Evaluation Safety and Explore Efficacy Long-term Follow-up Study on Subjects Receiving SMUP-IA-01 or Active Control
Key facts
- Who runs it
- Medipost Co Ltd.
- Where
- South Korea5 sites in 1 countryChoose a country to see its sites
- Trial code
- Status
- Active, not recruiting
- Phase
- Phase 2
- People taking part
- 84 people enrolled
- Started
- 20 Mar 2023
- Expected to end
- 30 Nov 2027
- Type of study
- Interventional, 3 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- SMUP-IA-01(low-dose)
- SMUP-IA-01(mid-dose)
- High Hyal Plus
- Record updated
- 7 February 2025
Who can take part
- Age
- 19 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 4 criteriaShow less
Who can take part
- Subject who completed the safety and explore efficacy evaluations in SMUP-IA-01 Phase II clinical trial
- Subject who voluntarily decided to participate and signed the consent form after receiving explanations on the clinical trial
Who cannot take part
- Subject who were not enrolled in phase II clinical trial of SMUP-IA-01 for assessing safety and explore efficacy
- Other subjects, excluding those listed above, who were deemed unsuitable by the PI
This trial has no sites in United States.
It has sites in one country. Choose a country to see its sites.
About the trial
What the trial wants to find out
This is a follow-up study to investigate the long-term safety and explore efficacy of SMUP-IA-01, for the treatment of Knee Osteoarthritis. Subjects who participated in and completed the initial stage of the Phase II trial (NCT05182034) will be followed-up until 60 months.
The 3 groups in the trial
- SMUP-IA-01(low-dose)Treatment being tested
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(mid-dose)Treatment being tested
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)
- High Hyal Plus Inj.Existing treatment, for comparison
A single knee administration of High Hyal Plus Inj.(1% Sodium Hyaluronate 20mg/2ml)
Treatment: High Hyal Plus
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Record updated
- 7 February 2025