Safety and Efficacy of Allogeneic Bone Marrow MSCs in Ankylosing Spondylitis (NCT07632599) | Clinical Trial Compass
Not Yet RecruitingPhase 1
Safety and Efficacy of Allogeneic Bone Marrow MSCs in Ankylosing Spondylitis
China40 participantsStarted 2026-07-01
Plain-language 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.
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)
Who can participate
Age range
18 Years – 40 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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) with…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this is a Phase 1 trial focused mainly on measuring adverse events and dose-limiting toxicities rather than whether the treatment works, what does that mean for me in terms of what we'd actually learn about safety versus benefit if I were to participate?
2This trial uses allogeneic bone marrow MSCs — meaning cells from a donor rather than my own body — what risks does my doctor think come specifically with receiving someone else's cells for ankylosing spondylitis?
3The trial hasn't started recruiting yet, so how long might I realistically be waiting before it opens, and should I be considering other treatment options in the meantime rather than putting other plans on hold?
4Are there standard treatments for ankylosing spondylitis — like biologics or NSAIDs — that my doctor would recommend I try first before considering an early-phase experimental cell therapy like this one?
5Given that this is still Phase 1, what is my doctor's honest assessment of whether the potential benefit of joining a very early safety study outweighs continuing with or switching my current treatment approach?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs)
Timeframe: 24 weeks
2
Incidence of Dose-Limiting Toxicities (DLTs)
Timeframe: 24 weeks
Trial details
NCT IDNCT07632599
SponsorEighth Affiliated Hospital, Sun Yat-sen University