Ankylosing SpondylitisPhase 1NCT07632599
Safety and Efficacy of Allogeneic Bone Marrow MSCs in Ankylosing Spondylitis
A Phase 1 study testing IV administration of CG-BM1 and CG-BM1 in people with Ankylosing Spondylitis, run by Eighth Affiliated Hospital, Sun Yat-sen University at 1 site in China.
Trial summary
The goal of this clinical trial is to learn if allogeneic human bone marrow-derived mesenchymal stem cells (CG-BM1) are safe and show preliminary efficacy in treating patients with ankylosing spondylitis (AS). It will also explore the appropriate dose of CG-BM1. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Ankylosing Spondylitis
- What is being tested?
- IV administration of CG-BM1 and CG-BM1
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2026to 1 Jun 2027
- Phase
- Phase 1
- 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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Meet the diagnostic criteria for ankylosing spondylitis (AS)
- Age 18 to 40 years
- Must be able to understand and communicate with the investigator, comply with study requirements, and provide signed and dated informed consent before any study assessments are performed
- Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) total score ≥ 4 (0-10 scale), and total back pain measured by VAS ≥ 40 mm (0-100 mm)
- CRP or ESR elevated ≥ 1.5 times the upper limit of normal
- Patients taking methotrexate (≤ 25 mg/week) or sulfasalazine (≤ 3 g/day) are permitted to continue these medications, provided they have been used for at least 3 months and maintained at a stable dose for at least 4 weeks prior to randomization. Patients taking methotrexate must maintain stable folic acid supplementation prior to randomization
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- Patients taking DMARDs other than methotrexate and sulfasalazine must discontinue them at least 4 weeks prior to randomization
- No prior use of any form of biologics within 6 months
- Spinal X-ray must rule out complete rigid ankylosis
Who cannot join
- Known allergy to any component of the study drug (primarily bone marrow mesenchymal stem cells; excipients include dimethyl sulfoxide, human albumin, etc.)
- Current evidence of infection or malignancy as shown by chest X-ray or MRI within 3 months prior to screening
- Currently using potent opioid analgesics
- Received any intra-articular injection therapy (e.g., corticosteroids) within 4 weeks prior to randomization
- Received any intramuscular corticosteroid injection within 2 weeks prior to randomization
- Received traditional Chinese medicine treatment for AS within 4 weeks prior to randomization
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- Pregnant or breastfeeding women
- Presence of underlying metabolic, hematologic, renal, hepatic, pulmonary, neurologic, endocrine, cardiac, infectious, or gastrointestinal disease that, in the investigator's opinion, would place the patient at unacceptable risk if treated with immunomodulatory agents
- Significant health problem or disease including (but not limited to): uncontrolled hypertension (≥ 160/95 mmHg), congestive heart failure, uncontrolled diabetes, or extremely poor functional status rendering the patient unable to care for themselves
- History of renal impairment, glomerulonephritis, or a single kidney, or serum creatinine level > 1.5 mg/dL
- Active systemic infection within 2 weeks prior to randomization (common cold excluded)
- Current infection or history of chronic, recurrent infectious disease, or clinical test suggesting tuberculosis (including latent tuberculosis)
- Known HIV infection, hepatitis B, or hepatitis C at screening or randomization
- History or evidence of alcohol or drug abuse within 6 months prior to randomization
- History of lymphoproliferative disease or known malignancy of any organ system within the past 5 years
- Pulmonary arterial hypertension class III or IV (WHO functional classification) at screening
- History of deep vein thrombosis at screening, or history of pulmonary embolism within 3 months prior to screening
- Any other condition that, in the investigator's opinion, makes the patient unsuitable for participation in the study (e.g., lack of compliance, difficulty in long-term follow-up)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The Eighth Affiliated Hospital, Sun Yat-sen University
Shenzhen, Guangdong, 518033
Prof. Chen, 86+83982222, sysuehoffice@mail.sysu.edu.cn
About this study
Official title: An Early Exploratory Clinical Study on the Safety and Preliminary Efficacy of Allogeneic Human Bone Marrow Mesenchymal Stem Cells in Patients With Ankylosing Spondylitis
The goal of this clinical trial is to learn if allogeneic human bone marrow-derived mesenchymal stem cells (CG-BM1) are safe and show preliminary efficacy in treating patients with ankylosing spondylitis (AS). It will also explore the appropriate dose of CG-BM1.
The main questions it aims to answer are:
Read more
What medical problems (adverse events) do participants have when taking CG-BM1? (Safety and tolerability)
Does CG-BM1 improve disease activity, pain, and function in patients with AS? (Preliminary efficacy)
Researchers will compare CG-BM1 to a placebo (an inactive substance that looks like CG-BM1) in the second phase of the study to see if CG-BM1 works for AS.
This study has two phases:
Phase 1 (dose-escalation): Open-label, single-arm. Participants will receive one of three escalating doses of CG-BM1 weekly for 4 weeks.
Phase 2 (dose-expansion): Randomized, double-blind, placebo-controlled. Participants will receive either the recommended dose of CG-BM1 or a placebo weekly for 4 weeks, in addition to standard background therapy (celecoxib).
Participants will:
Receive CG-BM1 or placebo via intravenous infusion once a week for 4 weeks
Visit the clinic for follow-up assessments at Week 1, 4, 8, 12, and 24 after the first infusion
Undergo physical exams, laboratory tests (blood and urine), and complete questionnaires about disease activity, pain, and function (e.g., BASDAI, VAS, ASAS response criteria)
- Conditions
- Ankylosing Spondylitis
- Being tested
- IV administration of CG-BM1, Placebo, CG-BM1
- Medical subject headings
- Spondylitis, Ankylosing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IV administration of CG-BM1Biological
Dose level 1: CG-BM1 1.0×10⁶ cells/kg, IV, weekly × 4 + celecoxib, 0.2g, p.o. daily Dose level 2: CG-BM1 2.0×10⁶ cells/kg, IV, weekly × 4 + celecoxib, 0.2g, p.o. daily Dose level 3: CG-BM1 4.0×10⁶ cells/kg, IV, weekly × 4 + celecoxib, 0.2g, p.o. daily
PlaceboBiological
Sodium Chloride Solution, 5 ml, IV, weekly × 4+ celecoxib, 0.2g, p.o. daily
CG-BM1Biological
CG-BM1 [recommended dose], IV, weekly × 4 + celecoxib, 0.2g, p.o. daily
| Study group | Role | What they receive |
|---|---|---|
| phase 1：CG-BM1 Dose Escalation Cohorts | Experimental | Participants will be sequentially assigned to one of three dose cohorts using a "3+3" design: low-dose (1*10^6 cells/kg), medium-dose (2.0*10^6 cells/kg), or high-dose 4.0*10^6 cells/kg). In each cohort, CG-BM1 will be administered via intravenous infusion once weekly for a total of 4 doses on Days 0, 7, 14, and 21. All participants across all cohorts will concurrently receive standard background therapy consisting of celecoxib 0.2g orally once daily. Receives: Biological: IV administration of CG-BM1 |
| phase 2 ：placebo Cohorts | Placebo comparator | Participants will be randomized to receive the placebo (Compound Electrolyte Injection) via intravenous (IV) infusion once weekly for a total of 4 doses, mimicking the regimen of the experimental group. All participants will simultaneously receive a background therapy of celecoxib 0.2g orally once daily. Receives: Biological: Placebo |
| phase 2 ：CG-BM1 Cohorts | Experimental | Participants will be randomized to receive CG-BM1 at the clinically recommended dose (determined by the Safety Review Committee based on Phase 1 results) via intravenous (IV) infusion once weekly for a total of 4 doses. All participants will simultaneously receive a background therapy of celecoxib 0.2g orally once daily. Receives: Biological: CG-BM1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Measured: 24 weeks
Incidence of Dose-Limiting Toxicities (DLTs)
Measured: 24 weeks
Secondary outcomes (11)
Percentage of Participants Achieving ASAS20 Response
ASAS20 response is defined as an improvement of > 20% and an absolute improvement of > 1 unit (on a 0-10 scale) or > 10 mm (on a 0-100 mm scale) in at least 3 of the following 4 domains: Patient Global Assessment, Physical Function (BASFI), Total Spinal Pain, and Inflammation (Morning Stiffness). Additionally, there must be no worsening in the remaining domain.
Measured: Weeks 1, 4, 8, 12, and 24
Global Assessment of Disease Activity
Evaluated using a 0-10 Visual Analog Scale (VAS), where 0 indicates "not active" and 10 indicates "very active". Higher scores represent greater disease activity. The outcome will report the change from baseline values at each subsequent visit timepoint.
Measured: Weeks 1, 4, 8, 12, and 24
Total Spinal Pain Intensity Score
Measured by a Visual Analog Scale (VAS) ranging from 0 mm (no pain) to 100 mm (severe pain), calculating the average score of overall spinal pain and nocturnal spinal pain over the past week. Higher scores represent worse pain intensity.
Measured: Weeks 1, 4, 8, 12, and 24
Bath Ankylosing Spondylitis Functional Index (BASFI)
BASFI consists of 10 items assessing the patient's ability to perform specific activities of daily living. Each item is scored on a 0-10 scale (0 = easy, 10 = impossible). The total score is calculated as the mean of the 10 scores, where a higher score indicates more severe functional impairment.
Measured: Weeks 1, 4, 8, 12, and 24
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
BASDAI evaluates 6 items: fatigue, spine pain, peripheral joint pain, localized tenderness, morning stiffness severity, and morning stiffness duration over the past week, each on a 0-10 scale. The final score is calculated as the average of the first 4 items plus the average of the two morning stiffness items, with a total range of 0 to 10. Higher scores indicate more severe disease activity.
Measured: Weeks 1, 4, 8, 12, and 24
Bath Ankylosing Spondylitis Metrology Index (BASMI)
BASMI evaluates spinal mobility based on 5 clinical measurements: cervical rotation, tragus-to-wall distance, lumbar flexion (modified Schober's test), lumbar side flexion, and intermalleolar distance. Each component is scored linearly from 0 to 2, with a total composite score ranging from 0 to 10. Higher scores indicate more severe impairment of spinal mobility.
Measured: Weeks 1, 4, 8, 12, and 24
Swollen Joint Count(SJC) and Tender Joint Count(TJC) Based on 44-Joint Assessment
Peripheral arthritis progression will be evaluated via the standard 44-joint count assessment. Scores range from 0 to 44 joints, where a reduction in count indicates therapeutic improvement.
Measured: Weeks 1, 4, 8, 12, and 24
Serum C-reactive Protein (CRP) Concentration (mg/L)
Evaluated via peripheral blood samples to explore the systemic anti-inflammatory effect of CG-BM1.
Measured: Weeks 1, 4, 8, 12, and 24
Erythrocyte Sedimentation Rate (ESR) (mm/h)
Evaluated via peripheral blood samples to explore the systemic anti-inflammatory effect of CG-BM1.
Measured: Weeks 1, 4, 8, 12, and 24
Serum Concentrations of Cytokines (TNF-α and BMP2) (pg/mL)
Measured via enzyme-linked immunosorbent assay (ELISA) from collected serum samples to investigate the mechanistic pathways of bone remodeling and immune regulation.
Measured: Weeks 1, 4, 8, 12, and 24
Peripheral Blood Immune Cell Subset Percentages
Evaluated via multicolour flow cytometry to quantify the percentages of CD4+ T cells, CD8+ T cells, Treg cells, Th17 cells, NK cells, MAIT cells, monocytes, neutrophils, and B cells relative to total lymphocytes or leukocytes, in order to track immune homeostasis reconstruction.
Measured: Weeks 1, 4, 8, 12, and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2026
- Study start1 Jul 2026 (estimated)
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jun 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eighth Affiliated Hospital, Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Collaborators
- GuangZhou Cellgenes Biotechnology Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07632599
- Sponsor's protocol ID
- MR-44-26-023756
- Status last verified
- May 2026
- First submitted
- 26 May 2026
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Early Exploratory Clinical Study on the Safety and Preliminary Efficacy of Allogeneic Human Bone Marrow Mesenchymal Stem Cells in Patients With Ankylosing Spondylitis
- ClinicalTrials.gov ID
- NCT07632599
- Acronym / sponsor ID
- MR-44-26-023756
- Conditions
- Ankylosing Spondylitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Eighth Affiliated Hospital, Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- GuangZhou Cellgenes Biotechnology Co., Ltd.
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 8 Jun 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 learn if allogeneic human bone marrow-derived mesenchymal stem cells (CG-BM1) are safe and show preliminary efficacy in treating patients with ankylosing spondylitis (AS). It will also explore the appropriate dose of CG-BM1.
The main questions it aims to answer are:
What medical problems (adverse events) do participants have when taking CG-BM1? (Safety and tolerability)
Does CG-BM1 improve disease activity, pain, and function in patients with AS? (Preliminary efficacy)
Researchers will compare CG-BM1 to a placebo (an inactive substance that looks like CG-BM1) in the second phase of the study to see if CG-BM1 works for AS.
This study has two phases:
Phase 1 (dose-escalation): Open-label, single-arm. Participants will receive one of three escalating doses of CG-BM1 weekly for 4 weeks.
Phase 2 (dose-expansion): Randomized, double-blind, placebo-controlled. Participants will receive either the recommended dose of CG-BM1 or a placebo weekly for 4 weeks, in addition to standard background therapy (celecoxib).
Participants will:
Receive CG-BM1 or placebo via intravenous infusion once a week for 4 weeks
Visit the clinic for follow-up assessments at Week 1, 4, 8, 12, and 24 after the first infusion
Undergo physical exams, laboratory tests (blood and urine), and complete questionnaires about disease activity, pain, and function (e.g., BASDAI, VAS, ASAS response criteria)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| phase 1：CG-BM1 Dose Escalation Cohorts | Experimental | Biological: IV administration of CG-BM1Participants will be sequentially assigned to one of three dose cohorts using a "3+3" design: low-dose (1*10^6 cells/kg), medium-dose (2.0*10^6 cells/kg), or high-dose 4.0*10^6 cells/kg). In each cohort, CG-BM1 will be administered via intravenous infusion once weekly for a total of 4 doses on Days 0, 7, 14, and 21. All participants across all cohorts will concurrently receive standard background therapy consisting of celecoxib 0.2g orally once daily. |
| phase 2 ：placebo Cohorts | Placebo comparator | Biological: PlaceboParticipants will be randomized to receive the placebo (Compound Electrolyte Injection) via intravenous (IV) infusion once weekly for a total of 4 doses, mimicking the regimen of the experimental group. All participants will simultaneously receive a background therapy of celecoxib 0.2g orally once daily. |
| phase 2 ：CG-BM1 Cohorts | Experimental | Biological: CG-BM1Participants will be randomized to receive CG-BM1 at the clinically recommended dose (determined by the Safety Review Committee based on Phase 1 results) via intravenous (IV) infusion once weekly for a total of 4 doses. All participants will simultaneously receive a background therapy of celecoxib 0.2g orally once daily. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Meet the diagnostic criteria for ankylosing spondylitis (AS)
- Age 18 to 40 years
- Must be able to understand and communicate with the investigator, comply with study requirements, and provide signed and dated informed consent before any study assessments are performed
- Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) total score ≥ 4 (0-10 scale), and total back pain measured by VAS ≥ 40 mm (0-100 mm)
- CRP or ESR elevated ≥ 1.5 times the upper limit of normal
Key exclusion criteria (18 listed)
- Known allergy to any component of the study drug (primarily bone marrow mesenchymal stem cells; excipients include dimethyl sulfoxide, human albumin, etc.)
- Current evidence of infection or malignancy as shown by chest X-ray or MRI within 3 months prior to screening
- Currently using potent opioid analgesics
- Received any intra-articular injection therapy (e.g., corticosteroids) within 4 weeks prior to randomization
- Received any intramuscular corticosteroid injection within 2 weeks prior to randomization
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 |
|---|---|---|
| IV administration of CG-BM1Dose level 1: CG-BM1 1.0×10⁶ cells/kg, IV, weekly × 4 + celecoxib, 0.2g, p.o. daily Dose level 2: CG-BM1 2.0×10⁶ cells/kg, IV, weekly × 4 + celecoxib, 0.2g, p.o. daily Dose level 3: CG-BM1 4.0×10⁶ cells/kg, IV, weekly × 4 + celecoxib, 0.2g, p.o. daily | Biological | phase 1：CG-BM1 Dose Escalation Cohorts |
| PlaceboSodium Chloride Solution, 5 ml, IV, weekly × 4+ celecoxib, 0.2g, p.o. daily | Biological | phase 2 ：placebo Cohorts |
| CG-BM1CG-BM1 [recommended dose], IV, weekly × 4 + celecoxib, 0.2g, p.o. daily | Biological | phase 2 ：CG-BM1 Cohorts |
Primary outcome
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: 24 weeks
Incidence of Dose-Limiting Toxicities (DLTs)
Time frame: 24 weeks
11 secondary outcomes
Percentage of Participants Achieving ASAS20 Response
Time frame: Weeks 1, 4, 8, 12, and 24
Global Assessment of Disease Activity
Time frame: Weeks 1, 4, 8, 12, and 24
Total Spinal Pain Intensity Score
Time frame: Weeks 1, 4, 8, 12, and 24
Bath Ankylosing Spondylitis Functional Index (BASFI)
Time frame: Weeks 1, 4, 8, 12, and 24
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Time frame: Weeks 1, 4, 8, 12, and 24
Bath Ankylosing Spondylitis Metrology Index (BASMI)
Time frame: Weeks 1, 4, 8, 12, and 24
Swollen Joint Count(SJC) and Tender Joint Count(TJC) Based on 44-Joint Assessment
Time frame: Weeks 1, 4, 8, 12, and 24
Serum C-reactive Protein (CRP) Concentration (mg/L)
Time frame: Weeks 1, 4, 8, 12, and 24
Erythrocyte Sedimentation Rate (ESR) (mm/h)
Time frame: Weeks 1, 4, 8, 12, and 24
Serum Concentrations of Cytokines (TNF-α and BMP2) (pg/mL)
Time frame: Weeks 1, 4, 8, 12, and 24
Peripheral Blood Immune Cell Subset Percentages
Time frame: Weeks 1, 4, 8, 12, and 24
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 8 Jun 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing IV administration of CG-BM1 and CG-BM1 in people with Ankylosing Spondylitis, run by Eighth Affiliated Hospital, Sun Yat-sen University at 1 site in China.
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 9 inclusion and 18 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 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this 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.
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?
Contact Prof.Wang (86+138 2602 4785, wangp57@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) (time frame: 24 weeks). The study lists 2 primary outcomes in all. 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 8 Jun 2026.