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Safety and Efficacy of Allogeneic Bone Marrow MSCs in Ankylosing Spondylitis

NCT07632599 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2026-06-08

No results posted yet for this study

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)

Conditions

Interventions

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

BIOLOGICAL

Placebo

Sodium Chloride Solution, 5 ml, IV, weekly × 4+ celecoxib, 0.2g, p.o. daily

BIOLOGICAL

CG-BM1

CG-BM1 \[recommended dose\], IV, weekly × 4 + celecoxib, 0.2g, p.o. daily

Sponsors & Collaborators

  • Guangzhou Cellgenes Biotechnology Co.,Ltd

    collaborator UNKNOWN

  • Eighth Affiliated Hospital, Sun Yat-sen University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-01
Primary Completion
2027-06-01
Completion
2027-06-01

Countries

  • China

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07632599 on ClinicalTrials.gov