Human Umbilical Cord-Mesenchymal Stem Cells for Rheumatoid Arthritis

Sponsor

Shenzhen Hornetcorn Bio-technology Company, LTD (Industry)

Overall Status

Unknown status

CT.gov ID

NCT02643823

Collaborator

Futian People's Hospital (Other)

Enrollment

Location

Arms

Duration (Months)

2.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Rheumatoid Arthritis	Biological: hUC-MSC + DMARDs Drug: DMARDs	Phase 1

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 Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Safety and Efficacy Study of Human Umbilical Cord-Mesenchymal Stem Cells for Rheumatoid Arthritis

Study Start Date :

Jan 1, 2016

Anticipated Primary Completion Date :

Jan 1, 2017

Anticipated Study Completion Date :

Jun 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: hUC-MSC + DMARDs Patients will be treated in combination with hUC-MSC and DMARDs with a 12 months follow-up.	Biological: hUC-MSC + DMARDs Patients will be treated by conventional drugs (DMARDs) for alleviating disease. Combinated with a single dose of 2×107 hUC-MSC will treated to patients, IV, Repeat every weeks for four times. Other Names: Human Umbilical Cord-Mesenchymal Stem Cells
Active Comparator: DMARDs Patients will be treated by Rheumatoid Arthritis With Disease-Modifying Drugs (DMARDs) with a 12 months follow-up.	Drug: DMARDs Patients will be treated by conventional drugs (DMARDs) for alleviating disease. Other Names: NSAIDs Methotrexate

Arm

Intervention/Treatment

Experimental: hUC-MSC + DMARDs

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

Biological: hUC-MSC + DMARDs

Patients will be treated by conventional drugs (DMARDs) for alleviating disease. Combinated with a single dose of 2×107 hUC-MSC will treated to patients, IV, Repeat every weeks for four times.

Other Names:

Human Umbilical Cord-Mesenchymal Stem Cells

Active Comparator: DMARDs

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

Drug: DMARDs

Patients will be treated by conventional drugs (DMARDs) for alleviating disease.

Other Names:

NSAIDs

Methotrexate

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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.