Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Arkansas Heart Hospital
Age
18–99
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
1. Males and Females ≥18 years
2. Cognitive competitiveness.
3. Diagnosis of refractory RA (patient's poor response of 3 months of DMARDs determined and documented by a rheumatologist) ,diagnosis of relapsing SLE (more than 2 episodes in a year during optimal medical SLE therapy) or diagnosis of Sharp syndrome (Alarcon-Segovia's criteria: patients with U1 Ribonucleic protein (RNP) ≥ 1:1600, and three of the following: Swollen hands, Synovitis, Myositis, Raynauld's phenomenon, Acrosclerosis)
4. Life expectancy greater than 8 months
5. Ability to understand and provide signed informed consent, or have a designated legal guardian or spouse legally able and willing to make such decisions on the subject's behalf
6. Reasonable expectation that patient will receive standard post-treatment care and attend all scheduled safety follow-up visits
7. No changes in active pulmonary medications for heart failure during the two weeks prior enrollment.
8. Written informed consent
You may not be if
1. Currently on systemic steroids (if chronic steroid therapy cannot be stopped, the patient will qualify if he/she is on a minimum maintenance dose per SLE, RA or SS guidelines of only one systemic steroid and constituting a bioequivalent to normal endogenous levels of that hormone).
2. Dementia.
3. Presence of immune deficiency.
4. Currently on NSAIDs, TNFa inhibitors, Calcium channel blockers or P2Y12 inhibitors
5. Complicated type 2 diabetes mellitus (presence of diabetic foot, advanced kidney disease or retinopathy).
6. History of cancer within the past 5 years.
7. Presence of any other clinically-significant medical condition, psychiatric condition, or laboratory abnormality, that in the judgment of the Investigator or Sponsor for which participation in the study would pose a safety risk to the subject
8. Participation in another study with an investigational drug or device within 3 weeks prior to treatment
9. History within the past year of drug or alcohol abuse.
10. Females known to be pregnant, lactating or having a positive pregnancy test (will be tested during screening) or planning to become pregnant during the study.
11. Inability to comply with the conditions of the protocol.
12. Porphyria.
13. Allergy to sodium citrate or any "caine" type of local anesthetic.
