Human Umbilical Cord-Mesenchymal Stem Cells for Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02643823
• Other study ID #: HYK-Rheumatoid Arthritis
• Status: Recruiting
• Phase: Phase 1
• First received: December 23, 2015
• Last updated: May 23, 2016
• Start date: January 2016
• Est. completion date: June 2017

Study information

• Verified date: December 2015
• Source: Shenzhen Hornetcorn Bio-technology Company, LTD
• Contact: Wei J Zhong
• Phone: +86 0755-83980805
• Email: ZhongJW[@]163.com
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: June 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

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.

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

Locations

Country	Name	City	State
China	The Fourth People's Hospital of Shenzhen	Shenzhen	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
Shenzhen Hornetcorn Bio-technology Company, LTD	Futian People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Severity of adverse events	According to National Cancer Institute Common Terminology Criteria for Adverse Events(NCI-CTCAE)	12 months	Yes
Secondary	RA Serology	Rheumatoid Factor, C-reactive protein	1, 3 ,6 and 12 months	No
Secondary	Disease Activity Score (DAS 28) Index		1, 3, 6 and 12 months	No