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Evaluation of umbilical cord-derived mesenchymal stem cells (UC-MSCs) transplantation efficacy in the treatment of ankylosing spondylitis (AS)

Protocol summary

Study aim
Evaluation of the efficacy of allogenic umbilical cord-derived mesenchymal stem cell transplantation in the treatment of ankylosing spondylitis (AS).
Design
A randomized, double blinded, clinical trial with two control groups design of 15 patients, enrolled between september 2024 and September 2025, and followed for one year.
Settings and conduct
Molecular Immunology research center cooperating with rheumatology section in Imam Khomeini Hospital
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1- Subscribe voluntarily to the agreement approved by Ethics Committees and sign the date. 2- Patient aged 30 to 55 years.3- Fulfill 1984 modified NewYork classification criteria for AS according to BASG, BASMI, BASFI, BASDAI and ASQoL. 4- The score of the Bath AS Disease Activity Index (BASDAI)≥4. Exclusion criteria: 1- Completely stiff spine; 2- Patients with the Medical or mentally imbalance charged by researchers. patients associated cardiovascular, cerebrovascular, liver, renal, malignancies and COPD; 3- HIV, hepatitis B or C, tuberculosis, other infections; 4- Psychiatric condition that would limit informed consent.; 5- Pregnancy or breast feeding; 6- Contraindications to MSCs; 7- Received spinal or joint surgery within 2 months.
Intervention groups
Intervention group: the patients who get the mesenchymal stem cells. Control group 1: the patients who get 100 cc normal saline as a placebo. Control group 2: the patients who have no intervention.
Main outcome variables
BASFI; BASDAI; BASMI; ESR; CRP; and MRI.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240618062167N1
Registration date: 2024-09-18, 1403/06/28
Registration timing: prospective

Last update: 2024-09-18, 1403/06/28
Update count: 0
Registration date
2024-09-18, 1403/06/28
Registrant information
Name
Narjes Soleimanifar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6694 4508
Email address
n-soleimanifar@sina.tums.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2024-09-22, 1403/07/01
Expected recruitment end date
2025-06-22, 1404/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of umbilical cord-derived mesenchymal stem cells (UC-MSCs) transplantation efficacy in the treatment of ankylosing spondylitis (AS)
Public title
The effectiveness of cell therapy on Ankylosing Spondylitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Fulfill the informed consent Age between 30-55 years The definitive diagnosis of AS is based on1984 modified New York criteria, taking into account the patient's symptoms, clinical examination, laboratory results, and radiological findings, and according to the indices of BASG, BASMI, BASFI, BASDAI, and ASQoL, provided that they are in the inflammatory phase of the disease. Disease activity: having a minimum score of 4 in the BASDAI questionnaires
Exclusion criteria:
Completely stiff spine Patients with the Medical or mentally imbalance charged by researchers. patients associated cardiovascular, cerebrovascular, liver (Cirrhosis) ,renal, malignancies and COPD Psychiatric disorder that prevents obtaining informed consent." Pregnancy or breastfeeding Contraindications to MSC HIV, hepatitis B or C Joint or spine surgery in the last 2 months
Age
From 30 years old to 55 years old
Gender
Both
Phase
2
Groups that have been masked
  • Participant
Sample size
Target sample size: 15
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
The participants are not aware of intervention process.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Children Medical Center Tehran University of Medical Sciences Ethics Committee
Street address
Gharib Ave, Keshavars Blvd, Tehran
City
Tehran
Province
Tehran
Postal code
1419733151
Approval date
2024-05-13, 1403/02/24
Ethics committee reference number
IR.TUMS.CHMC.REC.1403.049

Health conditions studied

1

Description of health condition studied
Ankylosing Spondylitis, autoimmunity
ICD-10 code
M45
ICD-10 code description
Ankylosing spondylitis

Primary outcomes

1

Description
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Timepoint
Patients will be evaluated once before the injection for initial assessment and three times after the injection (at specified intervals of one week, one month, and three months) regarding the following items
Method of measurement
Filling the questionnaire

2

Description
Bath Ankylosing Spondylitis Functional Index (BASFI)
Timepoint
Patients will be evaluated once before the injection for initial assessment and three times after the injection (at specified intervals of one week, one month, and three months) regarding the following items.
Method of measurement
filling the questionnaire

3

Description
Bath Ankylosing Spondylitis Metrology Index (BASMI)
Timepoint
Patients will be evaluated once before the injection for initial assessment and three times after the injection (at specified intervals of one week, one month, and three months) regarding the following items.
Method of measurement
Measuring the movement restrictions by specialist

4

Description
The Ankylosing Spondylitis Quality of Life (ASQoL)
Timepoint
Patients will be evaluated once before the injection for initial assessment and three times after the injection (at specified intervals of one week, one month, and three months) regarding the following items.
Method of measurement
Filling the questionnaire

5

Description
C reactive protein (CRP)
Timepoint
Patients will be evaluated once before the injection for initial assessment and three times after the injection (at specified intervals of one week, one month, and three months) regarding the following items.
Method of measurement
Laboratory test

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group 1: 100 cc of normal saline containing mesenchymal cells at the rate of one million cells per kilogram of the patient's body weight. The type of injection is intravenous. Patients will not be deprived of the usual initial treatment of NSAIDs or DMARDS. The second round will take place two weeks after the first injection with the conditions mentioned in the first round.
Category
Treatment - Other

2

Description
Control group 1: receives 100 cc of normal saline as a placebo; the type of injection is intravenous. Patients will not be deprived of the usual initial treatment of NSAIDs or DMARDS. The second round will take place two weeks after the first injection with the conditions mentioned in the first round.
Category
Placebo

3

Description
Control group 2: there is no intervention. the clinical data of patients who are under biologic treatments would be collected.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini medical Hospital
Full name of responsible person
Abdorahman Rostamian
Street address
Keshavrz Blvd, Gharib Ave, Tehran
City
Tehran
Province
Tehran
Postal code
1419733151
Phone
+98 21 6694 4508
Email
rostamianar@sina.tums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ali Akbari Sari
Street address
Quds st., Keshavarz blvd.
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 81631
Email
tumspr@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Narjes Soleimanifar
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Molecular Medicine
Street address
No142, Nosrat St, North Jamalzadeh, Tehran
City
Tehran
Province
Tehran
Postal code
1419853772
Phone
+98 21 6694 4508
Email
n-soleimanifar@sina.tums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Narjes Soleimanifar
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Molecular Medicine
Street address
No.142, Nosrat St, North Jamalzadeh Ave., Tehran
City
Tehran
Province
Tehran
Postal code
1419853772
Phone
+98 21 6694 4508
Email
n-soleimanifar@sina.tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammadali Zolfaghari
Position
Colleague
Latest degree
Ph.D.
Other areas of specialty/work
Molecular Medicine
Street address
No. 142, Nosrat St, North Jamalzade Ave., Tehran
City
Tehran
Province
Tehran
Postal code
1419853772
Phone
009866944508
Email
mzolfaghari@tbzmed.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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