Ignite Creation Date:
2025-12-25 @ 12:16 AM
Ignite Modification Date:
2026-03-06 @ 11:25 PM
Study NCT ID:
NCT02221258
Status:
COMPLETED
Last Update Posted:
2016-10-06
First Post:
2014-08-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety of FURESTEM-RA Inj. in Patients With Moderate to Severe Rheumatoid Arthritis(RA)
Sponsor:
Kang Stem Biotech Co., Ltd.
Organization:
Study Overview
Official Title:
Phase 1 Clinical Trial to Evaluate the Safety of FURESTEM-RA Inj. in Patients With Moderate to Severe Rheumatoid Arthritis
Status:
COMPLETED
Status Verified Date:
2015-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RA
Brief Summary:
The purpose of phase 1 clinical trial is to to evaluate safety in subjects with moderate to severe rheumatoid arthritis after infusion.
Detailed Description:
Rheumatoid arthritis(RA) is a chronic and progressive autoimmune disease characterized by synovial hyperplasia and joint damage leading to clinically significant functional impairment. In RA, for some unknown reason, immune cells infiltrate into synovium of joint and produce the 'rheumatoid factor', prostaglandins, cytokines and other mediators. It damages joint and cartilage, even other organs. 80% of the RA patients have Rheumatoid factor which is caused by high expression ratio of auto-antibodies in blood. Produced immune complexes, immune cells and antigen-presenting cells(including macrophages, B cells, dendritic cells) activate and release cytokines and then synovial tissue becomes thickened and damaged.
It has been reported that synthetic DMARDs(disease-modifying antirheumatic drugs) including methotrexate(MTX), sulfasalazine and biological DMARDs such as tumor necrosis factors(TNF)-α blockers, abatacept and rituximab, often in combination with MTX, are effective. But they still are limited by lack or loss of efficacy in certain patients and serious complications such as serious infections and malignancies. So, there is a need to identify new treatment.
FURESTEM-RA Inj. is composed of allogeneic hUCB-MSC(human Umbilical Cord Blood derived-Mesenchymal Stem cell). hUCB-MSCs are mesenchymal stem cells from umbilical cord blood. Mesenchymal stem cells are well-known for immunosuppression, anti-inflammatory ability and capable of differentiating into a wide range of cell types including osteocytes and chondrocytes. Therefore, FURESTEM-RA Inj. has huge possibility as cell therapy products for RA patients.
It has been reported that synthetic DMARDs(disease-modifying antirheumatic drugs) including methotrexate(MTX), sulfasalazine and biological DMARDs such as tumor necrosis factors(TNF)-α blockers, abatacept and rituximab, often in combination with MTX, are effective. But they still are limited by lack or loss of efficacy in certain patients and serious complications such as serious infections and malignancies. So, there is a need to identify new treatment.
FURESTEM-RA Inj. is composed of allogeneic hUCB-MSC(human Umbilical Cord Blood derived-Mesenchymal Stem cell). hUCB-MSCs are mesenchymal stem cells from umbilical cord blood. Mesenchymal stem cells are well-known for immunosuppression, anti-inflammatory ability and capable of differentiating into a wide range of cell types including osteocytes and chondrocytes. Therefore, FURESTEM-RA Inj. has huge possibility as cell therapy products for RA patients.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: