Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 9:40 PM
Ignite Modification Date:
2025-12-24 @ 9:40 PM
NCT ID:
NCT01420432
Eligibility Criteria:
Inclusion Criteria:
1. Patient age 18\~60 years old with plan to infuse MSCs.
2. Diagnosis of "Definite AS" (arthritis of the spine) as defined by the modified New York criteria
3. Stable doses of sulfasalazine,methotrexate,thalidomide,hydroxychloroquine, low-dose corticosteroids, and NSAIDs are permitted
4. Patients must have an ECOG 0\~2.
5. No moderate or sever organ dysfunction: Ejection fraction\>45%; Creatinine \<176 umol/L.
6. No severe infection.
7. Each patient must sign written informed consent.
Exclusion Criteria:
1. Other serious concomitant diseases (uncontrolled/severe kidney, liver, haematological, gastrointestinal, endocrine, cardiovascular, pulmonary, neurological or cerebral disease)
2. Psychiatric condition that would limit informed consent.
3. HIV, hepatitis B or C, tuberculosis, other infections
4. Positive Pregnancy Test or lactation
5. Patient has enrolled another clinical trial study within last 4 weeks.
6. Contraindications to MSC
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
60 Years
Study:
NCT01420432
Study Brief:
Protocol Section:
NCT01420432