The Safety and Effects of Mesenchymal Stem Cell (MSCs) in the Treatment of Rheumatoid Arthritis

January 7, 2019 updated by: Xijing Hospital

The Effects and Safety of Mesenchymal Stem Cells in the Treatment of Moderate/Severe Rheumatoid Arthritis， a Multicenter Randomized Controlled Clinical Study

This study evaluates the safety and therapeutic effects of single-dose human umbilical cord blood mesenchymal stem cells (UC-MSCs) on the adult patients with moderate/severe Rheumatoid Arthritis accompany with anemia or/and Interstitial pulmonary disease. Half of participants will receive UC-MSCs and keep the present medication,while the other half will receive a placebo and keep the present medication.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
250

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710032
        • Recruiting
        • Xijing Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Fulfill 2010 ACR/ the European League Against Rheumatism (EULAR) classification criteria or the 1987 ACR classification criteria.
  2. Age limits:18 to 70 years old.
  3. Freely given informed consent.
  4. Disease Activity Score (DAS) 28≥3.2或 Simple Disease Activity Index (SDAI)>11.0或 Clinical Disease Activity Index (CDAI) >10.0.
  5. Hemoglobin < 90 g/L and/or interstitial lung disease shown in high resolution CT.
  6. Poor response to current treatment. The current treatment refers to receive the medicines (including Leflunomide, Methotrexate, Sulphasalazine, Hydroxychloroquine, Cyclosporine A,and Tacrolimus, alone or in combination ) for 3 months, and maintain the stable-dose of drugs for at least 1 month.
  7. More than 3 months and a stable dose for at least 1 month are required if glucocorticoid is used. The dose of glucocorticoid is less than or equal to10mg/ day of prednisone.

Exclusion Criteria:

  1. Participants who received glucocorticoid therapy by intra-articular injection within 1 week.
  2. Glucocorticoid that participants received is more than 10 mg/day of prednisone within 1 months.
  3. Complication with other connective tissue disease (except for Sjogren syndrome) .
  4. Participants with chronic and acute infection (bacteria, virus and parasite,etc.).
  5. Participants with acute and chronic tuberculosis infection.
  6. Malignant tumors or participants with a family history of malignant tumors.
  7. Participants have a family history of allergic conditions.
  8. Participants infected by Hepatitis B Virus(HBV), Hepatitis C Virus (HCV) and Human Immunodeficiency Virus （HIV）.
  9. Participants suffer from central nervous system demyelinating disease or multiple sclerosis (MS) currently or in the past.
  10. Participants received live vaccines with 3 months.
  11. Drug abuse and alcoholism.
  12. Participants with severe mental or neurological disorders that affect informed consent and/or the presentation or observer of adverse events.
  13. Participants with pregnant or in breast-feeding, and patients who has a pregnancy plan within 1 year.
  14. Participants received stem cell therapy in the past.
  15. Participants received any biological agents within 3 months.
  16. Anemia (such as anemia with dysplasia) and interstitial lung disease for other reasons.
  17. Participants with cardiovascular and cerebrovascular damage, such as thrombosis.
  18. Participants taking drugs that affect the test for blood and lung.
  19. Participants taking any traditional Chinese medicine.
  20. Participants taking immune modulators such as Transfer Factor, Thymosin and Intravenous Immunoglobulin (IVIG), and so on.
  21. Other cases that participants are considered by investigator that they did not meet the requirements for enrollment.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: UC-MSCs treatment
the participants will receive the single-dose UC-MSCs (1×10^6 cells/kg ) in combined with the present treatment.
Biological: UC-MSCs
The UC-MSCs will be administrated by intravenous injection at the dose of 1×10^6 cells/kg.
Other Names:
  • placebo
No Intervention: no UC-MSCs treatment
the participants will receive the placebo in combined with the present treatment.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Improvement rate of blood routine hemoglobin (HGB) compared to baseline.
Time Frame: 24 weeks
The HGB increases by 10g compared to the baseline is considered improvement.
24 weeks
Improvement rate of forced vital capacity (FVC) and/or carbon monoxide diffusing capacity (DLCO) compared to baseline.
Time Frame: 24 weeks
FVC increases by 0.5% and DLCO increases by 10% compared to baseline are considered improvement.
24 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The remission rates of American College of Rheumatology (ACR) 20, ACR 50 and ACR 70.
Time Frame: 12 weeks and 24 weeks
The patients achieves 20%, 50%, or 70% remission according to American College of Rheumatology (ACR) criteria.
12 weeks and 24 weeks
White blood cell count and platelet count improved compared to the baseline.
Time Frame: 12 weeks and 24 weeks
White blood cell count increases to the 3.5×10^9/L and platelet count increases to 80×10^ 9.
12 weeks and 24 weeks
Improvement rate of blood routine hemoglobin (HGB) compared to baseline.
Time Frame: 12 weeks
The HGB increases by 10 g compared to the baseline is considered improvement.
12 weeks
Improvement rate of forced vital capacity (FVC) and/or carbon monoxide
Time Frame: 12 weeks
FVC increases by 0.5% and DLCO increases by 10% compared to baseline
12 weeks
Image improvement of lung on high resolution CT.
Time Frame: 24 weeks
The area change of image of lung.
24 weeks
Improvement of 6-minute walking distance compared to baseline.
Time Frame: 12 weeks and 24 weeks
12 weeks and 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Xijing Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Changhai Hospital
Southwest Hospital, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 26, 2017

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2019

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 7, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 7, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 9, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 9, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 7, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2014ZX09508002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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