| Eligibility |
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, TNFa >
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
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