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Human Umbilical Cord-Mesenchymal Stem Cells for Rheumatoid Arthritis

Primary Purpose

Rheumatoid Arthritis

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
hUC-MSC + DMARDs
DMARDs
Sponsored by
Shenzhen Hornetcorn Bio-technology Company, LTD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Human Umbilical Cord Mesenchymal Stem Cell, Mesenchymal Stem Cell, Rheumatoid Arthritis

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • The Fourth People's Hospital of ShenzhenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

hUC-MSC + DMARDs

DMARDs

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

RA Serology
Rheumatoid Factor, C-reactive protein
Disease Activity Score (DAS 28) Index

Full Information

First Posted
December 23, 2015
Last Updated
May 23, 2016
Sponsor
Shenzhen Hornetcorn Bio-technology Company, LTD
Collaborators
Futian People's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02643823
Brief Title
Human Umbilical Cord-Mesenchymal Stem Cells for Rheumatoid Arthritis
Official Title
Safety and Efficacy Study of Human Umbilical Cord-Mesenchymal Stem Cells for Rheumatoid Arthritis
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Unknown status
Study Start Date
January 2016 (undefined)
Primary Completion Date
January 2017 (Anticipated)
Study Completion Date
June 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shenzhen Hornetcorn Bio-technology Company, LTD
Collaborators
Futian People's Hospital

4. Oversight

Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
Human Umbilical Cord Mesenchymal Stem Cell, Mesenchymal Stem Cell, Rheumatoid Arthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
hUC-MSC + DMARDs
Arm Type
Experimental
Arm Description
Patients will be treated in combination with hUC-MSC and DMARDs with a 12 months follow-up.
Arm Title
DMARDs
Arm Type
Active Comparator
Arm Description
Patients will be treated by Rheumatoid Arthritis With Disease-Modifying Drugs (DMARDs) with a 12 months follow-up.
Intervention Type
Biological
Intervention Name(s)
hUC-MSC + DMARDs
Other Intervention Name(s)
Human Umbilical Cord-Mesenchymal Stem Cells
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
DMARDs
Other Intervention Name(s)
NSAIDs, Methotrexate
Intervention Description
Patients will be treated by conventional drugs (DMARDs) for alleviating disease.
Primary Outcome Measure Information:
Title
Severity of adverse events
Description
According to National Cancer Institute Common Terminology Criteria for Adverse Events（NCI-CTCAE)
Time Frame
12 months
Secondary Outcome Measure Information:
Title
RA Serology
Description
Rheumatoid Factor, C-reactive protein
Time Frame
1, 3 ,6 and 12 months
Title
Disease Activity Score (DAS 28) Index
Time Frame
1, 3, 6 and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wei J Zhong
Phone
+86 0755-83980805
Email
ZhongJW@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhong Z Ye, Professor
Organizational Affiliation
Futian People's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Fourth People's Hospital of Shenzhen
City
Shenzhen
State/Province
Guangdong
ZIP/Postal Code
518000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hao J, Professor
Phone
0755-83981333
Email
HaoJ@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Human Umbilical Cord-Mesenchymal Stem Cells for Rheumatoid Arthritis

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