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Follow-up Safety and Efficacy Evaluation on Subjects Who Completed Phase I Clinical Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04339504
Recruitment Status : Recruiting
First Posted : April 9, 2020
Last Update Posted : April 24, 2020
Sponsor:
Information provided by (Responsible Party):
Medipost Co Ltd.

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.

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Biological: SMUP-IA-01(low-dose) Biological: SMUP-IA-01(mid-dose) Biological: SMUP-IA-01(high-dose) Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Long-term Follow-up Study of Safety and Explore Efficacy in Subjects Who Completed SMUP-IA-01 Phase Ⅰ Clinical Trial
Actual Study Start Date : April 14, 2020
Estimated Primary Completion Date : December 2025
Estimated Study Completion Date : December 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: 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)
Biological: SMUP-IA-01(low-dose)
A single knee administration of SMUP-IA-01(low-dose, 4.0 x 10^6 cells/2mL)
Other Name: Human umbilical cord blood-derived mesenchymal stem cells

Experimental: 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)
Biological: SMUP-IA-01(mid-dose)
A single knee administration of SMUP-IA-01(mid-dose, 1.0 x 10^7 cells/2mL)
Other Name: Human umbilical cord blood-derived mesenchymal stem cells

Experimental: 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)
Biological: SMUP-IA-01(high-dose)
A single knee administration of SMUP-IA-01(high-dose, 2.0 x 10^7 cells/2mL)




Primary Outcome Measures :
  1. Change of total score in WOMAC (Western Ontario and McMaster University) [ Time Frame: Month 12, 24, 36, 48 and 60 after treatment ]
    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 :
  1. Change of score in WOMAC three subscales (Pain, stiffness, physical function) [ Time Frame: Month 12, 24, 36, 48 and 60 after treatment ]
    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).

  2. Change of score in 100 mm VAS (Visual Analogue Scale) [ Time Frame: Month 12, 24, 36, 48 and 60 after treatment ]
    The score ranges from "0" or no pain to "100" very severe pain

  3. Change of score in IKDC(International Knee Documentation Committee) [ Time Frame: Month 12, 24, 36, 48 and 60 after treatment ]
    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.

  4. Change of score in WORMS(Whole-Organ Magnetic Resonance iMaging Score) [ Time Frame: Month 12 and 24 after treatment ]
    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

  5. Change in K&L(Kellgren-Lawrence) grade [ Time Frame: Month 12 and 24 after treatment ]
    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

  6. Change in joint space width [ Time Frame: Month 12 and 24 after treatment ]
    Evaluation of disease progression in target knee as ascertained by change from baseline in joint space width (JSW) determined using radiography

  7. Change in mechanical axis, anatomical axis [ Time Frame: Month 12 and 24 after treatment ]
    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

  8. 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 ]
    Rate of surgery to treat application site after treatment of SMUP-IA-01

  9. Changes in biomarker [ Time Frame: Month 12 after treatment ]
    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)



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04339504


Contacts
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Contact: Eunyoung LEE 82234656748 ley0113@medi-post.co.kr
Contact: Jungjin Park 82234656641 jjpark@medi-post.co.kr

Locations
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Korea, Republic of
Seoul national University Hospital Recruiting
Seoul, Jongno-gu, Korea, Republic of, 03080
Sponsors and Collaborators
Medipost Co Ltd.
Investigators
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Principal Investigator: Myungchul LEE, MD, PhD Seoul National University Hospital
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Responsible Party: Medipost Co Ltd.
ClinicalTrials.gov Identifier: NCT04339504    
Other Study ID Numbers: MP-SMUP-IA-P01-F/U
First Posted: April 9, 2020    Key Record Dates
Last Update Posted: April 24, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Medipost Co Ltd.:
human umbilical cord blood derived mesenchymal stem cells
Knee Osteoarthritis
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases