The Safety and Effects of Mesenchymal Stem Cell (MSCs) in the Treatment of Rheumatoid Arthritis
The Effects and Safety of Mesenchymal Stem Cells in the Treatment of Moderate/Severe Rheumatoid Arthritis， a Multicenter Randomized Controlled Clinical Study
1 other identifier
interventional
250
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable rheumatoid-arthritis
Started Dec 2017
Typical duration for not_applicable rheumatoid-arthritis
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 26, 2017
CompletedFirst Submitted
Initial submission to the registry
January 7, 2019
CompletedFirst Posted
Study publicly available on registry
January 9, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2020
CompletedJanuary 9, 2019
December 1, 2018
2 years
January 7, 2019
January 7, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Improvement rate of blood routine hemoglobin (HGB) compared to baseline.
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.
FVC increases by 0.5% and DLCO increases by 10% compared to baseline are considered improvement.
24 weeks
Secondary Outcomes (6)
The remission rates of American College of Rheumatology (ACR) 20, ACR 50 and ACR 70.
12 weeks and 24 weeks
White blood cell count and platelet count improved compared to the baseline.
12 weeks and 24 weeks
Improvement rate of blood routine hemoglobin (HGB) compared to baseline.
12 weeks
Improvement rate of forced vital capacity (FVC) and/or carbon monoxide
12 weeks
Image improvement of lung on high resolution CT.
24 weeks
- +1 more secondary outcomes
Study Arms (2)
UC-MSCs treatment
EXPERIMENTALthe participants will receive the single-dose UC-MSCs (1×10\^6 cells/kg ) in combined with the present treatment.
no UC-MSCs treatment
NO INTERVENTIONthe participants will receive the placebo in combined with the present treatment.
Interventions
The UC-MSCs will be administrated by intravenous injection at the dose of 1×10\^6 cells/kg.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Xijing Hospitallead
- Changhai Hospitalcollaborator
- Southwest Hospital, Chinacollaborator
Study Sites (1)
Xijing Hospital
Xi'an, Shaanxi, 710032, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 7, 2019
First Posted
January 9, 2019
Study Start
December 26, 2017
Primary Completion
December 31, 2019
Study Completion
June 30, 2020
Last Updated
January 9, 2019
Record last verified: 2018-12