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ACTIVE NOT RECRUITING
NCT04971980
PHASE1/PHASE2

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

Sponsor: Beijing Baylx Biotech Co., Ltd.

View on ClinicalTrials.gov

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.

Official title: A Phase 1/2a, Open-Label Study to Evaluate the Safety and Efficacy of a Single Intravenous Infusion of BC-U001, a Human Umbilical Cord-Derived Mesenchymal Stem Cell Product, for Rheumatoid Arthritis

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

9

Start Date

2021-04-12

Completion Date

2025-11

Last Updated

2025-09-19

Healthy Volunteers

No

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.

Locations (1)

Peking Union Medical College Hospital (Dongdan campus)

Beijing, Beijing Municipality, China