Ankylosing Spondylitis, autoimmunity. Ankylosing spondylitis
Conditions
Interventions
Intervention 1: Intervention group 1: 100 cc of normal saline containing mesenchymal cells at the rate of one million cells per kilogram of the patients body weight. The type of injection is intraveno
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 co
Sponsors
Tehran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
30 Years to 55 Years
Inclusion 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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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.;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.;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.;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.;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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactNarjes Soleimanifar
Tehran University of Medical Sciences
Outcome results
None listed