Follow-up Safety and Efficacy Evaluation on Subjects Who Completed Phase I Clinical Trial
Knee Osteoarthritis
About this trial
This is an interventional treatment trial for Knee Osteoarthritis focused on measuring human umbilical cord blood derived mesenchymal stem cells, Knee Osteoarthritis
Eligibility Criteria
Inclusion Criteria:
- Subject who completed the safety and explore efficacy evaluations in SMUP-IA-01 Phase I clinical trial.
- Subjects who have been treated with either SMUP-IA-01 at least 6 months ago.
- Subjects who voluntarily decided to participate and signed the consent form after receiving explanations on the clinical trial.
Exclusion Criteria:
- Subjects who were not enrolled in phase 1 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
Sites / Locations
- Seoul national University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Experimental
Experimental
Experimental
SMUP-IA-01(low-dose)
SMUP-IA-01(mid-dose)
SMUP-IA-01(high-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)
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)
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)