A Pilot study to Evaluate the Efficacy and Safety of Autologous Adipose tissue-derived Stromal Vascular Fraction(SVF) treatment for the Patients with articular cartilage injury of the knee
- Conditions
- Diseases of the musculo-skeletal system and connective tissue
- Registration Number
- KCT0005566
- Lead Sponsor
- Samsung Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 3
1) Adults aged 19 to 65
2) Patients requiring Microfracture Surgery with articular cartilage lesions in the knee joint, and those with a Modified Outerbridge classification of Grade 3 or 4
3) Those whose joint cartilage lesions are 3cm2 or more in size
4) Those who participate in the clinical trial, observe treatment and procedures, and are willing to visit the hospital for all observational evaluation
5) A person who voluntarily signs a written consent after hearing the explanation of the purpose and method of this clinical trial
1) Those who have already had the Microfracture Surgery or treatment at the treatment site
2) Those with a Body Mass Index (BMI) of higher than 35
3) Those who are pregnant or nursing, or who are of childbearing age, do not agree to maintain contraception during the clinical period
* Medically accepted contraceptive methods: condoms, oral contraceptives lasting for at least 3 months, injectable or implantable contraceptives, and intrauterine contraceptives installed, etc.
4) Those who are expected to increase bleeding because they cannot stop taking antithrombotic drugs or anticoagulants before surgery
5) Those with malignant tumors or history of malignant tumors within 5 years
6) Those with diabetes with severe complications
7) Those who are judged that the dawn is short (terminal patient)
8) Those who cannot understand the purpose and method of the clinical trial
9) Those who participated in other medical device intervention clinical trials within 6 months before participating in this study (in the case of drug intervention clinical trials, those who participated within 30 days)
10) Others, those who are judged to be difficult to conduct this clinical trial by Investigator
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change of Modified Outerbridge classification with MRI
- Secondary Outcome Measures
Name Time Method Change of Modified Outerbridge classification with MRI;Change of VAS;Change of WOMAC;Change of Lysholm Score;Change of KL grade with X-ray