Back to resultsFollow-up Safety and Efficacy Evaluation on Subjects Who Completed Phase I Clinical Trial
Primary Purpose
Knee Osteoarthritis
Status
Recruiting
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
SMUP-IA-01(low-dose)
SMUP-IA-01(mid-dose)
SMUP-IA-01(high-dose)
Sponsored by
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
Arm Type
Experimental
Experimental
Experimental
Arm Label
SMUP-IA-01(low-dose)
SMUP-IA-01(mid-dose)
SMUP-IA-01(high-dose)
Arm Description
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)
Outcomes
Primary Outcome Measures
Change of total score in WOMAC (Western Ontario and McMaster University)
Comparing WOMAC total score changes with baseline scores of SMUP-IA-01 phase I trial and scores of f/u study at 12 months, 24 months, 36 months, 48 months and 60months after treatment (score range 0-96, higher score represent worse symptoms).
Secondary Outcome Measures
Change of score in WOMAC three subscales (Pain, stiffness, physical function)
The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68).
Change of score in 100 mm VAS (Visual Analogue Scale)
The score ranges from "0" or no pain to "100" very severe pain
Change of score in IKDC(International Knee Documentation Committee)
The scores for each category are summed up and divided into 87, which is the maximum score possible, and then is evaluated by converting it into a scale of 100 points. Higher score indicates better function and less symptoms for the knee.
Change of score in WORMS(Whole-Organ Magnetic Resonance iMaging Score)
For structural and tissue evaluation of knee, MRI image of detailed knee parts are graded from min. 0 to max. 6. Lower number indicate normal status
Change in K&L(Kellgren-Lawrence) grade
The K & L grade is 0 to 4 Grade, which means that the higher the grade, the greater the joint damage and the stenosis of the joint
Change in joint space width
Evaluation of disease progression in target knee as ascertained by change from baseline in joint space width (JSW) determined using radiography
Change in mechanical axis, anatomical axis
The degree of deformation of the lower half of the body is measured by measuring the angles of the mechanical axis and the anatomical axis with respect to the vertical axis. Mechanical axis: A line connecting the femoral head center point and the ankle joint center point. Anatomical axis: The middiaphyseal line of the femur and tibia
Rate of surgery to treat application site after treatment of SMUP-IA-01
Rate of surgery to treat application site after treatment of SMUP-IA-01
Changes in biomarker
Comparing biomarker changes with baseline of SMUP-IA-01 phase I trial and scores of f/u study at 12 months after treatment. urine C-terminal cross-linking telopeptides of collagen type II (CTX II), serum cartilage oligomeric matrix protein (COMP), serum matrix metalloproteinase-3 (MMP-3)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04339504
Brief Title
Follow-up Safety and Efficacy Evaluation on Subjects Who Completed Phase I Clinical Trial
Official Title
Long-term Follow-up Study of Safety and Explore Efficacy in Subjects Who Completed SMUP-IA-01 Phase Ⅰ Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 14, 2020 (Actual)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
December 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medipost Co Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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 I trial (NCT04037345 ) will be followed-up until 60 months.
Detailed Description
The subjects will be followed up at 6-month, 12-month, 24-month, 36-month, 48-month and 60-month after the initial administration of SMUP-IA-01.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
human umbilical cord blood derived mesenchymal stem cells, Knee Osteoarthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
12 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
SMUP-IA-01(low-dose)
Arm Type
Experimental
Arm Description
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)
Arm Title
SMUP-IA-01(mid-dose)
Arm Type
Experimental
Arm Description
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)
Arm Title
SMUP-IA-01(high-dose)
Arm Type
Experimental
Arm Description
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)
Intervention Type
Biological
Intervention Name(s)
SMUP-IA-01(low-dose)
Other Intervention Name(s)
Human umbilical cord blood-derived mesenchymal stem cells
Intervention Description
A single knee administration of SMUP-IA-01(low-dose, 4.0 x 10^6 cells/2mL)
Intervention Type
Biological
Intervention Name(s)
SMUP-IA-01(mid-dose)
Other Intervention Name(s)
Human umbilical cord blood-derived mesenchymal stem cells
Intervention Description
A single knee administration of SMUP-IA-01(mid-dose, 1.0 x 10^7 cells/2mL)
Intervention Type
Biological
Intervention Name(s)
SMUP-IA-01(high-dose)
Intervention Description
A single knee administration of SMUP-IA-01(high-dose, 2.0 x 10^7 cells/2mL)
Primary Outcome Measure Information:
Title
Change of total score in WOMAC (Western Ontario and McMaster University)
Description
Comparing WOMAC total score changes with baseline scores of SMUP-IA-01 phase I trial and scores of f/u study at 12 months, 24 months, 36 months, 48 months and 60months after treatment (score range 0-96, higher score represent worse symptoms).
Time Frame
Month 12, 24, 36, 48 and 60 after treatment
Secondary Outcome Measure Information:
Title
Change of score in WOMAC three subscales (Pain, stiffness, physical function)
Description
The WOMAC measures five items for pain (score range 0-20), two for stiffness (score range 0-8), and 17 for functional limitation (score range 0-68).
Time Frame
Month 12, 24, 36, 48 and 60 after treatment
Title
Change of score in 100 mm VAS (Visual Analogue Scale)
Description
The score ranges from "0" or no pain to "100" very severe pain
Time Frame
Month 12, 24, 36, 48 and 60 after treatment
Title
Change of score in IKDC(International Knee Documentation Committee)
Description
The scores for each category are summed up and divided into 87, which is the maximum score possible, and then is evaluated by converting it into a scale of 100 points. Higher score indicates better function and less symptoms for the knee.
Time Frame
Month 12, 24, 36, 48 and 60 after treatment
Title
Change of score in WORMS(Whole-Organ Magnetic Resonance iMaging Score)
Description
For structural and tissue evaluation of knee, MRI image of detailed knee parts are graded from min. 0 to max. 6. Lower number indicate normal status
Time Frame
Month 12 and 24 after treatment
Title
Change in K&L(Kellgren-Lawrence) grade
Description
The K & L grade is 0 to 4 Grade, which means that the higher the grade, the greater the joint damage and the stenosis of the joint
Time Frame
Month 12 and 24 after treatment
Title
Change in joint space width
Description
Evaluation of disease progression in target knee as ascertained by change from baseline in joint space width (JSW) determined using radiography
Time Frame
Month 12 and 24 after treatment
Title
Change in mechanical axis, anatomical axis
Description
The degree of deformation of the lower half of the body is measured by measuring the angles of the mechanical axis and the anatomical axis with respect to the vertical axis. Mechanical axis: A line connecting the femoral head center point and the ankle joint center point. Anatomical axis: The middiaphyseal line of the femur and tibia
Time Frame
Month 12 and 24 after treatment
Title
Rate of surgery to treat application site after treatment of SMUP-IA-01
Description
Rate of surgery to treat application site after treatment of SMUP-IA-01
Time Frame
Month 6, 12, 24, 36, 48 and 60 after treatment
Title
Changes in biomarker
Description
Comparing biomarker changes with baseline of SMUP-IA-01 phase I trial and scores of f/u study at 12 months after treatment. urine C-terminal cross-linking telopeptides of collagen type II (CTX II), serum cartilage oligomeric matrix protein (COMP), serum matrix metalloproteinase-3 (MMP-3)
Time Frame
Month 12 after treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eunyoung LEE
Phone
82234656748
Email
ley0113@medi-post.co.kr
First Name & Middle Initial & Last Name or Official Title & Degree
Jungjin Park
Phone
82234656641
Email
jjpark@medi-post.co.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Myungchul LEE, MD, PhD
Organizational Affiliation
Seoul National University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul national University Hospital
City
Seoul
State/Province
Jongno-gu
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
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Follow-up Safety and Efficacy Evaluation on Subjects Who Completed Phase I Clinical Trial
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