An observational study in Knee Osteoarthritis, sponsored by Kang Stem Biotech Co., Ltd.. Not yet recruiting. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2023-08-30.
Sponsored by Kang Stem Biotech Co., Ltd. · Observational
Long-Term Follow-up Study of Subjects with Knee Osteoarthritis who had administered FURESTEM-OA Kit Inj. in K0701 study
3,292 studies on the registry are indexed under Osteoarthritis, Knee; 621 are open to participants now.
This study's planned enrollment of 58 is below the median of 100 across 486 observational studies indexed under Osteoarthritis, Knee.
Browse Osteoarthritis, Knee studies →Kang Stem Biotech Co., Ltd. is the lead sponsor of 19 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Those who participated in the K0701 clinical trial and received PureStem-OA Kit Inj
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
exclusion criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Number of AESI
Time frame: 5 years follow-up after treatment
Number of SS
Time frame: 5 years follow-up after treatment
Changes in Knee Injury and Osteoarthritis Outcome Score (KOOS)
The higher the score, the worse the condition of the disease is.
Time frame: 1 year (52 weeks), 2 years (104 weeks), and 3 years (156 weeks) after treatment
Changes in Western Ontario and McMaster Universities osteoarthritis index (WOMAC)
The WOMAC evaluation is evaluated using the score value converted through the KOOS evaluation paper.
Time frame: 1 year (52 weeks), 2 years (104 weeks), and 3 years (156 weeks) after treatment
Changes in 100-mm VAS
Time frame: 1 year (52 weeks), 2 years (104 weeks), and 3 years (156 weeks) after treatment
Changes in International Knee Documentation Committee Scoring System (IKDC)
A higher score indicates better function and less symptomatic
Time frame: 1 year (52 weeks), 2 years (104 weeks), and 3 years (156 weeks) after treatment
Evaluation of International K&L grade(X-ray)
Grade 0 - No radioligical findings of osteoarthritis Grade 1 - Doubtful narrowing of joint space and possible osteophytic lipping Grade 2 - Definite osteophytes and possible narrowing of joint space Grade 3 - Moderate osteophytes, definite narrowing of joint space, and some sclerosis and deformity of bone ends Grade 4 - Large osteophytes, marked narrowing of joint space, severe sclerosis, and definite deformity of bone ends
Time frame: 1 year (52 weeks), 2 years (104 weeks), and 3 years (156 weeks) after treatment
Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) scores(MRI)
A higher score indicates better function and less symptomatic
Time frame: 1 year (52 weeks), 2 years (104 weeks), and 3 years (156 weeks) after treatment
Whole-Organ Magnetic Resonance Imaging Score (WORMS) score
The higher the score means normal state.
Time frame: 1 year (52 weeks), 2 years (104 weeks), and 3 years (156 weeks) after treatment
No study locations are listed for this record.
Start is estimated for Sep 2023; primary completion for Nov 2029, 73 months later.
Of 220 observational studies under Osteoarthritis, Knee, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 61. This study's planned 73 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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Kang Stem Biotech Co., Ltd.