NCT01885819

Autologous Adipose Tissue Stromal Vascular Fraction Cells for Rheumatoid Arthritis

Feasibility Study of Non-Expanded Autologous Adipose Tissue Derived Stromal Vascular Fraction Cells in Disease Modifying Anti-Rheumatic Drugs (DMARD) Resistant Rheumatoid Arthritis

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Translational Biosciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Autologous stromal vascular fraction (SVF) injected at 8 and 10 days after extraction is safe and useful procedure in inducing remission of RA in patients resistant to standard DMARD therapy.

Detailed description

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.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
BIOLOGICAL	Autologous stromal vascular fraction cells

Timeline

• Start date: 2013-06-01
• Primary completion: 2016-07-01
• Completion: 2016-12-01
• First posted: 2013-06-25
• Last updated: 2017-08-10

Locations

1 site across 1 country: Panama