Safety and Tolerance of Umbilical Cord Mesenchymal Stem Cells (UC-MSC) in Patients With Ankylosing Spondylitis

Korábbi kezelés

• 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
• 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;
• Previously treated with stem cell therapy;
• 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;

Más betegség

• Those with hypersensitivity to known components of the test drug, or a history of severe allergy.
• 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);
• Subjects with any other irreversible condition or symptom with an expected survival of <3 months
• Any other condition that, in the judgment of the investigator, makes them unsuitable for participation in this trial.

Laborértékek

• 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%.

Egyéb

• Those with complete spinal rigidity;
• Lactating females or females with positive blood pregnancy test results at screening/baseline

• 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.