KCT0005566
Not yet recruiting
未知
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: A Single center, Single-arm, Prospective, investigator-initiated Pilot study
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Samsung Medical Center
- Enrollment
- 3
- Status
- Not yet recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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)
Outcomes
Primary Outcomes
Not specified
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