Autologous Adipose Tissue Stromal Vascular Fraction Cells for Rheumatoid Arthritis
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|ClinicalTrials.gov Identifier: NCT01885819|
Recruitment Status : Withdrawn (per sponsor decision)
First Posted : June 25, 2013
Last Update Posted : August 10, 2017
|Condition or disease||Intervention/treatment||Phase|
|Rheumatoid Arthritis||Biological: Autologous stromal vascular fraction cells||Phase 1 Phase 2|
The proposed study will assess primarily safety and secondary efficacy endpoints of autologous stromal vascular fraction (SVF) cells administered to 20 patients with disease modifying antirheumatic drug (DMARD)-resistant Rheumatoid Arthritis (RA) who have been nonresponsive to at least one course of one DMARD selected from a group comprising of: gold salts, leflunomide, methotrexate, and hydroxychloroquine.
The primary objective of safety will be defined as freedom from treatment associated adverse events for the period of one year. The secondary objective of efficacy will include evaluation at baseline and at months 1, 2, 3 and 6 of efficacy endpoints of CRP, ESR, anti-citrulline antibody, RF, Quality of Life Questionnaire, 28-joint disease activity score (DAS28), European League against Rheumatism (EULAR) response criteria and immunological parameters.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Feasibility Study of Non-Expanded Autologous Adipose Tissue Derived Stromal Vascular Fraction Cells in Disease Modifying Anti-Rheumatic Drugs (DMARD) Resistant Rheumatoid Arthritis|
|Study Start Date :||June 2013|
|Estimated Primary Completion Date :||July 2016|
|Estimated Study Completion Date :||December 2016|
Autologous stromal vascular fraction cells
Biological: Autologous stromal vascular fraction cells
- Number of participants with adverse events [ Time Frame: 6 months ]
- Change from baseline 28-DAS Score at 6 months [ Time Frame: 6 months ]
- Change from baseline EULAR Response Criteria at 6 months [ Time Frame: 6 months ]Change in European League against Rheumatism (EULAR) response criteria and immunological parameters from baseline to 6 months.
- Change from baseline quality of life measure (based on Stanford HAQ) at 6 months [ Time Frame: 6 months ]
- Change from baseline C-reactive protein at 6 months [ Time Frame: 6 months ]
- Change from baseline erythrocyte sedimentation rate (ESR) at 6 months [ Time Frame: 6 months ]
- Change from baseline anti-citrulline antibody measure at 6 months [ Time Frame: 6 months ]
- Change from baseline rheumatoid factor (RF) at 6 months [ Time Frame: 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01885819
|Stem Cell Institute|
|Panama City, Panama|
|Principal Investigator:||Jorge Paz-Rodriguez, MD||Stem Cell Institute|