Safety and Efficacy of Allogeneic Bone Marrow MSCs in Ankylosing Spondylitis

Sponsor
Eighth Affiliated Hospital, Sun Yat-sen University
Study ID
NCT07632599
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 40 Years
Healthy Volunteers
Not accepted

Interventions

  • IV administration of CG-BM1 — BIOLOGICAL
    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 — BIOLOGICAL
    Sodium Chloride Solution, 5 ml, IV, weekly × 4+ celecoxib, 0.2g, p.o. daily
  • CG-BM1 — BIOLOGICAL
    CG-BM1 \[recommended dose\], IV, weekly × 4 + celecoxib, 0.2g, p.o. daily

Study Details

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)

Key Dates

Start date
Jul 1, 2026
Status verified
May 2026
Primary completion
Jun 1, 2027
Completion
Jun 1, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • 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.
  • 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.
  • 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.

Primary Outcome Measure

Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: 24 weeks ]

Central Contacts

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