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

Rheumatoid Arthritis Clinical Trial

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 Rheumatoid Arthritis, Relapsing Systemic Lupus Erythematosus or Sharp's Syndrome

Status Terminated

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02741362
Study type	Interventional
Source	Arkansas Heart Hospital
Contact
Status	Terminated
Phase	Phase 1
Start date	December 2015
Completion date	December 31, 2016

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT04226131` - MusculRA: The Effects of Rheumatoid Arthritis on Skeletal Muscle Biomechanics	N/A
Completed	`NCT04171414` - A Study to Evaluate Usability of Subcutaneous Auto-injector of CT-P17 in Patients With Active Rheumatoid Arthritis	Phase 3
Completed	`NCT02833350` - Safety and Efficacy Study of GDC-0853 Compared With Placebo and Adalimumab in Participants With Rheumatoid Arthritis (RA)	Phase 2
Completed	`NCT04255134` - Biologics for Rheumatoid Arthritis Pain (BIORA-PAIN)	Phase 4
Recruiting	`NCT05615246` - Exactech Humeral Reconstruction Prosthesis of Shoulder Arthroplasty PMCF (HRP)
Completed	`NCT03248518` - Lessening the Impact of Fatigue in Inflammatory Rheumatic Diseases	N/A
Completed	`NCT03514355` - MBSR in Rheumatoid Arthritis Patients With Controlled Disease But Persistent Depressive Symptoms	N/A
Recruiting	`NCT06005220` - SBD121, a Synbiotic Medical Food for RA Management	N/A
Recruiting	`NCT05451615` - Efficacy and Safety of Abatacept Combined With JAK Inhibitor for Refractory Rheumatoid Arthritis	Phase 3
Completed	`NCT05054920` - Eccentric Versus Concentric Exercises for Rotator Cuff Tendinopathy in Patients With Rheumatoid Arthritis	N/A
Completed	`NCT02037737` - Impact and Use of Abatacept IV for Rheumatoid Arthritis in Real Life Setting	N/A
Recruiting	`NCT04079374` - Comparative Efficacy, Safety and Immunogenicity Study of Etanercept and Enbrel	Phase 3
Completed	`NCT02504268` - Effects of Abatacept in Patients With Early Rheumatoid Arthritis	Phase 3
Recruiting	`NCT05496855` - Remote Care in People With Rheumatoid Arthritis	N/A
Completed	`NCT05051943` - A Study of the Real-world Use of an Adalimumab Biosimilar and Evaluation of Nutritional Status on the Therapeutic Response
Recruiting	`NCT06103773` - A Study of Single and Multiple Oral Doses of TollB-001	Phase 1
Recruiting	`NCT06031415` - Study of GS-0272 in Participants With Rheumatoid Arthritis	Phase 1
Completed	`NCT05999266` - The Cartilage and Muscle Thickness on Knee Pain in Patients With Rheumatoid Arthritis
Recruiting	`NCT05302934` - Evaluation of the PHENO4U Data Platform in Patients Undergoing Total Knee Arthroplasty
Recruiting	`NCT04169100` - Novel Form of Acquired Long QT Syndrome	Phase 4

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.