Ankylosing SpondylitisPhase 1/2HS_SW01NCT07534644
A Phase I/Ⅱ Clinical Trial for Umbilical Cord Mesenchymal Stem Cells (UC-MSC) in the Treatment of Ankylosing Spondylitis
A Phase 1/2 study testing HS_SW01 cells injection in people with Ankylosing Spondylitis, run by Shenzhen Huishan Biotechnology Co., Ltd..
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Ankylosing Spondylitis
- What is being tested?
- HS_SW01 cells injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- No sites listed yet
- Study dates
- 10 Apr 2026to 31 Dec 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
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- 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.
Who cannot join
- 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;
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- 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:
- 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;
- Cerebrovascular or cardiovascular event within 3 months prior to dosing (myocardial infarction, ischemic or hemorrhagic stroke (excluding lacunar infarction), severe arrhythmia, deep vein thrombosis, etc.);
- Any clinically significant respiratory disease, including but not limited to chronic obstructive pulmonary disease, asthma, interstitial pneumonia, bronchiectasis, pleural effusion;
- History of demyelinating disease or clinical suspicion of such disease, including but not limited to multiple sclerosis, Guillain-Barré syndrome;
- Unstable diabetes mellitus without stable dosing control within 4 weeks prior to screening (HbA1c < 6.5% at screening);
- Other inflammatory arthritis or rheumatic diseases (other than AS) that may affect the evaluation of clinical efficacy, including but not limited to rheumatoid arthritis, psoriatic arthritis, systemic lupus erythematosus, gouty arthritis;
- Any neurological, psychiatric, or other systemic disease that may affect the evaluation of clinical efficacy;
- History of malignancy within the past 5 years (excluding cured non-metastatic cutaneous squamous cell carcinoma, basal cell carcinoma, or cervical carcinoma in situ);
- History of lymphoma or lymphoproliferative disease; 14.Concomitant use of the following medications:
- Use of glucocorticoids, except for oral prednisone at a daily dose ≤ 10 mg or equivalent dose of other corticosteroids, with the dose stable for at least 4 weeks; (2) Patients who discontinued leflunomide and received cholestyramine (8 g three times daily) for 2 weeks must have a 4-week washout period before screening. Patients who discontinued leflunomide without taking cholestyramine must have a 12-week washout period from the last dose of leflunomide to screening; (3) Use of alkylating agents within 12 months prior to screening; (4) Intra-articular, intramuscular, or intravenous injection of corticosteroids within 4 weeks prior to screening; 15.The investigator considers the patient unsuitable for enrollment in this trial.
About this study
Official title: A Phase I/Ⅱ Clinical Trial for HS_SW01 Cells Injection in the Treatment of Ankylosing Spondylitis
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.
Read the detailed description
This clinical trial is a multicenter Phase I/II clinical trial, which includes two stages: Phase I dose-escalation and Phase II dose-expansion. The Phase I dose-escalation stage adopts a single-arm design and aims to evaluate the safety, tolerability and preliminary efficacy of HS_SW01 cells injection in patients with Ankylosing Spondylitis. The Phase II dose-expansion stage is a randomized, double-blind, controlled study designed to evaluate the safety and efficacy of HS_SW01 cells injection in patients with Ankylosing Spondylitis.
During the Phase I, the trial includes three dose groups: 1.0×10^6 cells/kg, 2.0×10^6 cells/kg and 2.0×10^6 cells/kg. Using a "3+3" dose-escalation design, each dose group will enroll 4 to 7 subjects in sequential order from the lowest to the highest dose level.
Eligible participants are patients with Ankylosing Spondylitis between 18 and 65 years of age inclusive, who satisfy all the inclusion criteria and do not meet any of the exclusion criteria.
- Conditions
- Ankylosing Spondylitis
- Being tested
- HS_SW01 cells injection
- Keywords
- Ankylosing Spondylitis, MSC
- Medical subject headings
- Spondylitis, Ankylosing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HS_SW01 cells injectionDrug
HS_SW01 cells injection will be given as a single intravenous infusion.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: HS_SW01 cells injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of DLT
Incidence of dose-limiting toxicities (DLTs) within 28 days following study drug administration.
Measured: Within 28 Days
Secondary outcomes (1)
ASAS20 response rate post-treatment
Percentage of participants achieving ASAS20 response at Week 12 after administration.
Measured: baseline, Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2026
- Study start10 Apr 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ankylosing SpondylitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shenzhen Huishan Biotechnology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Southern Medical University, China
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07534644
- Sponsor's protocol ID
- HS_SW01-AS
- Acronym
- HS_SW01
- Status last verified
- Apr 2026
- First submitted
- 10 Apr 2026
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/Ⅱ Clinical Trial for HS_SW01 Cells Injection in the Treatment of Ankylosing Spondylitis
- ClinicalTrials.gov ID
- NCT07534644
- Acronym / sponsor ID
- HS_SW01 / HS_SW01-AS
- Conditions
- Ankylosing Spondylitis
- Keywords
- Ankylosing Spondylitis, MSC
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Shenzhen Huishan Biotechnology Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Southern Medical University, China
- Study start
- 10 Apr 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 16 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This clinical trial is a multicenter Phase I/II clinical trial, which includes two stages: Phase I dose-escalation and Phase II dose-expansion. The Phase I dose-escalation stage adopts a single-arm design and aims to evaluate the safety, tolerability and preliminary efficacy of HS_SW01 cells injection in patients with Ankylosing Spondylitis. The Phase II dose-expansion stage is a randomized, double-blind, controlled study designed to evaluate the safety and efficacy of HS_SW01 cells injection in patients with Ankylosing Spondylitis.
During the Phase I, the trial includes three dose groups: 1.0×10^6 cells/kg, 2.0×10^6 cells/kg and 2.0×10^6 cells/kg. Using a "3+3" dose-escalation design, each dose group will enroll 4 to 7 subjects in sequential order from the lowest to the highest dose level.
Eligible participants are patients with Ankylosing Spondylitis between 18 and 65 years of age inclusive, who satisfy all the inclusion criteria and do not meet any of the exclusion criteria.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| intravenous inject MSCs | Experimental | Drug: HS_SW01 cells injectionThe 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 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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.
Key exclusion criteria (24 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HS_SW01 cells injectionHS_SW01 cells injection will be given as a single intravenous infusion. | Drug | intravenous inject MSCs |
Primary outcome
The incidence of DLT
Time frame: Within 28 Days
Incidence of dose-limiting toxicities (DLTs) within 28 days following study drug administration.
1 secondary outcome
ASAS20 response rate post-treatment
Time frame: baseline, Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing HS_SW01 cells injection in people with Ankylosing Spondylitis, run by Shenzhen Huishan Biotechnology Co., Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of DLT (time frame: Within 28 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2026.