Long-term follow-up on safety and effectiveness of a stem cell treatment for knee osteoarthritis
Long-term Follow-up Study of Safety and Explore Efficacy in Subjects Who Completed SMUP-IA-01 Phase Ⅰ Clinical Trial
This study is testing a stem cell treatment for knee osteoarthritis to see how safe and effective it is over a long period for people who have already tried it.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Medipost Co Ltd. Industry-sponsored |
| Locations | 1 site (Seoul, Jongno-gu) |
| Trial ID | NCT04339504 on ClinicalTrials.gov |
What this trial studies
This follow-up study aims to evaluate the long-term safety and efficacy of SMUP-IA-01, a treatment derived from human umbilical cord blood mesenchymal stem cells, for patients with knee osteoarthritis. Participants who completed the initial Phase I trial will be monitored over a period of up to 60 months, with follow-up assessments occurring at 6, 12, 24, 36, 48, and 60 months post-treatment. The study will analyze the outcomes related to the treatment's effectiveness and any potential long-term side effects.
Who should consider this trial
Good fit: Ideal candidates are individuals who have previously participated in the Phase I trial of SMUP-IA-01 and completed the safety and efficacy evaluations.
Not a fit: Patients who did not participate in the initial Phase I trial or those deemed unsuitable by the principal investigator will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the long-term benefits and safety of stem cell therapy for patients suffering from knee osteoarthritis.
How similar studies have performed: Other studies involving stem cell therapies for knee osteoarthritis have shown promise, but this specific follow-up evaluation is novel in its long-term focus.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Subject who completed the safety and explore efficacy evaluations in SMUP-IA-01 Phase I clinical trial. 2. Subjects who have been treated with either SMUP-IA-01 at least 6 months ago. 3. Subjects who voluntarily decided to participate and signed the consent form after receiving explanations on the clinical trial. Exclusion Criteria: 1. Subjects who were not enrolled in phase 1 clinical trial of SMUP-IA-01 for assessing safety and explore efficacy. 2. Other subjects, excluding those listed above, who were deemed unsuitable by the PI
Where this trial is running
Seoul, Jongno-gu
- Seoul national University Hospital — Seoul, Jongno-gu, Korea, Republic of (Recruiting)
Study contacts
- Principal investigator: Myungchul LEE, MD, PhD — Seoul National University Hospital
- Study coordinator: Eunyoung LEE
- Email: ley0113@medi-post.co.kr
- Phone: 82234656748
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.