Rheumatoid Arthritis Clinical Trial
Official title:
Observational Study to Evaluate the Safety of FURESTEM-RA Inj. in Moderate to Severe Rheumatoid Arthritis Patients Who Participated in Phase 1 Clinical Trial of FURESTEM-RA Inj
| Verified date | August 2017 |
| Source | Kang Stem Biotech Co., Ltd. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
Observational Study to evaluate the safety of FURESTEM-RA lnj. in moderate to severe rheumatoid arthritis patients who participated in phase 1 clinical trial of FURESTEM-RA lnj.
| Status | Active, not recruiting |
| Enrollment | 9 |
| Est. completion date | March 21, 2021 |
| Est. primary completion date | January 24, 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 19 Years to 80 Years |
| Eligibility |
Inclusion Criteria: - Subjects participating in this observational study originally participated in study FURESTEM-RA Inj.[NCT02221258] - Subject who understands and voluntarily sign an informed consent form Exclusion Criteria: - In case follow-up is not possible from end of clinical trial Phase 1 to end of this study period |
| Country | Name | City | State |
|---|---|---|---|
| Korea, Republic of | Seoul national University Boramae medical center | Seoul |
| Lead Sponsor | Collaborator |
|---|---|
| Kang Stem Biotech Co., Ltd. |
Korea, Republic of,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Safety of FURESTEM-RA Inj. | Evaluate the number of adverse events Safety of FURESTEM-RA Inj. | 5 years |
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