Investigator Initiated Trial to Evaluate Cartilage Regeneration by Arthroscopy After JOINTSTEM Administration
1 other identifier
interventional
21
1 country
1
Brief Summary
The purpose of this study is to confirm cartilage regeneration through arthroscopy after a single administration of autologous Adipose Tissue derived Mesenchymal stem cells(JOINTSTEM) in patients with degenerative arthritis of K-L grade 3
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 24, 2021
CompletedFirst Posted
Study publicly available on registry
March 29, 2021
CompletedStudy Start
First participant enrolled
July 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2024
CompletedSeptember 28, 2022
September 1, 2022
1.1 years
March 24, 2021
September 27, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Arthroscopy
Change of damaged cartilage defects after 48 weeks from IP administration, compared to Baseline (Experimental group vs Control group)
48 Weeks
Secondary Outcomes (8)
WOMAC total score
12 weeks, 24 weeks, 48 weeks
WOMAC subscale score
12 weeks, 24 weeks, 48 weeks
VAS score
12 weeks, 24 weeks, 48 weeks
RAND-36
12 weeks, 24 weeks, 48 weeks
IKDC
12 weeks, 24 weeks, 48 weeks
- +3 more secondary outcomes
Study Arms (2)
JOINTSTEM
EXPERIMENTALAutologous Adipose Tissue derived MSCs
Saline
PLACEBO COMPARATORsaline
Interventions
Eligibility Criteria
You may qualify if:
- Age 20 and older, male and female
- Patients must consent in writing to participate in the study by signing and dating an informed consent document
- Diagnosis of degenerative arthritis of class 1-3 by ACR(American College of Rheumatology Criteria) Global functional criteria
- Diagnosis of Kellgren and Lawrence grade 3 by radiographic criteria
- Patients suitable for one of three conditions of 'diagnostic criteria for osteoarthritis of knee' based on ACR guideline
- clinical and inspectional opinion
- clinical and radiographic opinion
- clinical opinion
- Patients who has joint pain ≥ 50mm on 100mm VAS (Visual Analog Scale) at Screening
- Patient who has WOMAC score ≥ 1000 at Screening
- No improvement with persisting knee pain at least for 12 weeks (3 months) by nonoperational therapy before Screening
You may not qualify if:
- Patients who have pregnancy plans within this trial period or childbearing age patients who do not agree to maintain contraception status through appropriate contraception methods
- Appropriate contraception method: Use of condom, contraceptive sponges, foam, diaphragm, intrauterine device etc.
- Periodic abstinence(e.g. methods of predicting ovulation) and moderation are not considered as appropriate contraception method.
- Not allowed to use hormonal contraceptives
- Childbearing age female patients, exclude menopausal female (amenorrhea for more than 24 months after the last menstruation) or female who has no possibility of pregnency by surgical sterilization operation, can participate in this study only determined negative in pregnancy test
- Pregnant women or lactating mothers
- Patients with Body Mass Index (BMI) \> 35
- Patients with positive human immunodeficiency (HIV), hepatitis B (HBV), hepatitis C (HCV), syphilis at screening indicative of current of pass infection
- Patients with other disease including
- Septic arthritis, Rheumatoid or Inflammatory joint disease, Gout, Reccurent pseudogout, Paget disease, Articular fractures, Ochronosis, Acromegaly, Hemochromatosis, Wilson's disease,Osteochondromatosis, Hereditary disorder, Genetic disorder of collagen
- Patients who are diagnosed with malignant tumor in the past or present
- Patients who have clinically significant diseases including
- Cardiac disorder (Myocardial infarction, Coronary artery bypass graft, Arrhythmia and other severe Cardiac disorder etc.)
- Resistant hypertension (systolic blood pressure \> 160mmHg or diastolic pressure \> 100mmHg at Screening)
- Kidney disease (Chronic renal failure, Glomerulonephritis etc.)
- +21 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- R-Biolead
Study Sites (1)
Bethesda Hospital
Yangsan, 50576, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
CHANGMIN LEE, M.D.,Ph.D.
Bethesda Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 24, 2021
First Posted
March 29, 2021
Study Start
July 1, 2023
Primary Completion
August 1, 2024
Study Completion
December 31, 2024
Last Updated
September 28, 2022
Record last verified: 2022-09
Data Sharing
- IPD Sharing
- Will not share