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
Sequential
Human Umbilical Cord Mesenchymal Stem Cells
Biological/VaccineThe trial was conducted sequentially from the low dose group to the high dose group, with 3-6 subjects enrolled in each dose group. The trial was conducted on a case-by-case basis in the high dose group, with each subject in the high dose group being enrolled in subsequent subjects only after completion of at least 7 days of post-dose safety observation. Each subject received only one corresponding dose. All subjects received experimental drugs and conventional treatment during the study period. All subjects in each test dose group will complete a 4-week (28-day) dose-limiting toxicity (DLT) After the observational evaluation period, a decision will be made by the investigator and sponsor based on a discussion of relevant safety data whether to start the next dose group.
Adverse Event (AE)
Incidence and severity of any adverse events related to the treatment of the trial drug that occurred during the clinical trial
Maximum tolerated dose (MTD)
Explore the MTD after administration of the test drug
Improvement of Assessment in ankylosingspondylitis 20 (ASAS20)
The ASAS Response Criteria (ASAS 20) is defined as an improvement of at least 20% and an absolute improvement of at least 10 units on a 0-100 scale in at least three of the following domains: Patient global assessment, Pain assessment, Function, and Inflammation.
Improvement of Assessment in ankylosingspondylitis 50 (ASAS50)
The ASAS Response Criteria (ASAS 20) is defined as an improvement of at least 50% and an absolute improvement of at least 10 units on a 0-100 scale in at least three of the following domains: Patient global assessment, Pain assessment, Function, and Inflammation.
Change of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
BASDAI is the most widely used measure of disease activity in axial spinal arthritis (axSpA) and includes the assessment of fatigue, overall low back pain, pain and swelling of peripheral joints, attachment inflammation, severity of morning stiffness discomfort, and duration of morning stiffness. This score is used to compare patients' improvement from baseline. The higher the score is, the more severe the disease is.
Change of Bath Ankylosing Spondylitis Functional Index (BASFI)
BASFI is a scoring measure used to assess the status of their physical function, which relates to the activity performance and functional ability of patients with AS in daily life. This score is used to compare patients' improvement from baseline. The higher the score is, the more severe the disease is.
Interleukin-2 (IL-2)
The concentration of IL-2
Interleukin-6 (IL-6)
The concentration of IL-6
Interleukin-17 (IL-17)
The concentration of IL-17
Interleukin-22 (IL-22)
The concentration of IL-22
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Asia Cell Therapeutics (Shanghai) Co., Ltd.
Lead sponsor
RenJi Hospital
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
