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

Not Applicable

• Conditions: Rheumatoid Arthritis
• Interventions: Biological: UC-MSCs

• Registration Number: NCT03798028
• Lead Sponsor: Xijing Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-12-26
• Status Verified: 2018-12
• Study First Submitted: 2019-01-07
• Study First Submitted QC: 2019-01-07
• Last Update Submitted: 2019-01-07
• Study First Posted: 2019-01-09
• Last Update Posted: 2019-01-09
• Primary Completion: 2019-12-31
• Study Completion: 2020-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 250

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Improvement rate of blood routine hemoglobin (HGB) compared to baseline.	24 weeks	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.	24 weeks	FVC increases by 0.5% and DLCO increases by 10% compared to baseline are considered improvement.

Secondary Outcome Measures

Name	Time	Method
Improvement rate of blood routine hemoglobin (HGB) compared to baseline.	12 weeks	The HGB increases by 10 g compared to the baseline is considered improvement.
Improvement rate of forced vital capacity (FVC) and/or carbon monoxide	12 weeks	FVC increases by 0.5% and DLCO increases by 10% compared to baseline
Improvement of 6-minute walking distance compared to baseline.	12 weeks and 24 weeks
White blood cell count and platelet count improved compared to the baseline.	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.
The remission rates of American College of Rheumatology (ACR) 20, ACR 50 and ACR 70.	12 weeks and 24 weeks	The patients achieves 20%, 50%, or 70% remission according to American College of Rheumatology (ACR) criteria.
Image improvement of lung on high resolution CT.	24 weeks	The area change of image of lung.

Trial Locations

Locations (1)

Xijing Hospital; 🇨🇳 Xi'an, Shaanxi, China