Status:
NOT_YET_RECRUITING
Safety and Tolerance of Umbilical Cord Mesenchymal Stem Cells (UC-MSC) in Patients With Ankylosing Spondylitis
Lead Sponsor:
Asia Cell Therapeutics (Shanghai) Co., Ltd.
Collaborating Sponsors:
RenJi Hospital
Conditions:
Ankylosing Spondylitis
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief Summary
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 fur...
Detailed Description
Ankylosing spondylitis (AS) is an inflammatory disease of unknown origin that mainly affects the sacroiliac joints, spinal prominences, paraspinal soft tissues and peripheral joints, and may be accomp...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
August 30 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT05962762
Start Date
August 30 2023
End Date
December 31 2027
Last Update
August 15 2023
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