Autologous Adipose-derived Stem Cells (AdMSCs) for Rheumatoid Arthritis

This is an interventional treatment trial for Rheumatoid Arthritis Read More

Inclusion Criteria:

• Must pass communicable disease screen tests for HIV, syphilis, Hepatitis B and C Consistent with American Rheumatism Association-European League Against Rheumatism (ACR/EULAR) 2010 rheumatoid arthritis classification criteria
• Active Rheumatoid Arthritis, see RA functional status of class I-IV
• Patients must meet at least one of the following: > 6 swollen joints and ≥ 6 involved joints (tenderness, swelling, deformity, pain on motion, or decreased motion) and morning stiffness ≥ 45 minutes based on 68 joint count.
• Patients must also meet at least one of the following: rheumatoid factor (RF) > 15 IU/mL or > 1:16, C-reactive protein (CRP) > 2.0 mg/dL, Erythrocyte Sedimentation Rate (ESR) > 30 mm/hour, and anti-cyclic citrullinated protein (Anti-CCP) > 20 U/mL, TNFα > 2.8 pg/mL.
• Patients must have failed anti-rheumatoid drug due to adverse event or inefficacy for at least 12 week and at least 4 weeks on stable dose of methotrexate ≤ 25 mg/week, or leflunomide ≤ 20 mg/day, or sulfasalazine ≤ 3 g/day, or steroids (Prednisone <10 mg/day).
• For other medications, patients must be on the stable dose for at least 4 weeks prior to study entry in order to preclude changes to patient medication while participating on the study to ensure that a medication change could become a confounding factor in data interpretation.
• All patients must be clinically stable with no significant changes in health status a minimum of at least 4 weeks prior to randomization and confirming patient eligibility

Exclusion Criteria:

1. Current or prior to treatment

   • Participation in another clinical study (with use of another Investigational Medical Product) within 3 months prior to study treatment start
   • Evidence of immune suppression related to prior/current therapy
   • > 10% change in delivered monthly dose of anti-rheumatoid medications within 4 weeks prior to this stem cell infusion
   • Use of a new or additional anti-rheumatoid medication within 6 weeks prior to this stem cell infusion
   • Use of other stem cell therapy within 12 weeks prior to this stem cell therapy
   • Unwillingness or inability to comply with study procedures

2. Concurrent Conditions

   • Clinically active malignant disease
   • Severe bladder or thrombotic disorder
   • History of known pulmonary embolism or known secondary anti-phospholipid syndrome
   • Known or suspected hypersensitivity to any components used to culture or store the AdMSCs, e.g. sulfur or sulfonamide
   • Known or suspected antibodies to any components used to culture the AdMSCs, e.g. BSA and sulfur containing products (e.g., DMSO)
   • Active infection at time of planned study treatment start
   • Age related pathology likely to inhibit study participation or completion
   • Major trauma or surgery within 14 days of study treatment start
   • Mental condition rendering the subject (or the subject's legally acceptable representative[s]) unable to understand the nature, scope and possible consequences of the study
   • Alcohol, drug, or medication abuse within one year before study treatment start
   • Any condition that, in the Investigator's opinion, is likely to interfere with evaluation of the AdMSC therapy or satisfactory conduct of the study
   • Irreversible severe end organ failure, such as heart failure/attack, stroke, liver and renal failure
   • Heavy smokers, bed-bound patients, patients or family history with hypercoagulable status, such as protein C/protein S deficiency, factor V Leiden, prothrombin gene mutation, dysfibrinogenemia, etc.

3. Laboratory Parameters

   • Hepatic impairment, defined as any of ALT, AST, LDH or bilirubin > 2 x the upper limit of normal (ULN) range according to local laboratory standards
   • Renal impairment, defined as serum creatinine > 133 mmol/L (1.5 mg/dL)
   • Positive virology/serology for human immunodeficiency virus (HIV), hepatitis B (HBsAg positive), hepatitis C and/or syphilis

4. Pregnancy / contraception

   • Pregnant, breastfeeding, or desire to become pregnant or unwilling to practice birth control during participation in the study duration, unless surgically sterilized or postmenopausal during the study