The goal of this clinical trial is to evaluate the safety, tolerability and efficacy of human umbilical cord mesenchymal stem cell injection (HS\_SW01 cells injection) in patients with Ankylosing Spondylitis.
Participants will be required to sign the informed consent form and will only be assigned to the study and enrolled after undergoing a series of tests and meeting the inclusion and exclusion criteria of the protocol.
Age 18 to 65 years, inclusive, male or female.
Voluntarily sign the informed consent form and comply with the requirements of this study protocol.
Participants must have a documented diagnosis of ankylosing spondylitis (AS) based on the modified 1984 New York criteria, as follows: (a) Inflammatory back pain for ≥3 months, improving with activity but not relieved by rest;; (b) Limited spinal motion in the lumbar spine (sagittal and frontal planes); (c) chest expansion reduced relative to normal values for age and sex. (d):Sacroiliitis on imaging: bilateral grade II-IV or unilateral grade III-IV. Diagnosis of AS requires fulfillment of criterion (d) plus any one of criteria (a)-(c). The diagnosis must be confirmed at both the screening and baseline visits.
Participants must have active AS at screening and baseline, defined as Ankylosing Spondylitis Disease Activity Score (ASDAS) ≥2.1, or Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) ≥4.
Hypersensitivity to any component of this product;
History of significant drug abuse or alcohol dependence currently or within the past 2 years;
Complete rigidity of the spine in the trial participant;
Undergone bone/joint/synovectomy surgery within 3 months prior to screening, or planned to undergo joint or spinal surgery during the trial period;
Shenzhen Huishan Biotechnology Co., Ltd.
Lead sponsor
Southern Medical University, China
Collaborator