Umbilical Cord Tissue-derived Mesenchymal Stem Cells for Rheumatoid Arthritis

This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring rheumatoid arthritis, umbilical cord, mesenchymal, stem cells Read More

Inclusion Criteria:

• Signed inform consent by the subject.
• Age older than 18 years and ability to understand the planned treatment.
• Patients of either gender with RA with a duration of 6 months to 20 years defined as the presence of at least three of the following criteria: 3 or more painful, 2 or more swollen joints, morning stiffness for at least 45 minutes (on average during the week prior to entry), and an erythrocyte sedimentation rate (ESR) of at least 28 mm.
• Non-responsive to at least one course of one DMARD selected from the group comprising of: gold salts, leflunomide, methotrexate, and hydroxychloroquine.
• Second-line agents are discontinued at least 4 weeks prior to entry.
• Able to tolerate ALL study procedures
• Able to give informed Consent
• Negative for HcG with a serum pregnancy test
• Hematocrit ≥ 28.0%, White Blood Cell count ≤ 14,000, Platelet count ≥ 50,000,
• Life expectancy of 6 months or more in the opinion of the investigator
• Serum bilirubin, ALT, AST up to 2.5 time the upper level of normal.
• Controlled blood pressure (systolic blood pressure ≤140 and a diastolic blood pressure of ≤90 mmHG) and established anti-hypertensive therapy as necessary prior to entry into the study
• Patient has received stable, standard medical therapy for at least one month with no new medications to treat the disease introduced in the last month.
• Pre-existing condition (e.g. thromboembolic risk, diabetes, hypercholesterolemia) are adequately controlled in the opinion of the investigator
• Fertile patients (male and female) must agree to use an appropriate form of contraception while participating in the study.

Exclusion Criteria:

• Female who is pregnant or nursing, or of child-bearing potential and is not using a reliable birth control method, or who intend to become pregnant during the tenure of this study.
• History of prior radiation exposure for oncological treatment.
• History of Bone Marrow Disorder (especially NHL, MDS)
• History of abnormal bleeding or clotting.
• History of Liver Cirrhosis.
• End stage renal disease (Creatinine ≤ 3.0 mg / dl) and/or dialysis
• Active clinical infection being treated by antibiotics before one week enrollment
• Inability or unwillingness to comply with the treatment protocol, follow-up, research tests, or give consent.
• History of life-threatening arrhythmias, except if an automated implantable cardioverter defibrillator (AICD) is implanted
• Life expectancy <6 months due to concomitant illnesses
• Known cancer and undergoing treatment; chemotherapy and/or radiotherapy
• Patients receiving treatment with hematopoietic growth factors (e.g., EPO, G-CSF)
• Patients who can not stop anticoagulation therapy (warfarin) 72hrs prior to infusion
• Patients who can not stop anti-platelet therapy (clopidogrel) 7 days prior infusion
• Prior admission for substance abuse
• Body Mass Index (BMI) of 40 kg/m2 or greater
• Patient receiving experimental medication or participating in another clinical study within 30 days of signing the informed consent
• In the opinion of the investigator or the sponsor, the patient is unsuitable for cellular therapy