A Phase I/Ⅱ Clinical Trial for HS_SW01 Cells Injection in the Treatment of Ankylosing Spondylitis

NCT07534644 | Not Yet Recruiting Phase 1

• 1 other identifier: HS_SW01-AS
• Study Type: interventional
• Target: 18
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Ankylosing Spondylitis

Keywords

Ankylosing Spondylitis; MSC

Outcome Measures

Primary Outcomes (1)

• The incidence of DLT

  Incidence of dose-limiting toxicities (DLTs) within 28 days following study drug administration.

  Within 28 Days

Secondary Outcomes (1)

• ASAS20 response rate post-treatment

  baseline, Week 12

Study Arms (1)

intravenous inject MSCs

EXPERIMENTAL

The trial was divided into three dose groups： Low-dose group: 1.0×10\^6 cells/kg; Medium-dose group: 2.0×10\^6 cells/kg; High-does group: 3.0×10\^6 cells/kg

Drug: HS_SW01 cells injection

Interventions

HS_SW01 cells injection DRUG

HS\_SW01 cells injection will be given as a single intravenous infusion.

intravenous inject MSCs

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Participants must be considered in good general health based on medical history and physical examination performed at screening, as judged by the investigator.
• Participants must voluntarily agree to receive disease education and be willing to maintain correct posture and perform appropriate physical exercise.
• Participants must be willing and able to complete all study procedures and follow-up visits.

You may not qualify if:

• 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;
• Significant laboratory abnormalities:
• (1) Hemoglobin \< 90 g/L in males, \< 85 g/L in females; (2) White blood cell count \< 3 × 10\^9/L; (3) Platelet count \< 90 × 10\^9/L; (4) AST or ALT \> twice the upper limit of normal; (5) Other laboratory results considered markedly abnormal by the investigator; 10.Presence of active infection, including acute, chronic, or local infections (e.g., sepsis, abscess, opportunistic infection, invasive fungal infection, etc.); 11.Oral antibiotic use within 2 weeks prior to screening, or intramuscular/intravenous antibiotic treatment for infection within 4 weeks prior to screening, or a history of severe infection within 6 months prior to screening (the investigator should assess the potential risk of enrollment based on individual clinical history); 12.History of recurrent herpes zoster, history of Listeria infection, history of reticuloendothelial fungal disease, or other chronic or recurrent infections; 13.Presence of one or more of the following conditions:
• Inability to perform activities of daily living, requiring a wheelchair or bedridden due to limited mobility;
• Severe cardiac, pulmonary, hepatic, or renal dysfunction;
• Uncontrolled hypertension (150/100 mmHg);
• History of congestive heart failure (New York Heart Association Class III/IV);
• History of acute myocardial infarction or unstable angina within 12 months prior to screening;

Sponsors & Collaborators

• Shenzhen Huishan Biotechnology Co., Ltd.: lead
• Southern Medical University, China: collaborator
• The Second Affiliated Hospital of Guangzhou University of Chinese Medicine: collaborator

MeSH Terms

Conditions

Spondylitis, Ankylosing

Condition Hierarchy (Ancestors)

Axial Spondyloarthritis; Spondylarthropathies; Spondylarthritis; Spondylitis; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Ankylosis; Joint Diseases; Arthritis

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2026
• First Posted: April 16, 2026
• Study Start: April 10, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share