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

Primary Purpose

Rheumatoid Arthritis

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
UC-MSCs
Sponsored by
Xijing Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring anemia, Interstitial pulmonary disease

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Xijing HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

UC-MSCs treatment

no UC-MSCs treatment

Arm Description

the participants will receive the single-dose UC-MSCs (1×10^6 cells/kg ) in combined with the present treatment.

the participants will receive the placebo in combined with the present treatment.

Outcomes

Primary Outcome Measures

Improvement rate of blood routine hemoglobin (HGB) compared to baseline.
The HGB increases by 10g compared to the baseline is considered improvement.
Improvement rate of forced vital capacity (FVC) and/or carbon monoxide diffusing capacity (DLCO) compared to baseline.
FVC increases by 0.5% and DLCO increases by 10% compared to baseline are considered improvement.

Secondary Outcome Measures

The remission rates of American College of Rheumatology (ACR) 20, ACR 50 and ACR 70.
The patients achieves 20%, 50%, or 70% remission according to American College of Rheumatology (ACR) criteria.
White blood cell count and platelet count improved compared to the baseline.
White blood cell count increases to the 3.5×10^9/L and platelet count increases to 80×10^ 9.
Improvement rate of blood routine hemoglobin (HGB) compared to baseline.
The HGB increases by 10 g compared to the baseline is considered improvement.
Improvement rate of forced vital capacity (FVC) and/or carbon monoxide
FVC increases by 0.5% and DLCO increases by 10% compared to baseline
Image improvement of lung on high resolution CT.
The area change of image of lung.
Improvement of 6-minute walking distance compared to baseline.

Full Information

First Posted
January 7, 2019
Last Updated
January 7, 2019
Sponsor
Xijing Hospital
Collaborators
Changhai Hospital, Southwest Hospital, China
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1. Study Identification

Unique Protocol Identification Number
NCT03798028
Brief Title
The Safety and Effects of Mesenchymal Stem Cell (MSCs) in the Treatment of Rheumatoid Arthritis
Official Title
The Effects and Safety of Mesenchymal Stem Cells in the Treatment of Moderate/Severe Rheumatoid Arthritis， a Multicenter Randomized Controlled Clinical Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Unknown status
Study Start Date
December 26, 2017 (Actual)
Primary Completion Date
December 31, 2019 (Anticipated)
Study Completion Date
June 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xijing Hospital
Collaborators
Changhai Hospital, Southwest Hospital, China

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
anemia, Interstitial pulmonary disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
UC-MSCs treatment
Arm Type
Experimental
Arm Description
the participants will receive the single-dose UC-MSCs (1×10^6 cells/kg ) in combined with the present treatment.
Arm Title
no UC-MSCs treatment
Arm Type
No Intervention
Arm Description
the participants will receive the placebo in combined with the present treatment.
Intervention Type
Biological
Intervention Name(s)
UC-MSCs
Other Intervention Name(s)
placebo
Intervention Description
The UC-MSCs will be administrated by intravenous injection at the dose of 1×10^6 cells/kg.
Primary Outcome Measure Information:
Title
Improvement rate of blood routine hemoglobin (HGB) compared to baseline.
Description
The HGB increases by 10g compared to the baseline is considered improvement.
Time Frame
24 weeks
Title
Improvement rate of forced vital capacity (FVC) and/or carbon monoxide diffusing capacity (DLCO) compared to baseline.
Description
FVC increases by 0.5% and DLCO increases by 10% compared to baseline are considered improvement.
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
The remission rates of American College of Rheumatology (ACR) 20, ACR 50 and ACR 70.
Description
The patients achieves 20%, 50%, or 70% remission according to American College of Rheumatology (ACR) criteria.
Time Frame
12 weeks and 24 weeks
Title
White blood cell count and platelet count improved compared to the baseline.
Description
White blood cell count increases to the 3.5×10^9/L and platelet count increases to 80×10^ 9.
Time Frame
12 weeks and 24 weeks
Title
Improvement rate of blood routine hemoglobin (HGB) compared to baseline.
Description
The HGB increases by 10 g compared to the baseline is considered improvement.
Time Frame
12 weeks
Title
Improvement rate of forced vital capacity (FVC) and/or carbon monoxide
Description
FVC increases by 0.5% and DLCO increases by 10% compared to baseline
Time Frame
12 weeks
Title
Image improvement of lung on high resolution CT.
Description
The area change of image of lung.
Time Frame
24 weeks
Title
Improvement of 6-minute walking distance compared to baseline.
Time Frame
12 weeks and 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Fulfill 2010 ACR/ the European League Against Rheumatism (EULAR) classification criteria or the 1987 ACR classification criteria. Age limits:18 to 70 years old. Freely given informed consent. Disease Activity Score (DAS) 28≥3.2或 Simple Disease Activity Index (SDAI)>11.0或 Clinical Disease Activity Index (CDAI) >10.0. Hemoglobin < 90 g/L and/or interstitial lung disease shown in high resolution CT. 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. 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: Participants who received glucocorticoid therapy by intra-articular injection within 1 week. Glucocorticoid that participants received is more than 10 mg/day of prednisone within 1 months. Complication with other connective tissue disease (except for Sjogren syndrome) . Participants with chronic and acute infection (bacteria, virus and parasite,etc.). Participants with acute and chronic tuberculosis infection. Malignant tumors or participants with a family history of malignant tumors. Participants have a family history of allergic conditions. Participants infected by Hepatitis B Virus(HBV), Hepatitis C Virus (HCV) and Human Immunodeficiency Virus （HIV）. Participants suffer from central nervous system demyelinating disease or multiple sclerosis (MS) currently or in the past. Participants received live vaccines with 3 months. Drug abuse and alcoholism. Participants with severe mental or neurological disorders that affect informed consent and/or the presentation or observer of adverse events. Participants with pregnant or in breast-feeding, and patients who has a pregnancy plan within 1 year. Participants received stem cell therapy in the past. Participants received any biological agents within 3 months. Anemia (such as anemia with dysplasia) and interstitial lung disease for other reasons. Participants with cardiovascular and cerebrovascular damage, such as thrombosis. Participants taking drugs that affect the test for blood and lung. Participants taking any traditional Chinese medicine. Participants taking immune modulators such as Transfer Factor, Thymosin and Intravenous Immunoglobulin (IVIG), and so on. Other cases that participants are considered by investigator that they did not meet the requirements for enrollment.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ping Zhu, Doctor
Phone
86-29-84773951
Email
zhuping@fmmu.edu.cn
Facility Information:
Facility Name
Xijing Hospital
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ping Zhu
Phone
862984773951
Ext
862984773951
Email
zhuping@fmmu.edu.cn

12. IPD Sharing Statement

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

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