inclusion and exclusion criteria
Patients with 18 to 65 years old Whose arthritis is detected with MRI and are not affected with chronic diseases or cancer, are recruited.
Intervention groups
Intra-articular transplantation of 100 millions of allogeneic adipose-derived mesenchymal stromal cells in case group and injection of 3-5 ml NL/S in control group
Main outcome variables
evaluation of allogeneic adipose derived MSCs transplantation on pain and patient’ physical activity and the thickness of affected cartilage
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20080728001031N23
Registration date:2018-04-24, 1397/02/04
Registration timing:registered_while_recruiting
Last update:2021-08-26, 1400/06/04
Update count:1
Registration date
2018-04-24, 1397/02/04
Registrant information
Name
Nasser Aghdami
Name of organization / entity
Royan Institute
Country
Iran (Islamic Republic of)
Phone
+98 21 2356 2000
Email address
nasser.aghdami@royaninstitute.org
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-03-14, 1395/12/24
Expected recruitment end date
2019-03-21, 1398/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of safety and efficacy of intra-articular transplantation of allogeneic adipose derived mesenchymal stromal cells in patients with knee joint osteoarthritis An interventional randomized triple-blind placebo controlled clinical trial phase I/II
Public title
Allogeneic stem cell transplantation in knee joint osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients in the range of 18 to 65 years old
osteoarthritis diagnosed by MRI
Exclusion criteria:
Pregnancy or lactating
Positive tests for HIV, HCV, HBV
Active central or peripheral neurologic disorder
End organ damage or Uncontrolled endocrine disorder
Active respiratory disorder and reaction to sedative drugs
history of cancer
Age
From 18 years old to 65 years old
Gender
Both
Phase
1-2
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Randomized allocation to intervention and control groups
Blinding (investigator's opinion)
Triple blinded
Blinding description
Participants would be allocated in case and control groups according to a confidential table of accidental numbers which will be just available for the lab responsible.
Care provider, investigator and outcome assessor are not aware of the substance which injected. In order to eliminate data analyzer's errors, group types would not be uncovered until the results are determined.
Placebo
Used
Assignment
Parallel
Other design features
Block randomization
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Royan infertility institute
Street address
Eastern Hafez St,Northern Banihashem St, 45 m Resalat highway
City
Tehran
Province
Tehran
Postal code
1665659911
Approval date
2017-10-10, 1396/07/18
Ethics committee reference number
IR.ACECR.ROYAN.REC.1396.138
Health conditions studied
1
Description of health condition studied
cell therapy in osteoarthritis
ICD-10 code
M15.9
ICD-10 code description
Polyosteoarthritis, unspecified
Primary outcomes
1
Description
Side effects
Timepoint
One week, one month, 3, 6 and 12 months after transplantation