This is a Phase I-II open- label single-dose study in subjects with significant refractory Rheumatoid Arthritis (RA), relapsing Systemic Lupus Erythematosus (SLE) or Sharp's Syndrome (SS). This study will enroll a minimum of 20 subjects for RA, 20 subjects for SLE and 20 patients for SS. 6 week data of serum Tumor Necrosis Factor- alpha (TNFa), Interleukin- 6 (IL-6), C- Reactive Protein (CRP), Erythrocyte Sedimentation Rate (ESR), Cluster of Differentiation (CD)4 +CD25 + Forkhead box P3(Foxp3) + regulatory T cells, Disease Activity Score for 28 joints (DAS-28) score and pain score will be collected in all patients who are enrolled in the study for the RA group (Baseline and 6 weeks after). For the SLE group, Transforming Growth Factor- beta (TGF-β), TNFa, IL-6, Interleukin- 17 (IL-17), CD3+CD8-IL17A+ T helper-17 (Th17) cells, CD4+CD25+Foxp3+ regulatory T cells and the Systemic Lupus Erythematosus Quality of Life Questionnaire (SLEQoL) score will be collected in all the subjects of this group. SS group will undergo the assessments of RA and SLE. Prior to the stem cell treatment, the patient will be assessed for 6 weeks by all the previously mentioned markers. Then, patients will receive the infusion of stromal vascular fraction cells containing the adult adipose derived stem cells 'aADSC' (single intravenous dose). The disease- modifying anti-rheumatic drugs (DMARDs) or the standard SLE treatment will not be interrupted with the exception of systemic steroids (excluding minimal maintenance dose of one steroid) during the duration of the study. Follow up visits will take place at 6 weeks, 3 Months and 6 Months after the cell infusion. Safety will be monitored on an ongoing basis, and an interim safety review will be conducted by the Investigator(s) and Sponsor after the first 10 patients have been enrolled and treated in each group.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
2
Arkansas Heart Hospital
Little Rock, Arkansas, United States
Frequency of Adverse Events (AE) and Serious Adverse Events (SAE) during a 6 month follow up period.
Time frame: 6 Months
Quality of Life Questionnaires for SLE/ RA
SLEQoL score
Time frame: 6 Months
Quality of Life Questionnaires for RA
DAS-28 score
Time frame: 6 Months
Blood Flow Cytometry for CD4+CD25+Foxp3+ regulatory T cells
CD4+CD25+Foxp3+ regulatory T cells,
Time frame: 6 Months
Blood Flow Cytometry for CD3+CD8-IL17A+TH17 cells
CD3+CD8-IL17A+TH17 cells
Time frame: 6 Months
Serum C- reactive protein (CRP)
C- reactive protein (CRP)
Time frame: 6 Months
Erythrocyte Sedimentation Rate (ESR)
Erythrocyte Sedimentation Rate (ESR)
Time frame: 6 Months
Serum Tumor Necrosis Factor- alpha (TNFa)
Tumor Necrosis Factor- alpha (TNFa)
Time frame: 6 Months
Serum Transforming Growth Factor- beta (TGFb)
Transforming Growth Factor- beta (TGFb)
Time frame: 6 Months
Serum Interleukin- 6 (IL-6)
Interleukin- 6 (IL-6)
Time frame: 6 Months
Serum Interleukin- 17 (IL-17)
Interleukin- 17 (IL-17)
Time frame: 6 Months
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