Human Umbilical Cord-Mesenchymal Stem Cells for Rheumatoid Arthritis

Shenzhen Hornetcorn Biotechnology

Status and phase: Unknown; Phase 1

Conditions: Rheumatoid Arthritis

Treatments: Drug: DMARDs; Biological: hUC-MSC + DMARDs

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02643823

HYK-Rheumatoid Arthritis

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

hUC-MSC + DMARDs

Experimental group

Description:

Patients will be treated in combination with hUC-MSC and DMARDs with a 12 months follow-up.

Treatment:

Biological: hUC-MSC + DMARDs

DMARDs

Active Comparator group

Description:

Patients will be treated by Rheumatoid Arthritis With Disease-Modifying Drugs (DMARDs) with a 12 months follow-up.

Treatment:

Drug: DMARDs