The goal of this clinical trial is to evaluate the safety and tolerability of multiple doses of human umbilical cord mesenchymal stem cell injection in patients with Ankylosing Spondylitis, and to further explore the efficacy, pharmacodynamic profile and appropriate dose of administration to provide a basis for the use of safer and more effective treatments for patients with Ankylosing Spondylitis in the future.
Participants are required to sign an informed consent form and, after undergoing a series of tests and meeting the protocol's entry and exclusion criteria, are assigned to a dose group for intravenous infusion of human umbilical cord mesenchymal stem cells.
A definitive diagnosis of ankylosing spondylitis (AS) (according to the 1984 New York Revised Criteria, Annex 1) with active AS. Active AS is defined as a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of ≥4. Active AS is defined as a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of ≥4;
Received at least 2 non-steroidal anti-inflammatory drugs (NSAIDs) for a total of 4 weeks or more prior to screening. Patients who received at least 2 NSAIDs for a total of 4 weeks or more without significant improvement in symptoms as evaluated by the investigator or who were intolerant; if Patients receiving salazosulfapyridine and/or methotrexate should have been on treatment for at least 3 months or longer and on a stable dose for at least 4 weeks or more prior to enrollment. If the patient is receiving salazosulfapyridine and/or methotrexate, the length of treatment prior to enrollment should be at least 3 months and longer and the stable dose at least 4 weeks and longer;
If the patient is receiving glucocorticosteroid therapy, stabilization for at least 4 weeks prior to enrollment to a dose equivalent to ≤ 10 mg of prednisone/day;
Patients and spouses who do not plan to have children within 1 week prior to screening and within 6 months after the end of the trial and who agree to to use effective non-pharmacological contraception during the trial;
Those with complete spinal rigidity;
Those with hypersensitivity to known components of the test drug, or a history of severe allergy.
Persons with a history of any malignancy (except basal cell carcinoma of the skin, carcinoma in situ) within 5 years prior to dosing
Persons with a cardiovascular or cerebrovascular event (heart attack, ischemic or hemorrhagic stroke (except lacunar cerebral infarction), severe cardiac arrhythmia, deep vein thrombosis, etc.) within 3 months prior to dosing
Asia Cell Therapeutics (Shanghai) Co., Ltd.
Lead sponsor
RenJi Hospital
Collaborator