Safety and Efficacy of Allogeneic Bone Marrow MSCs in Ankylosing Spondylitis

June 2, 2026 updated by: Eighth Affiliated Hospital, Sun Yat-sen University

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:

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Guangdong
      • Shenzhen, Guangdong, China, 518033

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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
  • 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

Exclusion Criteria:

  • 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
  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: phase 1：CG-BM1 Dose Escalation Cohorts
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.
Biological: IV administration of CG-BM1
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
Placebo Comparator: phase 2 ：placebo Cohorts
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.
Biological: Placebo
Sodium Chloride Solution, 5 ml, IV, weekly × 4+ celecoxib, 0.2g, p.o. daily
Experimental: phase 2 ：CG-BM1 Cohorts
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.
Biological: CG-BM1
CG-BM1 [recommended dose], IV, weekly × 4 + celecoxib, 0.2g, p.o. daily

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame: 24 weeks
24 weeks
Incidence of Dose-Limiting Toxicities (DLTs)
Time Frame: 24 weeks
24 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants Achieving ASAS20 Response
Time Frame: Weeks 1, 4, 8, 12, and 24
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.
Weeks 1, 4, 8, 12, and 24
Global Assessment of Disease Activity
Time Frame: Weeks 1, 4, 8, 12, and 24
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.
Weeks 1, 4, 8, 12, and 24
Total Spinal Pain Intensity Score
Time Frame: Weeks 1, 4, 8, 12, and 24
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.
Weeks 1, 4, 8, 12, and 24
Bath Ankylosing Spondylitis Functional Index (BASFI)
Time Frame: Weeks 1, 4, 8, 12, and 24
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.
Weeks 1, 4, 8, 12, and 24
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Time Frame: Weeks 1, 4, 8, 12, and 24
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.
Weeks 1, 4, 8, 12, and 24
Bath Ankylosing Spondylitis Metrology Index (BASMI)
Time Frame: Weeks 1, 4, 8, 12, and 24
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.
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
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.
Weeks 1, 4, 8, 12, and 24
Serum C-reactive Protein (CRP) Concentration (mg/L)
Time Frame: Weeks 1, 4, 8, 12, and 24
Evaluated via peripheral blood samples to explore the systemic anti-inflammatory effect of CG-BM1.
Weeks 1, 4, 8, 12, and 24
Erythrocyte Sedimentation Rate (ESR) (mm/h)
Time Frame: Weeks 1, 4, 8, 12, and 24
Evaluated via peripheral blood samples to explore the systemic anti-inflammatory effect of CG-BM1.
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
Measured via enzyme-linked immunosorbent assay (ELISA) from collected serum samples to investigate the mechanistic pathways of bone remodeling and immune regulation.
Weeks 1, 4, 8, 12, and 24
Peripheral Blood Immune Cell Subset Percentages
Time Frame: Weeks 1, 4, 8, 12, and 24
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.
Weeks 1, 4, 8, 12, and 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Eighth Affiliated Hospital, Sun Yat-sen University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Guangzhou Cellgenes Biotechnology Co.,Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 26, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 2, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 8, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 8, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 2, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MR-44-26-023756

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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