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Clinical Trial to Evaluate the Efficacy and Safety of MegaCarti® in Knee Cartilage Defects

Primary Purpose

Osteoarthritis, Knee

Status
Active
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
MegaCarti®
Microfracture
Sponsored by
L&C Bio
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee focused on measuring Knee Cartilage Defects, microfracture, MegaCarti, cartilage regeneration

Eligibility Criteria

19 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. 19 years to 65 years
  2. Patients or legal representatives who voluntarily decide to participate in the clinical trial, after which sign the consent form.
  3. Defect: International Cartilage Repair Society(ICRS) Grade III or IV single defect chondral lesion on knee cartilage
  4. Patients whose primary lesion site can be designated as one section of the knee joint, and the area can be determined as the main cause of clinical symptoms
  5. knee cartilage defect size : Below 10 ㎠

Exclusion Criteria:

  1. Patients who have autoimmune diseases (Ex. Rheumatoid arthritis)
  2. Patients who underwent surgery related to cartilage defect treatment, such as microfracture, autologous chondrocyte therapy within the past 1 year (Possible for HTO surgery)
  3. When screening, Patients who received intra-articular hyaluronic acid or steroid injections in the knee within 3 months
  4. When screening, Patients who took oral steroid within 1 month
  5. When screening, Patients who have clinically significant abnormalities in blood, serum, or urine tests
  6. Patients taking immunosuppressive drug, or having immune disorder
  7. Patients who can't take MRI scan
  8. Patients with a history of cancer within the past five years
  9. Patients who have chronic renal failure, active hepatitis, or poor blood sugar control
  10. BMI index : 30 ㎏/㎡ or over
  11. Patients who have gout or gout history in the knee
  12. When screening, Women who are pregnant or breast-feeding, or women who are planning for pregnancy during the clinical trial, or women who have a possibility of pregnancy but do not use medically accepted methods of contraception.
  13. Drug and alcohol addiction / dependence or mental disorder
  14. Patients with risk factor for bleeding (Patients taking antithrombotic drugs other than aspirin)
  15. Patients who have systemic or localized knee infection
  16. Other than above, patients who are judged by medical investigator to be considered unsuitable for this clinical trial
  17. Patients who participated in other clinical trials within three months before screening

Sites / Locations

  • National Health Insurance Service Ilsan Hospital
  • Korea University Anam Hospital
  • Yonsei University Health System, Severance Hospital
  • Yonsei University Health System, Gangnam Severance Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

MegaCarti® application after microfracture

Microfracture only

Arm Description

The experimental group is applied with MegaCarti® after microfracture. Afterwards, they visit at 6 weeks, 12 weeks, 24 weeks, and 48 weeks to conduct examinations and assess Questionnaires. Long-term follow-up Study is performed to subject that completes 48-week visit, at every 6 months for 5 years.

The control group undergoes microfracture and they visit at 6 weeks, 12 weeks, 24 weeks, and 48 weeks after surgery to conduct examinations and assess Questionnaires.

Outcomes

Primary Outcome Measures

MOCART score
Primary Endpoint [experimental group / control group]

Secondary Outcome Measures

Comparison of IKDC score
Secondary Endpoint [experimental group / control group]
Comparison of VAS score
Secondary Endpoint [experimental group / control group]
Comparison of KOOS score
Secondary Endpoint [experimental group / control group]
Comparison of WOMAC score
Secondary Endpoint [experimental group / control group]
Comparison of Kellgren-Lawrence grade
Secondary Endpoint [experimental group / control group]
Frequency of rescue medication
Secondary Endpoint [experimental group / control group]

Full Information

First Posted
June 27, 2022
Last Updated
June 27, 2022
Sponsor
L&C Bio
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1. Study Identification

Unique Protocol Identification Number
NCT05440370
Brief Title
Clinical Trial to Evaluate the Efficacy and Safety of MegaCarti® in Knee Cartilage Defects
Official Title
Clinical Trial to Evaluate the Efficacy and Safety of MegaCarti® ; Cartilage Defect Treatment Assisting Cartilage Regeneration in Knee Cartilage Defects : Multicenter, Independent Evaluator and Subject Blinded, Microfracture Comparative, Superiority, Randomized, Confirmatory Clinical Study and 5 Years Follow up Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 16, 2020 (Actual)
Primary Completion Date
June 10, 2022 (Actual)
Study Completion Date
January 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
L&C Bio

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
The MegaCarti® is the decellularized allogeneic cartilage and acts as a cover after bone marrow stimulation to prevent the loss of blood clots and induces cartilage regeneration by assisting in the location of stem cells derived from bone marrow. The MegaCarti® is applied after Microfracture treatment on patients with Knee Cartilage Defects. The cartilage regeneration, which is a primary endpoint, is compared to the Microfracture group through MOCART evaluation. In addition, the improvement of pain and the recovery of Normal Range of motion are compared to the Microfracture group through secondary endpoints. Then, long-term follow-up study for 5 years is conducted to the experimental group.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis, Knee
Keywords
Knee Cartilage Defects, microfracture, MegaCarti, cartilage regeneration

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MegaCarti® application after microfracture
Arm Type
Experimental
Arm Description
The experimental group is applied with MegaCarti® after microfracture. Afterwards, they visit at 6 weeks, 12 weeks, 24 weeks, and 48 weeks to conduct examinations and assess Questionnaires. Long-term follow-up Study is performed to subject that completes 48-week visit, at every 6 months for 5 years.
Arm Title
Microfracture only
Arm Type
Active Comparator
Arm Description
The control group undergoes microfracture and they visit at 6 weeks, 12 weeks, 24 weeks, and 48 weeks after surgery to conduct examinations and assess Questionnaires.
Intervention Type
Device
Intervention Name(s)
MegaCarti®
Intervention Description
MegaCarti® application after microfracture through athroscopic or incision surgery
Intervention Type
Procedure
Intervention Name(s)
Microfracture
Intervention Description
Microfracture through athroscopic or incision surgery
Primary Outcome Measure Information:
Title
MOCART score
Description
Primary Endpoint [experimental group / control group]
Time Frame
48 weeks after surgery
Secondary Outcome Measure Information:
Title
Comparison of IKDC score
Description
Secondary Endpoint [experimental group / control group]
Time Frame
Baseline and 12, 24, 48 weeks after surgery
Title
Comparison of VAS score
Description
Secondary Endpoint [experimental group / control group]
Time Frame
Baseline and 6, 12, 24, 48 weeks after surgery
Title
Comparison of KOOS score
Description
Secondary Endpoint [experimental group / control group]
Time Frame
Baseline and 12, 24, 48 weeks after surgery
Title
Comparison of WOMAC score
Description
Secondary Endpoint [experimental group / control group]
Time Frame
Baseline and 12, 24, 48 weeks after surgery
Title
Comparison of Kellgren-Lawrence grade
Description
Secondary Endpoint [experimental group / control group]
Time Frame
Baseline and 12, 24, 48 weeks after surgery
Title
Frequency of rescue medication
Description
Secondary Endpoint [experimental group / control group]
Time Frame
For 48 weeks after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 19 years to 65 years Patients or legal representatives who voluntarily decide to participate in the clinical trial, after which sign the consent form. Defect: International Cartilage Repair Society(ICRS) Grade III or IV single defect chondral lesion on knee cartilage Patients whose primary lesion site can be designated as one section of the knee joint, and the area can be determined as the main cause of clinical symptoms knee cartilage defect size : Below 10 ㎠ Exclusion Criteria: Patients who have autoimmune diseases (Ex. Rheumatoid arthritis) Patients who underwent surgery related to cartilage defect treatment, such as microfracture, autologous chondrocyte therapy within the past 1 year (Possible for HTO surgery) When screening, Patients who received intra-articular hyaluronic acid or steroid injections in the knee within 3 months When screening, Patients who took oral steroid within 1 month When screening, Patients who have clinically significant abnormalities in blood, serum, or urine tests Patients taking immunosuppressive drug, or having immune disorder Patients who can't take MRI scan Patients with a history of cancer within the past five years Patients who have chronic renal failure, active hepatitis, or poor blood sugar control BMI index : 30 ㎏/㎡ or over Patients who have gout or gout history in the knee When screening, Women who are pregnant or breast-feeding, or women who are planning for pregnancy during the clinical trial, or women who have a possibility of pregnancy but do not use medically accepted methods of contraception. Drug and alcohol addiction / dependence or mental disorder Patients with risk factor for bleeding (Patients taking antithrombotic drugs other than aspirin) Patients who have systemic or localized knee infection Other than above, patients who are judged by medical investigator to be considered unsuitable for this clinical trial Patients who participated in other clinical trials within three months before screening
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seong Hwan Kim, Professor
Organizational Affiliation
Yonsei University Health System, Gangnam Severance Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Health Insurance Service Ilsan Hospital
City
Goyang-si
State/Province
Gyeonggi-do
ZIP/Postal Code
10444
Country
Korea, Republic of
Facility Name
Korea University Anam Hospital
City
Seoul
ZIP/Postal Code
02841
Country
Korea, Republic of
Facility Name
Yonsei University Health System, Severance Hospital
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Yonsei University Health System, Gangnam Severance Hospital
City
Seoul
ZIP/Postal Code
06273
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

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Clinical Trial to Evaluate the Efficacy and Safety of MegaCarti® in Knee Cartilage Defects

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