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Safety and Tolerance of Umbilical Cord Mesenchymal Stem Cells (UC-MSC) in Patients With Ankylosing Spondylitis

NCT05962762 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2023-08-15

No results posted yet for this study

Summary

The goal of this clinical trial is to evaluate the safety and tolerability of multiple doses of human umbilical cord mesenchymal stem cell injection in patients with Ankylosing Spondylitis, and to further explore the efficacy, pharmacodynamic profile and appropriate dose of administration to provide a basis for the use of safer and more effective treatments for patients with Ankylosing Spondylitis in the future.

Participants are required to sign an informed consent form and, after undergoing a series of tests and meeting the protocol's entry and exclusion criteria, are assigned to a dose group for intravenous infusion of human umbilical cord mesenchymal stem cells.

Conditions

Interventions

BIOLOGICAL

Human Umbilical Cord Mesenchymal Stem Cells

The trial was conducted sequentially from the low dose group to the high dose group, with 3-6 subjects enrolled in each dose group. The trial was conducted on a case-by-case basis in the high dose group, with each subject in the high dose group being enrolled in subsequent subjects only after completion of at least 7 days of post-dose safety observation. Each subject received only one corresponding dose. All subjects received experimental drugs and conventional treatment during the study period. All subjects in each test dose group will complete a 4-week (28-day) dose-limiting toxicity (DLT) After the observational evaluation period, a decision will be made by the investigator and sponsor based on a discussion of relevant safety data whether to start the next dose group.

Sponsors & Collaborators

  • RenJi Hospital

    collaborator OTHER

  • Asia Cell Therapeutics (Shanghai) Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Chunde Bao · RenJi Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2023-08-30
Primary Completion
2026-12-31
Completion
2027-12-31

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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 NCT05962762 on ClinicalTrials.gov