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

PHASE1Not yet recruitingINTERVENTIONAL
Enrollment

9

Participants

Timeline

Start Date

August 30, 2023

Primary Completion Date

December 31, 2026

Study Completion Date

December 31, 2027

Conditions
Ankylosing Spondylitis
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."

All Listed Sponsors
collaborator

RenJi Hospital

OTHER

lead

Asia Cell Therapeutics (Shanghai) Co., Ltd.

INDUSTRY