Human Umbilical Cord-Mesenchymal Stem Cells for Rheumatoid Arthritis

Phase 1

• Conditions: Rheumatoid Arthritis
• Interventions: Biological: hUC-MSC + DMARDs; Drug: DMARDs

• Registration Number: NCT02643823
• Lead Sponsor: Shenzhen Hornetcorn Bio-technology Company, LTD

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of human umbilical cord mesenchymal stem cell(hUC-MSC) for Rheumatoid Arthritis.

Detailed Description

Human umbilical cord mesenchymal stem cells exhibit the potential to differentiate into chondrocyte and osteocyte, which have been confirmed in in vivo and in vitro experiments. There have been few clinical reports describing umbilical cord mesenchymal stem cells for treatment of Rheumatoid Arthritis.

To investigate the effects of hUC-MSC treatment for Rheumatoid Arthritis, 20 patients with Rheumatoid Arthritis will be enrolled and receive 4 times of hUC-MSC transplantation.

Study Timeline

• Status Verified: 2015-12
• Study First Submitted: 2015-12-23
• Study First Submitted QC: 2015-12-28
• Study First Posted: 2015-12-31
• Study Start: 2016-01
• Last Update Submitted: 2016-05-23
• Last Update Posted: 2016-05-24
• Primary Completion: 2017-01
• Study Completion: 2017-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Aged 18-80 Rheumatoid Arthritis patient;
• Patients must consent in writing to participate in the study by signing and dating an informed consent document;
• Patients must have a diagnosis of Rheumatoid Arthritis according to the 2010 ACR/EULAR criteria for at least 12 weeks duration;
• Stage I and II according to X-ray.

Exclusion Criteria

• History of neurological disease, head injury or psychiatric disorder;
• Pregnant women;
• Impaired liver function, abnormal blood coagulation, AIDS, HIV, combine other tumor or special condition;
• Progressive apoplexy;
• With malignant tumors;
• Patients who had participated in other clinical trials within three months prior to this study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
hUC-MSC + DMARDs	hUC-MSC + DMARDs	Patients will be treated in combination with hUC-MSC and DMARDs with a 12 months follow-up.
DMARDs	DMARDs	Patients will be treated by Rheumatoid Arthritis With Disease-Modifying Drugs (DMARDs) with a 12 months follow-up.

Primary Outcome Measures

Name	Time	Method
Severity of adverse events	12 months	According to National Cancer Institute Common Terminology Criteria for Adverse Events（NCI-CTCAE)

Secondary Outcome Measures

Name	Time	Method
Disease Activity Score (DAS 28) Index	1, 3, 6 and 12 months
RA Serology	1, 3 ,6 and 12 months	Rheumatoid Factor, C-reactive protein

Trial Locations

Locations (1)

The Fourth People's Hospital of Shenzhen; 🇨🇳 Shenzhen, Guangdong, China