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NCT02741362 · ClinicalTrials.gov registry record · Phase 1
Safety and Efficacy of Adipose Derived Stem Cells in Refractory Rheumatoid Arthritis, Systemic Lupus Erythematosus or Sharp's Syndrome
A Phase 1 study, sponsored by Arkansas Heart Hospital.
- Terminated
- Registry status
- Phase 1
- Development phase
- 2
- Enrollment target
NCT02741362 is a Phase 1 study that was terminated before completion, run by Arkansas Heart Hospital. The registered enrollment target is 2 participants.
The verdict
NCT02741362, a Phase 1 study, was terminated before completion, sponsored by Arkansas Heart Hospital.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 2 participants
- Enrollment target
Study 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.
Interventions
- OTHER Intravenous injection of Stromal Vascular Fraction Cells (SVF) containing ADSCs
- OTHER Lipoaspiration
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2015-12 |
| Est. Completion | 2016-12-31 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02741362
The ClinicalTrials.gov registry entry for NCT02741362 describes a study currently listed as terminated, categorized as Phase 1. The registered enrollment target is 2 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Arkansas Heart Hospital, which has 7 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Intravenous injection of Stromal Vascular Fraction Cells (SVF) containing ADSCs is the first listed.
NCT02741362 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02741362 about?
NCT02741362 is a clinical study titled "Safety and Efficacy of Adipose Derived Stem Cells in Refractory Rheumatoid Arthritis, Systemic Lupus Erythematosus or Sharp's Syndrome". 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 dat...
What is the current status of trial NCT02741362?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 2 participants. The study started on 2015-12. Estimated completion is 2016-12-31.
What interventions are being tested in trial NCT02741362?
The interventions under investigation include: Intravenous injection of Stromal Vascular Fraction Cells (SVF) containing ADSCs (OTHER), Lipoaspiration (OTHER).
Who is sponsoring clinical trial NCT02741362?
This trial is sponsored by Arkansas Heart Hospital, which has 7 total clinical trials registered on ClinicalTrials.gov.
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