Clinical Trial: Safety and Efficacy of Adipose Derived Stem Cells in Refractory Rheumatoid Arthritis, Systemic Lupus Erythematosus or Sharp's Syndrome

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: A Phase I-II Open- Label Study to Assess the Safety, Tolerability, and Preliminary Efficacy of a Single Intravenous Dose of Autologous Adipose Stem Cell (Adult Human) to Subjects With Refractory Rheum

Brief Summary:

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.


Detailed Summary:
Sponsor: Arkansas Heart Hospital

Current Primary Outcome: Frequency of Adverse Events (AE) and Serious Adverse Events (SAE) during a 6 month follow up period. [ Time Frame: 6 Months ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Quality of Life Questionnaires for SLE/ RA [ Time Frame: 6 Months ]
    SLEQoL score
  • Quality of Life Questionnaires for RA [ Time Frame: 6 Months ]
    DAS-28 score
  • Blood Flow Cytometry for CD4+CD25+Foxp3+ regulatory T cells [ Time Frame: 6 Months ]
    CD4+CD25+Foxp3+ regulatory T cells,
  • Blood Flow Cytometry for CD3+CD8-IL17A+TH17 cells [ Time Frame: 6 Months ]
    CD3+CD8-IL17A+TH17 cells
  • Serum C- reactive protein (CRP) [ Time Frame: 6 Months ]
    C- reactive protein (CRP)
  • Erythrocyte Sedimentation Rate (ESR) [ Time Frame: 6 Months ]
    Erythrocyte Sedimentation Rate (ESR)
  • Serum Tumor Necrosis Factor- alpha (TNFa) [ Time Frame: 6 Months ]
    Tumor Necrosis Factor- alpha (TNFa)
  • Serum Transforming Growth Factor- beta (TGFb) [ Time Frame: 6 Months ]
    Transforming Growth Factor- beta (TGFb)
  • Serum Interleukin- 6 (IL-6) [ Time Frame: 6 Months ]
    Interleukin- 6 (IL-6)
  • Serum Interleukin- 17 (IL-17) [ Time Frame: 6 Months ]
    Interleukin- 17 (IL-17)


Original Secondary Outcome: Same as current

Information By: Arkansas Heart Hospital

Dates:
Date Received: April 6, 2016
Date Started: December 2015
Date Completion:
Last Updated: March 2, 2017
Last Verified: March 2017