Clinical Research Directory

Inclusion Criteria: * 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; * Patients voluntarily signed an informed consent form and were willing to cooperate with the trial process. Note: CT findings may be accepted if the diagnosis is not clear on x-ray. Exclusion Criteria: * 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 * Those who have had a serious infection or have an active infection requiring intravenous antibiotic treatment within 4 weeks prior to screening * Lactating females or females with positive blood pregnancy test results at screening/baseline * Persons with known human immunodeficiency virus infection or impaired immune function or infectious disease (e.g. HBsAg positive, HBcAb positive with HBV-DNA titer \> 1000 IU/ml, HCV-Ab, HIV-Ab, syphilis test (TRUST), tuberculosis test (T-SPOT.TB) positive); * Patients who have participated in other clinical trials or studies within 2 months prior to dosing; * Those who have been treated with TNF-alpha antagonists or other biological agents within 3 months prior to dosing * Those who have received DMARDs class drugs within 1 month prior to dosing (except for those treated with salazosulfapyridine or methotrexate for 3 months or more prior to screening and at a stable dose for at least 4 weeks or more) with leflunomide discontinuation \<8 weeks; or those with discontinuation time \<7 drug half-lives depending on the actual drug class (i.e. DMARDs class drug elution period should exceed 7 half-lives of the corresponding drug), whichever is longer; * Those whose screening or baseline phase examination meets any of the following: Glutamic aminotransferase (AST) or glutamic alanine aminotransferase (ALT) \> 2.5 x ULN (non-hepatic source excluded); Serum creatinine \> 1.5 x ULN or glomerular filtration rate a \< 60 mL/min/1.73 m2; Activated partial thromboplastin time (APTT) \>1.5×ULN or prothrombin time (PT) \> 2.5 x ULN (not receiving anticoagulation); Left ventricular ejection fraction ≤ 45%. * Previously treated with stem cell therapy; * Subjects with any other irreversible condition or symptom with an expected survival of \<3 months * Those who have undergone spinal or joint surgery within 2 months prior to dosing; * History of alcoholism, mental illness, drug abuse, or use of any drug within 12 months prior to administration; * Any other condition that, in the judgment of the investigator, makes them unsuitable for participation in this trial.