Follow-up Safety and Efficacy Evaluation on Subjects Who Completed Phase I Clinical Trial
NCT ID: NCT04339504
Last Updated: 2023-03-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
12 participants
INTERVENTIONAL
2020-04-14
2025-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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SMUP-IA-01(low-dose)
A single knee administration of SMUP-IA-01 (low-dose, 4.0 x 10\^6 cells/2mL) (2 ml of 1% sodium hyaluronate injection is administered before administration of SMUP-IA-01)
SMUP-IA-01(low-dose)
A single knee administration of SMUP-IA-01(low-dose, 4.0 x 10\^6 cells/2mL)
SMUP-IA-01(mid-dose)
A single knee administration of SMUP-IA-01 (mid-dose, 1.0 x 10\^7 cells/2mL) (2 ml of 1% sodium hyaluronate injection is administered before administration of SMUP-IA-01)
SMUP-IA-01(mid-dose)
A single knee administration of SMUP-IA-01(mid-dose, 1.0 x 10\^7 cells/2mL)
SMUP-IA-01(high-dose)
A single knee administration of SMUP-IA-01 (high-dose, 2.0 x 10\^7 cells/2mL) (2 ml of 1% sodium hyaluronate injection is administered before administration of SMUP-IA-01)
SMUP-IA-01(high-dose)
A single knee administration of SMUP-IA-01(high-dose, 2.0 x 10\^7 cells/2mL)
Interventions
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SMUP-IA-01(low-dose)
A single knee administration of SMUP-IA-01(low-dose, 4.0 x 10\^6 cells/2mL)
SMUP-IA-01(mid-dose)
A single knee administration of SMUP-IA-01(mid-dose, 1.0 x 10\^7 cells/2mL)
SMUP-IA-01(high-dose)
A single knee administration of SMUP-IA-01(high-dose, 2.0 x 10\^7 cells/2mL)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
2. Other subjects, excluding those listed above, who were deemed unsuitable by the PI
19 Years
ALL
No
Sponsors
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Medipost Co Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Myungchul LEE, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Hospital
Locations
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Seoul national University Hospital
Seoul, Jongno-gu, South Korea
Countries
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Central Contacts
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Other Identifiers
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MP-SMUP-IA-P01-F/U
Identifier Type: -
Identifier Source: org_study_id
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