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Safety and Efficacy Study of Human Umbilical Cord-Derived Mesenchymal Stem Cells(BC-U001) for Rheumatoid Arthritis

NCT04971980 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2025-09-19

No results posted yet for this study

Summary

BC-U001 is an allogeneic fresh human umbilical cord-derived mesenchymal stem cell product, which showed therapeutic potential for rheumatoid arthritis(RA) based on its anti-inflammatory, immunomodulatory and tissue repair activities. The primary objective of this open-label, non-randomized, dose-escalation study is to evaluate the safety and tolerability of a single intravenous infusion of BC-U001 for RA patients using a 3+3 design.

Conditions

Interventions

DRUG

hUC-MSC infusion (BC-U001)

The participants are intravenously administered a single infusion of hUC-MSC at 0.5x10\^6 cells/kg body weight, 1.0x10\^6 cells/kg body weight, 1.5x10\^6 cells/kg body weight for low-dose cohort, medium-dose cohort and high-dose cohort respectively.

Sponsors & Collaborators

  • Beijing Baylx Biotech Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Xiaofeng Zeng, M.D., Ph.D. · Peking Union Medical College 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
2021-04-12
Primary Completion
2023-07-10
Completion
2025-11-30

Countries

  • China

Study Locations

More Related Trials

Entities

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 NCT04971980 on ClinicalTrials.gov