A Phase I/Ⅱ Clinical Trial for Umbilical Cord Mesenchymal Stem Cells (UC-MSC) in the Treatment of… (NCT07534644) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
A Phase I/â…¡ Clinical Trial for Umbilical Cord Mesenchymal Stem Cells (UC-MSC) in the Treatment of Ankylosing Spondylitis
18 participantsStarted 2026-04-10
Plain-language summary
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.
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. 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.
✓. Participants must have received conventional therapy and, prior to randomization, must meet at least one of the following criteria for the following criteria, as confirmed by the investigator: (a) inadequate response to nonsteroidal anti-inflammatory drugs (NSAIDs): ≥4 weeks of continuous therapeutic-dose NSAID if one agent used; or ≥2 weeks of therapeutic-dose NSAID for each of ≥2 agents; (b) intolerance to NSAIDs: Discontinuation of NSAIDs due to treatment-related adverse events (e.g., allergic reactions, gastrointestinal symptoms or signs); the 4-week treatment duration is not required. (c) Contraindication to NSAID therapy: History of NSAID allergy, active gastrointestinal ulcer, bleeding, or other contraindications.
✓. Participants who have previously received at least two biologic disease-modifying antirheumatic drugs (bDMARDs) must have received recommended doses for at least 12 weeks prior to randomization with inadequate response, or have been intolerant to at least one bDMARD treatment (e.g., unable to continue due to adverse drug reactions, allergic reactions, or other reasons).
. Participants receiving concomitant oral corticosteroids or NSAIDs must be on a stable dose for at least 14 days before the baseline visit. Participants receiving conventional synthetic DMARDs (cDMARDs) must be on a stable dose for at least 28 days prior to the baseline visit.
✓. Female participants must: Be of non-childbearing potential, defined as postmenopausal for at least 1 year or surgically sterilized; OR, If of childbearing potential, agree to use strict contraceptive measures from the time of signed informed consent through at least 6 months after the last dose of study drug, and have a negative serum pregnancy test at screening.
Exclusion criteria
✕. 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;
✕. Participation in another clinical trial within 3 months prior to screening, or planned participation in another clinical trial;
✕. Severe infection indicated by clinical and radiological data; patients positive for HIV, hepatitis C, syphilis, etc.; patients with tumors or a tendency to develop tumors; patients with severe cardiac, pulmonary, hepatic, renal, hematologic, endocrine, or other systemic diseases; patients with epilepsy or psychiatric disorders;
✕. Received mesenchymal stem cell therapy within less than 3 months prior to screening;
✕. Breastfeeding women, women planning to become pregnant during the study period, or men planning to father a child;